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.
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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