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Handa Pharmaceuticals Announces Endo Begins Shipping Generic Version of AstraZeneca’s SEROQUEL XR®

November 1, 2016

Handa Pharmaceuticals, Inc. (“Handa”), a specialty pharmaceutical company based in Tainan, Taiwan, announced today that Par Pharmaceutical, Inc. (“Par”), an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL) has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended release (ER) tablets, the generic version of AstraZeneca’s SEROQUEL XR®. As marketer and distributor of the product, Par will have 180 days of marketing exclusivity for these four first-to-file strengths and will share profits with its partners, Handa and Deerfield Generics, L.P., a portfolio company of Deerfield Management Company, L.P. "Par’s launch represents a significant milestone for the product and for Handa as a company," said Bill Liu, Handa's Chairman and CEO. "We are very pleased with the outcome."

SEROQUEL XR® is a once-daily tablet approved in adults for add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and schizophrenia.

According to IMS Health data, U.S. sales of SEROQUEL XR® for the four dosage strengths marketed by Par are approximately $911 million for the 12 months ended September 30, 2016.

About Handa Pharmaceuticals, Inc.

Handa Pharmaceuticals, Inc. is a specialty pharmaceutical company with headquarters in Tainan, Taiwan, and offices in Taipei, Taiwan, Hangzhou, China, and Fremont, California. Handa Pharmaceuticals, LLC is its U.S. subsidiary. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.tw

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.

Company Contact:

Stephen D. Cary
Executive Vice President
Handa Pharmaceuticals, Inc.
(510) 354-3188
stephen.cary@handapharma.com
http://www.handapharma.com.tw

Handa Pharmaceuticals Announces Tentative Approval of First-to-File ANDA for Takeda's DEXILANT®

December 26, 2013

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration ("FDA") has granted tentative approval of the Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, which Handa transferred to Par Pharmaceutical, Inc. in 2012. Based upon available information, Handa believes that it was the first applicant to file an ANDA for DEXILANT® 60 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Upon the ANDA receiving final approval from the FDA, Handa believes that the 60 mg. strength of the product will be entitled to 180 days of marketing exclusivity.
"Working with the Par team to receive tentative approval for Dexlansoprazole represents a significant milestone for the product and for Handa as a company," said Bill Liu, Handa's President and CEO. "We are very pleased with the outcome."

According to IMS Health, annual sales of DEXILANT® 60 mg. in the U.S. were about $854 million for the twelve months ended December 31, 2013.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Company Contact
Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC
(510) 354-2888
stephen.cary@handapharma.com
http://www.handapharma.com

Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for AstraZeneca’s SEROQUEL XR®

October 29, 2012

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. for Handa's Abbreviated New Drug Application ("ANDA") for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s SEROQUEL XR®. Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes the 400 mg dosage strength.

Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Handa will receive a percentage of profits from the sales of the product. Under the terms of a settlement agreement with AstraZeneca, Par has been assigned a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.

Company Contact:
Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC
(510) 354-2888
stephen.cary@handapharma.com
http://www.handapharma.com

Handa Pharmaceuticals Announces Acquisition and License Agreement with Par Pharmaceutical for Its First-to-File ANDA for Takeda's DEXILANT®

April 19, 2012

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. (NYSE: PRX) for Handa's Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, a generic version of Takeda's DEXILANT®. Handa believes that it is the first applicant to file an ANDA for the 60 mg strength of DEXILANT® containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act, which would potentially provide 180 days of marketing exclusivity.

Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute Dexlansoprazole Delayed Release Capsules in the U.S. under the ANDA, subject to final FDA approval. Handa will receive a percentage of profits from the sales of the product.

Handa is currently involved in patent litigation concerning the ANDA in the U.S. District Court for the District of Northern California. Par will assume control of ongoing litigation.

According to IMS Health data, annual sales of DEXILANT® Delayed Release Capsules, 60 mg, in the U.S. are approximately $517 million.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Company Contact:

Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC
(510) 354-2888
stephen.cary@handapharma.com
http://www.handapharma.com

Handa Pharmaceuticals Announces Patent Litigation Settlement With AstraZeneca On its First-to-File ANDA for SEROQUEL XR®

October 3, 2011

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that it has reached an agreement with AstraZeneca to settle its U.S. patent litigation regarding Handa's Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic version of AstraZeneca's SEROQUEL XR®. Handa is the first applicant to file an ANDA for SEROQUEL XR® 50 mg., 150 mg., 200 mg., and 300 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.

Under the terms of the settlement agreement, AstraZeneca has granted Handa a license to enter the U.S. market with a generic version of SEROQUEL XR® on November 1, 2016 or earlier upon certain circumstances. Handa and AstraZeneca have filed a proposed Consent Judgment with the U.S. District Court for the District of New Jersey requesting that the Court dismiss the pending legal action between Handa and AstraZeneca.

"We are pleased to resolve Handa's patent litigation with AstraZeneca on our First-to-File ANDA for Quetiapine XR. This settlement agreement allows Handa to bring a generic version of SEROQUEL XR® to the U.S. market prior to the November 2017 expiration of AstraZeneca's formulation patent, without incurring the uncertainty and risk inherent with patent litigation," said Bill Liu, Handa's President and CEO.

According to IMS Health, annual sales of SEROQUEL XR® in the U.S. were about $883 million for the twelve months ended March 31, 2011.

About Handa Pharmaceuticals, LLC
Handa Pharmaceuticals, LLC is a specialty pharmaceutical company with a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. In March 2011, Handa announced that its ANDA for Dexlansoprazole Delayed Release Capsules 60 mg., a generic version of Takeda's DEXILANT®, had been accepted for review by the U.S. Food and Drug Administration ("FDA"). Based upon available information, Handa believes that it is the first applicant to file an ANDA for DEXILANT® 60 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA for Dexlansoprazole Delayed Release Capsules 60 mg. be approved by the FDA, Handa believes that the product may be entitled to 180 days of generic market exclusivity. For more information, please visit www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.
DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Company Contact
Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC
(510) 354-2888
stephen.cary@handapharma.com
http://www.handapharma.com

Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takeda's DEXILANT®

March 2, 2011

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration ("FDA"). Based upon available information, Handa believes that it is the first applicant to file an ANDA for DEXILANT® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA for Dexlansoprazole Delayed Release Capsules, 60 mg, be approved by the FDA, Handa believes that the product may be entitled to 180 days of generic market exclusivity.

According to IMS Health, annual sales of DEXILANT® Delayed Release Capsules, 60 mg, in the U.S. were about $300 million for the twelve months ended December 31, 2010.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. In December 2010, Handa announced that the U.S. Food and Drug Administration ("FDA") had granted tentative approval of the Company's Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg, a generic version of AstraZeneca's SEROQUEL XR®. Handa is the first applicant to file an ANDA for SEROQUEL XR® 50 mg, 150 mg, 200 mg, and 300 mg containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. For more information, please visit http://www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.

Company Contact:

Stephen Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC
(510) 354-2888
stephen.cary@handapharma.com
http://www.handapharma.com

Handa Pharmaceuticals Announces Tentative Approval of its First-to-File ANDA for AstraZeneca's SEROQUEL XR®

December 13, 2010

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration ("FDA") has granted tentative approval of the Company's Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets, 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic version of AstraZeneca's SEROQUEL XR®. Based upon available information, Handa believes that it is the first applicant to file an ANDA for SEROQUEL XR® 50 mg., 150 mg., 200 mg., and 300 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Upon receiving final approval by the FDA, Handa believes that the 50 mg., 150 mg., 200 mg., and 300 mg. strengths of its product will be entitled to 180 days of marketing exclusivity.

"Receiving tentative approval of our Quetiapine XR ANDA represents a significant milestone for the product and for Handa Pharmaceuticals as a company," said Bill Liu, Handa's President and CEO. "We are executing our plan to build a robust pipeline of controlled release products for global markets."

According to IMS Health, annual sales of SEROQUEL XR® in the U.S. were about $754 million for the twelve months ended September 30, 2010.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit www.handapharma.com

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.

Source: Handa Pharmaceuticals, LLC
Contact: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888

Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca’s SEROQUEL® XR

July 31, 2008

Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZeneca’s SEROQUEL® XR, has been accepted for filing by the U.S. Food and Drug Administration (“FDA”). Based upon available information, Handa believes that it is the first applicant to file an ANDA for SEROQUEL® XR containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by the FDA, Handa believes that its product will be entitled to 180 days of generic market exclusivity.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa’s executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa’s current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL® and SEROQUEL® XR are registered trademarks of the AstraZeneca group of companies.

Source: Handa Pharmaceuticals, LLC
Contact: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888



Handa Pharmaceuticals, LLC
39465 Paseo Padre Parkway Suite 2600
Fremont, California 94538
United States

Phone: (510) 354-2888
Fax: (510) 354-2887

info@handapharma.com