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

EDITORIAL OF THE DAY

  • We must understand the need for P-notes to settle the debate

    The never-ending controversy surrounding participatory notes, aka P-notes, is back in focus following the latest revelation by the Supreme Court-appoi

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

Sarthak Raychaudhuri

vice-president, HR, Asia South Whirlpool of India

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

TODAY'S COLUMNS

Arun Kumar Jain

Managing decisions & bias in 3EE

Leadership is about facing and resolving dilemmas, taking tough calls, ...

Kuruvilla Pandikattu SJ

To see the best in the other

When two people initially develop a loving relationship, the bond ...

Dharmendra Khandal

Creepy, you say? That’s merely ophidiphobia

Snakes are the earliest predators in the life of the ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture