Mylan Pharmaceuticals agrees to resolve patent litigation related to Erlotinib Hydrochloride Tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with OSI, Pfizer and Genentech that will resolve patent litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg. This product is the generic version of TARCEVA®, and is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, had U.S. sales of approximately $638.7 million for the 12 months ending March 31, 2013, according to IMS Health.

Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $23 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.

SOURCE Mylan Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
New biomarkers offer hope for early detection and prevention of Alzheimer's