Wednesday 22 October, 2008

Para IV filings: Mylan (Cyclobenzaprine Hydrochloride ER Capsules), Barr (oxymorphone hydrochloride ER tablets) and Par (Sumatriptan/Naproxen)

Mylan (Cyclobenzaprine Hydrochloride ER Capsules)
Innovator Cephalon and Eurand has confirmed the receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the USFDA by Mylan Pharma, requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules).

Barr (oxymorphone hydrochloride ER tablets)
Barr Pharma confirmed that it has initiated a challenge of the patents listed by Endo Pharmaceuticals Inc. in connection with its Opana(R) ER (Oxymorphone hydrochloride) extended-release tablets, 5 mg, 10 mg, 20 mg and 40 mg.

Par (Sumatriptan 85 mg/Naproxen sodium 500 mg tablets)
Innovator Pozen and GlaxoSmithKline (GSK) has confirmed that they received a Para IV letter from Par Pharma on Treximet (Sumatriptan 85 mg/Naproxen sodium 500 mg). Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of following Orange Book listed patents, with following starategy:
US5037845: (Expiry: Aug 6, 2008)- Para III
US6060499 (Expiry: Aug 14, 2017)- Para IV
US6586458 (Expiry: Aug 14, 2017)- Para IV
US7332183. (Expiry: Oct 2, 2025)- Para IV
Earlier, innovator got approval on this combination on Apr 15, 2008. The New combination exclusivity on this product will expire on Apr 15, 2011.

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