Generics

Sun Strikes Further US Price-Fixing Settlement For $200m

 
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The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
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There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

 
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The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
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At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.


US Federal Circuit Clears Path for MSN to Market Entresto Generic

 
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Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 

Generics Bulletin reviews global regulatory developments across the world.

Industry Welcomes Support From UK Life Sciences Plan

 
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A new life sciences strategy unveiled by the UK government has won plaudits from the off-patent industry for its inclusion of measures specifically geared towards generics and biosimilars – especially a £1bn savings target linked to biosimilar uptake.

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

 

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.


Adalvo Changes Hands As EQT Takes Control

 
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Private equity firm EQT is taking control of Alvo group B2B business Adalvo, after striking a deal to acquire a majority stake from Aztiq, the investment vehicle of founder Róbert Wessman.

FTC’s Latest Effort To Dispute Improper Patent Listings Barely Made A Dent

 

Trump’s FTC has carried on two legacies – trying to eliminate improper drug patent listings and making minimal impact on such efforts.

Amphastar Unveils Plans To Quadruple US Manufacturing

 
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Amphastar has announced plans to quadruple its domestic production capacity over the next three to five years. The move plays into a growing trend towards US manufacturing localization, against the backdrop of potential pharmaceutical tariffs being mooted by the Trump administration.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
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As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.


ViiV Extends Voluntary License For Long-Acting Cabotegravir As HIV Treatment

 

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.

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

 
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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.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
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The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
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As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.


Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
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Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
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At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

MSN Labs Swerves 2026 US Entresto Patent Ahead Of Separate July 15 Expiry

 
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Novartis has filed an immediate appeal after a US district court ruled that MSN Labs would not infringe one of its key patents shielding its $7.8bn Entresto brand, and denied the originator injunctive relief.

UK Sitagliptin Prices Shoot Up In June

 
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Multiple strengths of sitagliptin saw average price increases that topped our rundown of UK generic pricing data in June.