Generic Drugs The United States Food and Drug Administration

News & Analysis as of

FDA releases additional draft guidance regarding implementation of BPCIA

On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more

California Supreme Court Details Antitrust Analysis of "Reverse Payment" Patent Settlements

Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court's application of the Rule of Reason to the antitrust analysis of so-called "reverse payment"...more

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more

Acorda Therapeutics, Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.). Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more

AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation...more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

Apotex Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Biosimilars Await Naming Guidance From FDA

Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a...more

FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Direct Purchasers and End Payors Accuse Brand Pharma of Delaying Generic Entry

Americans want access to inexpensive pharmaceutical drugs. This demand must be balanced with the fact that brand-name, innovator pharmaceutical companies typically invest tremendous resources to research and develop new...more

Glenmark Generics Ltd. v. Ferring B.V.,

Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends – Part Two of Two

Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends: Part One of Two

On February 9-11, 2015, a record 765 attendees descended on Miami Beach for the Generic Pharmaceutical Association (GPhA’s) Annual Meeting. Craig Wheeler, President, Momenta Pharmaceuticals, Inc. delivered the welcoming...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Actavis Amici Briefs Don’t Support Injunction

The expedited appeal to the Second Circuit pits New York State’s arguments for facilitating competition in a “molecule market” (a product market defined by the active ingredient of a prescription drug) against the brand name...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

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