Exclusivity from the Experts

One of the breakout sessions offered at the recent FDLI conference was titled, Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs and Biologics.  The panel for this session included representatives from FDA, industry, and attorneys that specialize in this practice area.  While the session covered both patent and exclusivity issues, I will be […]

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80 Products Approved with CGT Designation Thus Far

The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here).  CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]

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Skinny Label Reprieve, But Not Out of the Woods Yet!

The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label.  Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case.  Clearly, Congressional intent and regulatory […]

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Kick, Fight, and Scream, but Most of All Hope the Full Appeals Court (and/or the Supreme Court) Reverses

Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance.  Rather […]

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Competitive Generic Therapy Approvals Listed by FDA

The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]

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Pregabalin Approvals Hit the Approval Trail, but Why So Late?

According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019.  However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019.  This got my mind working to try to figure out why the 17-day (June 30 fell […]

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