Sun Pharma shares hit 52-week high despite legal wrangle with Australia’s Mayne Pharma over patent infringement
Sun Pharma stocks were trading in the green, up 2.26 per cent at ₹1,656.30 on July 25 at 2:13 pm on the BSE. The company has a market capitalisation of ₹3,97,212.20 crore.
Sun Pharmaceutical's share price on Thursday, July 25, hit a 52-week high at ₹1,658.00 on NSE, even after Australian drug maker Mayne Pharma initiated legal action against the Indian pharma major over alleged patent infringement. The lawsuit is related to a menopause treatment for vaginal pain, the Australian pharmaceutical company announced on Thursday.
The lawsuit, filed in the United States District Court for New Jersey, claimed that Sun Pharma violated all 20 patents listed in the FDA's Orange Book for IMVEXXY, a vaginal insert designed to alleviate pain during intercourse post-menopause.
Sun Pharma stocks were trading in the green, up 2.26 per cent at ₹1656.30 on July 25, at 2:13 pm, on the BSE. The company enjoys a market capitalisation of ₹3,97,212.20 crore.
Orange Book-listed patents have been approved by the US Food and Drug Administration (FDA) and are considered safe for use.
Mayne Pharma stated that the lawsuit was prompted by a notification that Sun Pharma had submitted an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic version of IMVEXXY.
An ANDA is a request to the health regulator for approval to produce a previously licensed drug in the United States. These applications do not require the applicant to conduct clinical trials.
The complaint from Mayne Pharma also noted that Sun Pharma filed a Paragraph IV certification, challenging the validity or applicability of IMVEXXY's patents listed in the Orange Book.
This "formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Sun Pharma's ANDA," Mayne Pharma said in a statement.
IMVEXXY, which is distributed by TherapeuticsMD, received FDA approval in 2018.
Sun Pharma's legal woes
In another related development, Sun Pharma challenged the National Pharmaceutical Pricing Authority (NPPA) demand notices of 2005. The company was directed to deposit the overcharged principal amount of ₹2,15,62,077 for the April 1996 to July 2003 period and the interest on this amount ( ₹2,49,46,256) for Roscilox, a brand of a Cloxacillin-based drug formulation.
The Supreme Court has dismissed Sun Pharma's plea against a demand notice of ₹4.65 crore raised by the NPPA to recover the amount overcharged by the company for anti-bacterial infection drug Roscilox.
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