News & Analysis as of

Generic Drugs The United States Food and Drug Administration

Alza Corp. v. Amneal Pharmaceuticals of New York, LLC

by Robins Kaplan LLP on

Case Name: Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 53551 (D. Del. Apr. 7, 2017) (Andrews, J.)....more

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., 2017 U.S. Dist. LEXIS 62020 (D.N.J. Apr. 24 2017) (Walls, J.)....more

Teva Pharms. USA, Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more

GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more

Federal Circuit upholds Millennium’s Patent on Velcade®

by Knobbe Martens on

MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Sebela Int’l Ltd. v. Actavis Labs. Florida Inc.

by Robins Kaplan LLP on

Case Name: Sebela Int’l Ltd. v. Actavis Labs. Florida Inc., No. 14:6414 (CCC) (MF), 2017 U.S. Dist. LEXIS (D.N.J. June 16, 2017) (Cecchi, J.)....more

Forest Labs., LLC v. Sigmapharm Labs., LLC

by Robins Kaplan LLP on

Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 101653 (D. Del. June 30, 2017) (Robinson, J.)....more

The Medicines Co. v. Mylan Inc.

by Robins Kaplan LLP on

Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

Braintree Labs., Inc. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (Circuit Judges Newman, Moore, and Wallach presiding; Opinion by Moore, J.) (appeal from S.D.N.Y., Nathan, J.)....more

Mylan Institutional LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Pharma Ltd., 2017-1645, 2017 U.S. App. LEXIS 8792 (Fed. Cir. May 19, 2017) (Circuit Judges Lourie, Moore, and Reyna presiding; Opinion by Lourie, J.) (appeal from E.D. Tex.,...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

A Meeting, a MaPP, and Two Lists: Initial Elements of the Commissioner’s Drug Competition Action Plan Rolled Out

FDA has been busy recently in areas tied to drug pricing. In the last half of June, FDA issued a public meeting notice, a revised Manual of Policy and Procedures (MaPP), and two lists of approved drugs for which a generic has...more

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As...more

FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan

by Latham & Watkins LLP on

Agency works to speed approvals and improve access to generic prescription drugs. In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

by Dorsey & Whitney LLP on

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

FDA Commissioner Hints at Drug Pricing-Related Initiatives

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was...more

New FDA Commissioner Hits the Ground Running

by Foley & Lardner LLP on

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and...more

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

In re copaxone consolidated cases

by Robins Kaplan LLP on

Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.). Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents...more

Apotex Inc. v. Alcon Research, Ltd.

by Robins Kaplan LLP on

Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more

Reckitt Benckiser LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

Case Name: Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civ. No. 14-1203-LPS, 2017 U.S. Dist. LEXIS 31985 (D. Del. Mar. 6, 2017) (Stark, J.). Drug Product and Patent(s)-in-Suit: Mucinex® DM (dextromethorphan...more

Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more

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