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Intellectual Property

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Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

Generic Drugs Intellectual Property

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues

Five Big Legal Stories From 2022

Generics Bulletin looks back at a selection of the most significant legal stories from 2022, including a major victory in the UK on the Eliquis blood thinner giant and continued action on generic label carve outs, which has the potential to reverberate through the US industry.

Legal Issues Intellectual Property

Ibrance Generics Arrive In India, Patient Programs Add Free Drug Component

Pfizer’s Ibrance is set to lose exclusivity in the US only by 2027, but the Indian market is buzzing with activity as generics including from top-ranked drug maker Sun Pharma vie for a share of the pie. Competing CDK4/6 inhibitors are already available but can cut-price palbociclib versions alter market dynamics?

Generic Drugs Launches

MSN Facing 2026 Wait On US Cabozantinib – Or Will It Be 2032?

In a closely-watched case, the first of two planned in less than 18 months, MSN Laboratories scooped a mixed verdict from a US district court regarding its proposed generic version of Exelixis’ Cabometyx (cabozantinib) tyrosine kinase inhibitor.

Generic Drugs Legal Issues

Entresto Patent Order Quashed In India, Market Ripe For Action

Court sets aside order pertaining to patent for Novartis’s Entresto in India, setting the stage for high-octane generic competition that potentially includes frontline domestic companies. If the Swiss firm appeals, market dynamics may be impacted but prices of same-composition second brands of the heart-failure therapy are already headed southwards.

Intellectual Property Legal Issues

Teva, Cipla, Lupin, Among Firms Sued Over Landmark Cannabidiol Drug

Jazz Pharmaceuticals’ GW Pharma arm has brought a patent infringement suit against more than a dozen proposed ANDA sponsors targeting generic versions of its marijuana-derived Epidiolex (cannabidiol) to treat rare and severe childhood-onset epilepsies.

Cannabidiol CBD Intellectual Property

Sandoz US Pirfenidone Gamble Pays Off With Federal Circuit Victory

The US Court of Appeals for the Federal Circuit has comprehensively rejected Genentech’s patent-litigation appeal against Sandoz over the ANDA sponsor’s generic version of its Esbriet treatment for idiopathic pulmonary fibrosis.

Legal Issues Intellectual Property

Novartis Settles US Exforge Case For $245m

Novartis has agreed to pay out $245m to purchasers and retailers to resolve a lawsuit accusing the originator of an unlawful deal with Par that delayed US competition to the Exforge antihypertensive.

Legal Issues Intellectual Property
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