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Home Industry News Cephalon announces notification of filing for cyclobenzaprine hydrochloride

Cephalon announces notification of filing for cyclobenzaprine hydrochloride

23rd October 2008

Cephalon has announced it – along with Eurand – have received of paragraph IV certification notice letter about an abbreviated new drug application (ANDA) which was submitted to the US food and drug administration.

The letter was sent by Mylan Pharmaceuticals, requesting approval to sell and market a generic version of the 15 and 30 mg strengths of Amrix (cyclobenzaprine hydrochloride extended-release capsules).

Cephalon states that in the letter, Mylan claims the US patent number 7,387,793 – called Release Dosage Forms of Skeletal Muscle Relaxants – which was issued to Eurand is invalid, unenforceable and will also not be infringed upon by its use, sale or manufacture of the product described in its ANDA submission.

“The Eurand patent covers extended-release formulations containing the muscle relaxant cyclobenzaprine and expires on February 26, 2025. Cephalon has a three-year period of marketing exclusivity for Amrix that extends until February 2010,” the company adds.

Concluding, Cephalon states the companies will work together in order to determine the “most appropriate” course of action.

In recent days, Cephalon announced it has embarked upon an educational programme aimed at promoting greater awareness about the importance of correctly using prescription opioid medications called When Good Medicines Become Bad Drugs.

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