Pfizer sued Indian companies@Bosutinib Monohydrate

Wyeth LLC, Wyeth Pharmaceuticals Inc. (“Wyeth Inc.”) and PF PRISM C.V., (collectively, “Plaintiffs” or “Pfizer”), lodged a complaint against Alembic Pharmaceuticals, Ltd., Alembic Pharmaceuticals, Inc. (collectively “Alembic”), and Sun Pharmaceutical Industries, Inc. (“Sun”), for infringement of United States Patent No. 7,417,148 (the “’148 patent”) and United States Patent No. 7,767,678 (the “’678 patent”), and against Sun for infringement of the ’678 patent. Case 1:16-cv-01305-UNA

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Bosutinib monohydrate 

Background :

Alembic Pharmaceuticals, Ltd.’s filed an Abbreviated New Drug Application (“ANDA”) No. 209543 seeking approval by the United States Food and Drug Administration (“FDA”) to sell generic copies of Pfizer’s drug Bosulif® prior to the expiration of the ’678 and ’148 patents, and Sun’s filing of ANDA No. 209577 seeking approval by the FDA to sell generic copies of Bosulif prior to the expiration of the ’678 patent.

US ‘148 claims :

MOT  chronic myelogenous leukemia (CML) using Bosutinib. US ‘148 covers and approved indication. US ‘148 is set to expire on Jan 23, 2026

US ‘678 claims :

Crystalline forms of Bosutinib monohydrate and methods of preparing the same. US ‘678 is set to expire on Nov 23, 2026.

There are total 5 patents listed in OB for Bosulif, which includes US 6,002,008 (expiring March 27, 2018); US 7,919,625 (expiring December 11, 2025); and US RE42376 (expiring September 24, 2019; reissued of US 6,297,258).

In December 2016, U.S. Reissue Patent No. RE42376 received a patent term extension of 1,663 days, which extends its expiration date until April 13, 2024. The paragraph IV notices of Alembic and Sun do not address these three patents. Alembic owns DMF 30552 for Bosutinib.

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