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Intellectual Property

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Apotex Moves First On Combigan As US Patent Expiry Looms

Apotex has moved first on Allergan’s Combigan, introducing a US authorized generic as the clock ticks on the originator’s IP. Sandoz is among ANDA sponsors seemingly waiting for patent protection to lapse.

Launches Intellectual Property

Does Hikma’s Vascepa Litigation Dismissal Suggest Safety For Skinny Labels?

An induced-infringement attack on Hikma’s skinny-label generic version of Vascepa had been cited as evidence of the potential harm that would be caused by controversial rulings in separate litigation involving GSK and Teva. However, these fears may now appear overstated after the claim against Hikma was dismissed.

Legal Issues Intellectual Property

Alvotech Eyes Canada Humira Launch As Celltrion Also Bags High-Strength Approval

The first biosimilar approval stemming from Alvotech’s collaboration with JAMP Pharma in Canada has arrived, with the firms’ Simlandi (adalimumab) biosimilar version of AbbVie’s higher-strength Humira. Celltrion has also announced an approval from Health Canada.

Approvals Strategy

Induced Infringement And Price Fixing Among Legal Headlines In 2021

In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.

Legal Issues Intellectual Property

Hikma Triumphs As Vascepa Induced-Infringement Case Dismissed

An attack on Hikma’s skinny-label generic version of Vascepa by originator Amarin, claiming induced infringement of patents protecting a cardiovascular indication, has been dismissed in the US.

Intellectual Property Legal Issues

Is CREATES Act Equipped To Handle Biosimilar Complaints?

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Biosimilars Legal Issues

US Federal Circuit Breathes Life Into Viatris Symbicort Challenge

Viatris may be able to move earlier than anticipated with its Breyna proposed generic version of Symbicort, after the US Court of Appeals for the Federal Circuit found that a lower court had misinterpreted claims of Symbicort patents for which Viatris has stipulated to infringement.

Legal Issues Intellectual Property

Novartis Fends Off US Fingolimod Competition – For Now

The latest decision in US litigation with HEC Pharma over multiple sclerosis treatment Gilenya means that generics will be kept off the market for at least two years, according to originator Novartis.

Intellectual Property Legal Issues

Viatris And Sandoz May Market Injectafer Generic In US From 2026

After over two years of litigation, Vifor and American Regent have reached agreements with Viatris’ Mylan and Sandoz regarding their generic ferric carboxymaltose products, allowing both companies to bring rivals to market ahead of the expiry of certain US patents.

Generic Drugs Legal Issues
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