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Generics Bulletin Explains: The Changing US Generics Market

Price Pressures Are Abating Amid Portfolio Pruning, Market Exits And Shortages

 
• By Dave Wallace

After a couple of years of heavy downwards pressure on US generics prices, prominent off-patent companies have pointed to a change in the pricing environment as several factors combine to reduce price erosion. Meanwhile, some firms are benefiting from first generic launches as others exit the market altogether, while injectables shortages continue to loom large.

Dollar coin squeezed in G-clamp on top of USA flag
Pricing pressures on generic drugs are easing in the US • Source: Shutterstock

Robert Califf, commissioner of the US Food and Drug Administration, recently summarized in straightforward terms the disconnect between the public perception of high drug prices and the realities for the off-patent industry by stating that innovator prices “are too high,” while for the generics industry “a lot of the prices are too low.”

“What I mean by that,” Califf explained, in widely reported comments made at an Alliance for a Stronger FDA event,...

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

 
• By Dave Wallace

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

 
• By Dean Rudge

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

 
• By Dave Wallace

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.

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

 
• By Dave Wallace

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

 
• By Dean Rudge

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

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.