When did Gleevec become generic?

In February 2016, a generic version of imatinib (Gleevec), the groundbreaking tyrosine kinase inhibitor, was made available in the United States.

Is Gleevec brand or generic?

Yes, there is a generic version of Gleevec known as imatinib mesylate. Imatinib comes in a 100-mg and 400-mg oral tablet. Generic imatinib was approved in the U.S. in Dec. 2015 and was first manufactured by Sun Pharmaceuticals.

Who makes generic imatinib?

Unfortunately, Sun Pharmaceuticals first-generic imatinib in the United States, enjoying 180-day exclusivity, is priced at a near-patented drug price (not 30% lower as announced; Table 1).

Why was Gleevec denied patent in India?

In 2006, pursuant to Section 3(d) of the Indian Patent’s Act, the Indian Patents Office rejected Novartis’ patent application for its drug Glivec, citing that it did not demonstrate any significant changes in therapeutic effectiveness over its pre-existing form, which was already patented outside India [15].

When do the patents on Gleevec expire, and when?

GLEEVEC Market Exclusivity Period (MEP). When do the patents on GLEEVEC expire, and when will generic GLEEVEC be available? When do Gleevec patents expire, and when can generic versions of Gleevec launch? Gleevec is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

Is there a generic version of Gleevec available?

This drug has thirty-four patent family members in twenty-five countries. The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

When does the patent on imatinib expire for gist?

Finally, although the imatinib active ingredient patent has expired, Novartis retains a secondary patent on the use of imatinib for the treatment of GIST. Payers are not able to advertise the availability of generic imatinib for GIST treatment until this use patent expires in 2020.

Is there a generic version of imatinib in the US?

In February 2016, a generic version of imatinib (Gleevec), the groundbreaking tyrosine kinase inhibitor, was made available in the United States. Imatinib has ushered in a new era of targeted oncology drug development, but has also been credited with creating a new era of drug pricing.