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FDA files motion to dismiss Teva suit on exclusivity loss for generic Cozaar

 
• By Nancy Faigen

The US FDA has filed a motion to dismiss Teva Pharmaceutical Industries' recent lawsuit regarding the loss of its first-filer marketing exclusivity on generic versions of Merck & Co's antihypertensives, Cozaar (losartan potassium) and Hyzaar (losartan plus hydrochlorothiazide).

The US FDA has filed a motion to dismiss Teva Pharmaceutical Industries' recent lawsuit regarding the loss of its first-filer marketing exclusivity on generic versions of Merck & Co's antihypertensives, Cozaar (losartan potassium) and Hyzaar (losartan plus hydrochlorothiazide).

Teva has pending ANDAs for its generic versions, and the case involves a situation where a brand firm has voluntarily...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Pipeline Watch: Seven Approvals And Five Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Indegene Exec On DTP Distribution As A ‘Tactical Solution’, Feasibility Of MFN Model

 
• By Anju Ghangurde

Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US and underlines that it isn’t a comprehensive healthcare fix. The feasibility of MFN pricing and why it may be “catastrophic” to the industry were some of the other topics discussed.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion.