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The End of an Era: Lipitor, Blockbuster Drugs and the Waxman/Hatch Model

 
• By Michael McCaughan

Pfizer’s Lipitor goes generic—albeit with some decidedly unusual wrinkles. The biggest generic launch in history is a good moment to take stock of the transition away from the blockbuster model. The reaction to the milestone suggests that the industry’s critics may be having a harder time letting go of the old model than industry is.

If you want to pick a date to mark the end of the blockbuster drug era, December 1, 2011 is probably the right choice.

That is the day when Ranbaxy Pharmaceuticals Inc. launched the first “true” generic version of Pfizer Inc.’s cholesterol lowering drug Lipitor (atorvastatin). A generic actually became available the...

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More from Legal & IP

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

More from Pink Sheet

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.