July 12, 2014 10:40 PM ET

Pharmaceuticals

Company Overview of Anchen Pharmaceuticals, Inc.

Company Overview

Anchen Pharmaceuticals, Inc. engages in the development, manufacture, marketing, distribution, and sale of specialty pharmaceutical products to patients primarily in the United States. It focuses on the development and commercialization of generic products and new drug products that fulfill unmet medical needs. The company also provides tretinoin capsules for the treatment of acute promyelocytic leukemia. The company was founded in 2004 and is headquartered in Irvine, California. Anchen Pharmaceuticals, Inc. operates as a subsidiary of Anchen Incorporated.

9601 Jeronimo Road

Irvine, CA 92618-2025

United States

Founded in 2004

Phone:

949-837-6178

Fax:

949-837-6120

Key Executives for Anchen Pharmaceuticals, Inc.

Founder
Age: 62
Senior Vice President of Regulatory Affairs
Compensation as of Fiscal Year 2014.

Anchen Pharmaceuticals, Inc. Key Developments

Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corp., Torrent Pharmaceuticals, Mylan, Inc., and Mylan Pharmaceuticals Inc. Announces Lawsuit Updates

AstraZeneca PLC reported that on February 14, 2013, the US Court of Appeals for the Federal Circuit summarily upheld a lower court ruling that had found the formulation patent protecting the atypical antipsychotic product, Seroquel XR (quetiapine fumarate) extended-release tablets, to be valid and infringed. The firm reported that in March 2012, the US District Court for the District of New Jersey found the formulation patent to be valid. The court also ruled that Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corp., Torrent Pharmaceuticals, Mylan, Inc., and Mylan Pharmaceuticals Inc. had infringed the formulation patent. Currently, no generic versions of Seroquel XR have been approved by the FDA. The product is protected by one unexpired patent, US Patent No. 5,948,437, which expires on May 28, 2017, but has additional paediatric exclusivity until November 28, 2017.

Sucampo Pharma Files Lawsuit Against Anchen Pharmaceuticals, Inc., Par Pharmaceutical, Inc. and Par Pharmaceutical Companies Inc

Sucampo Pharmaceuticals Inc. announced that it, its affiliate Sucampo AG, R-Tech Ueno Ltd., Takeda Pharmaceutical Company Ltd. and certain affiliates of Takeda have filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. regarding an Abbreviated New Drug Application or ANDA that Anchen filed with the U.S. Food and Drug Administration or FDA to market a generic version of AMITIZA oral capsules, 8 mcg and 24 mcg. The suit claims infringement of six patents that are listed in the FDA's Orange Book and that are scheduled to expire between 2020 and 2027. Sucampo commenced the lawsuit within 45 days from the receipt of a Notice letter sent by Anchen, dated December 26, 2012, concerning its filing of its ANDA. As per the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Anchen's ANDA would be stayed up to 30 months from the January 2, 2013 date of receipt of the Notice letter.

Anchen Pharmaceuticals, Inc. Receives Final Approval from FDA for Tretinoin Capsules, 10 Mg

Par Pharmaceutical Companies, Inc. announced that its operating subsidiary, Anchen Pharmaceuticals, Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated Drug Application for tretinoin capsules, 10 mg. Tretinoin capsules is the generic version of Vesanoid(R) capsules and is used in the treatment of acute promyelocytic leukemia. Par expects to begin shipping the product before the end of the month. Tretinoin Capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3, characterized by the presence of the (15;17) translocation and/or the presence of the PML/RARalpha gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with tretinoin. Tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.

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