Cadila gets tentative USFDA approval to manufacture Jentadueto’s generic

The innovator's drug, Jentadueto, got approval in 2012 and is protected by several patents which expire over 2019-2030. Jentadueto and Tradjenta recorded annual sales of EUR EUR1.3bn in 2017.

Oct 12, 2018 07:10 IST India Infoline News Service

Zydus Cadila has received tentative approval (TA) for Linagliptin and Metformin HCL tablets. The drug is sold by Boehringer Ingelheim Pharmaceuticals Inc. under the brand name Jentadueto Tablets. The approval has come in all strengths in which Jentadueto is sold by the innovator, i.e., 2.5mg/500mg, 2.5mg/850mg and 2.5mg/1,000mg.

Boehringer Ingelheim and Eli Lilly and Company received FDA approval for this drug in February 2012. The drug is used in adults with type 2 diabetes mellitus to improve control of blood sugar levels.

Cadila has said that the drug will be manufactured at its formulations manufacturing facility at SEZ, Ahmedabad. The company now has 221 approvals.

Boehringer’s Jentadueto tablets are protected by several patents. The "method of treatment" patent of the drug will expire in February 2019, while the last of its patents on this drug will expire in 2030.

Jentadueto along with Boehringer’s another diabetes Linagliptin drug, Tradjenta, recorded annual sales of EUR1.3bn in 2017, growing 18% yoy.

Note that this is a tentative approval and not a final approval.

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