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Brand-Generic Pay-For-Delay Deals May Become Extinct, FTC Finds

 
• By Brenda Sandburg

Only one of 232 brand-generic patent suit settlements in the US during FY 2016 contained a side deal or commitment not to market an authorized generic.  

3D rendering of Tyrannosaurus Rex near extinction. - Illustration
Will pay-for-delay deals between brand and generic companies go the way of T. Rex? • Source: Shutterstock

The US Federal Trade Commission found that only one patent settlement agreement between brand and generic companies in fiscal year 2016 contained a side deal or commitment not to market an authorized generic, suggesting that so-called pay-for-delay deals may become a thing of the past.

In its latest report on brand-generic patent settlements, released on 23 May, the FTC does not use the term...

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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

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• By Dean Rudge

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US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

More from Biosimilars & Generics

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.