Cephalaon sues DRL over leukemia drug

Tags: News
Biopharmaceuticals company Cephalon, Teva’s subsidiary, has sued Dr Reddy’s Laboratories for infringing their patent for leukemia drug ‘Treanda,’ as the Indian company hoped to make a copycat version of this drug intending to sell it a price lower than the brand. The case was filed at the Delaware federal court last week.

Cephalon’s drug treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. The company has been selling the drug in 2008.

The infringement is for patent 8,609,863 (863 patent) and 8,436,190 (190 patent) as well as Patent No. 8,445,524 (the’524 patent). Dr. Reddy’s had filed for an Abbreviated New Drug Application with the United States food and drug administration (USFDA) to be able to make and market the generic versions of this drug.

The 863 patent, entitled “Bendamustine Pharmaceutical Compositions,” was issued on December 17, 2013 to inventors Jason Edward Brittain and Joe CraigFranklin. The ’863 patent is listed in FDA publication as “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the Orange Book. The patent will expire on January 12, 2026.

“DRL filed with FDA an ANDA seeking, approval to manufacture, use, offer for sale, sell in and import into the United States IV powder for infusion, containing 25 mg of bendamustine HCl and 100 mg bendamustineHCl (“DRL’s Bendamustine Product”) prior to the expiration of US Patent No. 8,445,524 (“the’524 patent”), US Patent No. 8,436,190 (“the ’190 patent”) and the ’863 patent,” the company said in its plea.

trushnaudgirkar

@mydigitalfc.com

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • Those willfully defaulting on loans should be blacklisted by Sebi

    As reported by this newspaper’s Monday edition, the Securities and Exchange Board of India (Sebi) has found merit in the Reserve Bank of India’s s

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Arun Kumar Jain

Kickstarting technological innovation

One of the key dimensions of global competitiveness is the ...

Kuruvilla Pandikattu SJ

Developing moral, spiritual capacity

Writing in The Huffington Post, Noam Chomsky, professor emeritus, MIT ...

Gautam Gupta

Manufacturing must keep workers’ welfare in mind

It may be early days yet, but the labour reforms ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture