News & Analysis as of

ANDA The United States Food and Drug Administration

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more

FDA Announces “New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices”

by Locke Lord LLP on

The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

FDA Includes Patent Submission Date Updates In Orange Book

by Tarter Krinsky & Drogin LLP on

The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more

Hatch-Waxman Venue: The New Narrow?

by Robins Kaplan LLP on

The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more

New FDA Guidance On Determining Whether To Submit An ANDA Or A 505(b)(2) Application

The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications. Both sections were added to the FD&C Act...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application. The purpose...more

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman

by McDermott Will & Emery on

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more

Millennium Pharms., Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762, 2016 U.S. App. LEXIS 12702 (Fed. Cir. July 17, 2017) (Circuit Judges Newman, Mayer, and O’Malley...more

Frequent Participation in Hatch-Waxman Litigation in a Forum May Be Relevant to Whether a Defendant Can Be Sued in That Forum for...

Submitting an Abbreviated New Drug Application (ANDA) and subsequent prospective infringement can be sufficient to show an act of infringement under the venue statute. And frequent participation in Hatch-Waxman litigation in...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

by Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual 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

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

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

by Foley & Lardner LLP on

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

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