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Home » Topics » Drugs » Generic

Generic
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Ozempic and Wegovy pens and packaging

Should generics jump the queue in Wegovy parade?

Sep. 25, 2024
By Mari Serebrov
Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.
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Glenmark settles US civil price-fixing allegations

Sep. 10, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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Glenmark settles US civil price-fixing allegations

Sep. 5, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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Piggy bank filled with dollar coins

GSK, Prasco pressured to drop price of pediatric inhaler

Aug. 15, 2024
By Mari Serebrov
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
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GSK, Prasco pressured to drop price of pediatric inhaler

Aug. 14, 2024
Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.
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Fed Circuit resuscitates skinny label infringement challenge

June 26, 2024
By Mari Serebrov
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
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Generic drugs and bottle

Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t

April 10, 2024
By Mari Serebrov
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
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Magnifying glass, FDA concept image

US FDA struggling to keep up with clinical research inspections

April 4, 2024
By Mari Serebrov
The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.
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Teva, Janssen to continue squabble over schizophrenia drug patent

April 2, 2024
By Mari Serebrov
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
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US FDA: Fewer reserve drug samples needed

March 27, 2024
By Mari Serebrov
Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability and bioequivalence studies.
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