FDA Approval for Generic Version of AstraZeneca’s SEROQUEL XR® Extended Release Tablets
Tainan City, Taiwan, May 10, 2017 — Handa Pharmaceuticals, Inc. (Taiwan Exchange: 6620) (“Handa”), a specialty pharmaceutical company focusing on the research, development and commercialization of innovative prescription brand and high-barrier generic drug products, announced that its partner, Par Pharmaceutical, Inc. an Endo International company (“Par”), received final approval from the U.S. Food and Drug Administration (“FDA”) on May 9, 2017 for its Abbreviated New Drug Application (“ANDA”) number 090482 for Quetiapine Fumarate Extended-release Tablets in 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg dosage strengths. Based on available information, the Company believes that three additional companies also received final FDA approvals of their Quetiapine XR ANDAs on the same day. In addition, a fourth competitor launched a competing Authorized Generic product in early May.
Par’s Quetiapine XR ANDA was developed by Handa and acquired by Par on August 3, 2012. Handa retains the right to a portion of profits from the sale of the product, pursuant to its agreement with Par. FDA has designated the ANDA as a pharmacy-substitutable, “AB-rated” Therapeutic Equivalent to the branded product, SEROQUEL XR® Extended Release Tablets, which is marketed in the United States by AstraZeneca Pharmaceuticals LP (“AstraZeneca”). Handa was the first applicant to file a substantially complete ANDA for SEROQUEL XR® Extended Release Tablets in 50 mg, 150 mg, 200 mg, and 300 mg dosage strengths containing Paragraph IV certifications and Par’s ANDA product was entitled to 180 days of generic marketing exclusivity under the United States’ Drug Price Competition and Patent Term Restoration Act, as amended, informally known as the Hatch-Waxman Act. Par’s 180 days of generic marketing exclusivity began on November 1, 2016 when it launched an Authorized Generic product supplied by AstraZeneca pursuant to Handa’s settlement agreement with AstraZeneca.
“FDA’s final approval of the Quetiapine XR ANDA developed by Handa further illustrates Handa’s ability to develop high quality, complex formulations, and represents an important milestone for the product and for Handa as a company,” said Bill Liu, Handa’s President and CEO. “This is the third complex oral dosage product developed by Handa that has been approved by FDA. We are pleased with this accomplishment.”
SEROQUEL XR® Extended Release Tablets contain the active ingredient quetiapine fumarate, an atypical antipsychotic medication, and are indicated for schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder. According to QuintilesIMS, sales of SEROQUEL XR® Extended Release Tablets and generic equivalents in the United States for the 12 months ended March 31, 2017 were approximately $1.272 billion U.S. dollars.
Cautionary Statement Regarding Forward-Looking Information
This release contains various forward-looking statements, including, without limitation, those statements with respect to markets, revenues and operations. All such forward-looking statements are only management’s estimates at the present time. No assurances can be made that any of these estimates will materialize. The estimates are based upon current information and certain external factors, some of which are beyond the control of the Company. The estimates are subject to various assumptions. Many of these assumptions may not be correct and are subject to risks such as unforeseen market changes and supply chain disruptions.