Hyderabad, June 26 (PTI) Merck Sharp & Dohme Corp has
moved a US court against Dr Reddy''s Laboratories alleging that
the Indian drug maker was planning to come out withthe
generic versions of its multi-billion dollar drugs, Januvia
and Janumet, before expiration ofits patent.
Merck has filed the possible patent infringement petition
against Dr Reddy''s in the United States District Court for the
District of Delaware on four counts.
Januvia (sitagliptin phosphate) and Janumet (metformin
hydrochloride and sitagliptin Phosphate), which are indicated
to control high blood sugar in people with type 2 diabetes
clocked over USD 5.5 billion revenues globally including USD
2.3 billion in USA in 2019.
Patents of Januvia and Janumet will expire in July 2022
for the US with six-month pediatric exclusivity, Merck said in
its 2019 annual report.
Merck in its petition filed on June 23, said Dr Reddys
had submitted ANDAs (abbreviated new drug application) to the
US FDA seeking approval from the health regulator to engage in
commercial manufacture,saleand or importation of intended
generic drugs prior to expiration of the 708 patent.
Merck sought the court, among others, a preliminary and
permanent injunction enjoining Dr Reddy''s and all persons
acting in concert with it, from the commercial manufacture,
use, sale, or importation into the US the Indian drug makers
ANDA Products or any other drug product covered by the patent.
UnderParagraph IVPatentCertifications, a company can
seek FDA approval to market a generic drug before the
expiration ofpatentsrelated to the branded medicine that the
pharma company seeks to copy.
Acity-based pharmaceutical company senior official said
patentinfringementcases are not uncommon for generic drug
makers in the USAand thelawsuit will not have any
implications on the performance of the company.PTI GDK
Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI
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