By Kurt R. Karst – The first iteration of the Generic Drug User Fee Amendments (“GDUFA”) – “GDUFA I” – is now well into Year 4 of the 5-year program, and anticipation is growing as to what the second iteration of the program – “GDUFA II” …
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Hatch-Waxman
- RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish ListMay 18th, 2016
- Speculating About the Prospects of Exclusivity – A Potentially Risky GameMay 5th, 2016
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, 7-year orphan drug exclusivity, or any other type of exclusivity or add-on exclusivity – upon the …
- The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid DevelopmentMay 2nd, 2016
By Kurt R. Karst – On April 29, 2016, Represetatives Gerry Connolly (D-VA) and Morgan Griffith (R-VA) announced the introduction of H.R. 5127, the “Curb Opioid Misuse by Advancing Technology (COMBAT) Act.” The COMBAT Act is the latest effort by Congress to incentivize the development of …
- Tested Mettle: Vifor Fresenius Petitions FDA to Make a Decision on NCE Exclusivity for Iron-based Phosphate Binder VELPHOROApril 27th, 2016
By Kurt R. Karst – Disputes involving non-patent marketing exclusivity available to 505(b)(1) and 505(b)(2) NDA applicants – either 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, or 7-year orphan drug exclusivity – have increased dramatically over the past few years, and there’s …
- The FTC’s “Pay-for-Delay” Lawsuit Against Endo: Is There a Hole in the Commission’s Generic LIDODERM 180-Day Exclusivity Analysis?April 19th, 2016
By Kurt R. Karst – Last month, the Federal Trade Commission (“FTC”) announced the filing of a Complaint For Injunctive and Other Equitable Relief in the U.S. District Court for the Eastern District of Pennsylvania alleging that Endo Pharmaceuticals Inc. (“Endo”) and other drug manufacturers, including …
- Webinar: Avoiding Drug Substance Patents and Exclusivities – Prodrugs, Deuterated Drugs, and 505(b)(2) ApplicationsApril 4th, 2016
For generic drug companies, the biggest and most expensive challenge to a US product launch is the patent that covers the Active Pharmaceutical Ingredient (“API”). Notoriously, only one such patent has ever been invalidated for obviousness. On Thursday, April 14, 2016, from 9:00 AM – 10:00 …
- FDA Proposes a Tier-Based Approach to Evaluate “Bioequivalence” of Abuse Deterrence of Generic SODF OpioidsMarch 24th, 2016
By Kurt R. Karst – Ever since FDA Commissioner Dr. Robert M. Califf's February 2016 call for a sweeping review of FDA policies concerning opioids (in response to growing pressure from Congress), the Agency has been on a tear to meet that call with new policies and requirements. There's the recent announcement …
- Not a Blowout: DC District Court Upholds FDA’s Pre-2014 Interpretation on NCE Exclusivity for Combos, But Wants Additional Briefing on Retroactivity of Post-2014 InterpretationMarch 16th, 2016
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Columbia (Judge Rudolph Contreras) issued a 33-page Memorandum Opinion in a case stemming from a Complaint filed in June 2015 by Ferring Pharmaceuticals Inc. (“Ferring”) against FDA challenging the Agency’s …
- Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug ReviewsMarch 3rd, 2016
By Kurt R. Karst – The ongoing controversy over drug pricing has raised debate on many aspects of drug approval, and, in particular, on the approval of generic drugs. Over the past several months, there have been numerous letters from Members of Congress to FDA – …
- Just the Facts, Ma’am: OGD Director Uhl Provides the Lowdown on GDUFA ImplementationFebruary 25th, 2016
By Kurt R. Karst – Earlier this week at the Generic Pharmaceutical Association’s (“GPhA”) annual meeting in Orlando, Florida, Dr. Kathleen (“Cook”) Uhl, Director of the Office of Generic Drugs (“OGD”), gave the keynote address, providing the generic drug industry with a much-anticipated lowdown on FDA’s …
- An Oldie, But a Goodie: Revisiting a Not-Quite-Yet Vestigial Remnant of a Pre-MMA EraFebruary 15th, 2016
By Kurt R. Karst – Question: When was the first time FDA approved an ANDA containing a Paragraph IV certification to a patent listed in the Orange Book for DIPRIVAN (propofol) Injection, 10 mg/mL, approved under NDA 019627, and granted a period of 180-day exclusivity? Buehler, Buehler? If …
- NDA Approval Date Resets: More Than a One-offFebruary 11th, 2016
By Kurt R. Karst – We love precedents – particularly unusual precedents that are wrapped up in drug approval histories. A couple of years ago we learned about a new precedent concerning the “date of approval” of a drug product. That term is defined in an …
- Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA PatentFebruary 8th, 2016
By Kurt R. Karst – The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the …
- FDA’s Orange Book Preface Gets a Facelift: What’s New?February 3rd, 2016
By Kurt R. Karst – Those folks who have been following this blog for several years have a good sense about the depths of this blogger’s passion for the Orange Book. There’s the license plate (“ORNGBUK”), the trip to the summit of Mt. Kilimanjaro with the …
- Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation DismissedJanuary 27th, 2016
By Kurt R. Karst – Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA …