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Patent suit filed against Dr Reddy’s

New Jersey-based The Medicines Company has filed a petition in a US court alleging the Hyderabad-based company was infringing upon its patent for manufacture of generic bivalirudin.

Patent suit filed against Dr Reddy’s

Yet another US drugmaker has sued Dr Reddy’s Laboratories (DRL) alleging patent infringement.  New Jersey-based The Medicines Company has filed a petition in a US court alleging the Hyderabad-based company was infringing upon its patent for manufacture of generic bivalirudin.

The US company markets the drug under the brand Angiomax in 250 mg vials. The intravenous drug is an anti-coagulant for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.  The Medicines Company, set up in 1996, currently has two products in the market —- Angiomax and Cleviprex (clevidipine butyrate).

The exact market size of Angiomax could not be ascertained, though estimates peg it at $100-120 million in the last quarter.
“DRL admits that its proposed product infringes the patent because DRL’s notice letter does not include Paragraph IV certification asserting non-infringement of any claim of the patent,” the company said in its filing with the court.

Bivalirudin is a direct thrombin inhibitor and a synthetic congener of the naturally occurring drug hirudin.

The US company has also made another Hyderabad-based company, Gland Pharma, a party to the dispute.
This isn’t the first instance of Dr Reddy’s being sued by a global pharma company for patent infringement.

In the last week of April, Pozen and AstraZeneca filed a suit against it for infringement of patent related to Vimovo delayed-release tablets. In April last year, FDA approved Vimovo delayed-release tablets for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Earlier, Takeda Pharmaceutical had filed a suit alleging infringement of patents of acid reflux treatment drug Dexilant (dexlansoprazole).

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