ANDA The United States Food and Drug Administration

News & Analysis as of

Purdue Pharma L.P. v. Amneal Pharms., LLC

Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) - Drug Product and Patent(s)-in-Suit: OxyContin®...more

GlaxoSmithKline LLC. v. Glenmark Generics Inc.

Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more

Otsuka Pharmaceutical Co., Ltd. v. Burwell

Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) - Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A - Nature...more

Amarin Pharms. Ireland Ltd v. FDA

Case Name: Amarin Pharms. Ireland Ltd v. FDA, Case No. 14-cv-00324 (RDM), 2015 U.S. Dist. LEXIS 68723 (D.D.C. May 28, 2015) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® Capsules (icosapent ethyl); N/A...more

Braintree Labs., Inc. v. Novel Labs., Inc.

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more

FDA Regulatory and Compliance Monthly Recap – July 2015

FDA finalizes guidance on analytical procedures and methods validation - The regulator issued recommendations to help applicants submit analytical procedures and methods validation data to “support the documentation of...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) - Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A - Nature of...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

The Medicines Company v. Hospira (Fed. Cir. 2015)

There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more

Allergan Fights Back, Files Complaint Against Venture Fund That Filed IPR Petition

Last month, Allergan, Inc. and Allergan Sales, LLC filed suit against Ferrum Ferro Capital, LLC and Kevin Barnes ("FFC") in the U.S. District Court for the Central District of California, alleging that FFC attempted to extort...more

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

District Court Decision Opens Door to Five-Year NCE Exclusivity for Single Components of Previously FDA-Approved Multi-Component...

On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...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

Ranbaxy Labs., Ltd. v. Burwell

Case Name: Ranbaxy Labs., Ltd. v. Burwell, 14-cv-1923 BAH, 2015 U.S. Dist. LEXIS 29459 (D.D.C. Mar. 11, 2015) (Howell, J.). Drug Products and Patents-in-Suit: Nexium® (esomeprazole) and Valcyte® (valganciclovir);...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’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

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