Generic Drugs The United States Food and Drug Administration

News & Analysis as of

Cumberland Pharms., Inc., v. Mylan Institutional LLC

Case Name: Cumberland Pharms., Inc., v. Mylan Institutional LLC, Civ. No. 12-C-3846, 2015 U.S. Dist. LEXIS 134495 (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.)... Drug Product and Patent(s)-in-Suit: Acetadote®...more

Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civ. No. 11-3962, 2015 U.S. Dist. LEXIS 167048 (D.N.J. Nov. 13, 2015) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S. Patents...more

Spectrum Pharms., Inc. v. Sandoz, Inc.

Case Name: Spectrum Pharms., Inc. v. Sandoz, Inc., 2015-1407, 2015 U.S. App. LEXIS 17313 (Fed. Cir. Oct. 2, 2015) (Circuit Judges Lourie, Wallach, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D. Nev., Navarro,...more

Prometheus Labs., Inc. v. Roxane Labs., Inc.

Case Name: Prometheus Labs., Inc. v. Roxane Labs., Inc., 2014-1634, -1635, 2015 U.S. App. LEXIS 19556 (Fed. Cir. Nov. 10, 2015) (Circuit Judges Dyk, Taranto, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D.N.J.,...more

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

“Destroying Things Is Much Easier Than Making Them” – The Worst Prescription Drug/Medical Device Decisions of 2015

In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.” That’s how we feel about our bottom ten...more

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

When They Don’t Have Anything, They’ll Try Anything

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). A couple of anonymous, obviously plaintiff-side,...more

Breaking News - FDA Generic Drug Anti-Preemption Proposal Again

We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called "Supplemental Applications Proposing Labeling Changes for Approved Drugs and...more

New Law Remedies Partial Loss of Drug Marketing Exclusivity Period Caused by U.S. DEA Scheduling Delays

When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...more

Generic Preemption Prevails in Testosterone MDL

What? You were expecting another of our insensitive blogpost headlines? Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Health Care Update - October 2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more

Allergan, Inc., v. Sandoz Inc.

Case Name: Allergan, Inc., v. Sandoz Inc., Civ. No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Circuit Judges Lourie, Linn, and Hughes presiding; Opinion by Lourie, J.) (Appeal from E.D. Tex., Schneider,...more

Shire LLC v. Amneal Pharms. LLC

Case Name: Shire LLC v. Amneal Pharms. LLC, 2014-1736, -1737, -1738, -1739, -1740, -1741, 2015 U.S. App. LEXIS 16908 (Fed. Cir. Sept. 24, 2015) (Circuit Judges Moore, Mayer, and Linn presiding; Opinion by Linn, J.) (Appeal...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

3D-Printed Prescription Drugs a Huge Stride Forward for Personalized Medicine

Advances in 3D printing (3DP) technology have paved the way for pharmaceutical companies to print prescription drugs. Aprecia Pharmaceuticals recently announced that the FDA has granted it approval to manufacture Spritam®...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

District Court Denies Motion to Dismiss for Lack of Personal Jurisdiction Where Plaintiff Sent ANDA Notice Letter

Defendants, Nang Kuang Pharmaceutical Co., Ltd. ("Nang Kuang") and CANDA NX-2, LLC ("CANDA") (collectively, "Defendants") filed a motion to dismiss, asserting that the patent infringement action filed by Plaintiffs, Eli Lilly...more

Sandoz’s Zarxio® Launches with 15% Wholesale Discount

On September 3, 2015, Sandoz Inc. (“Sandoz”) announced that it launched the first biosimilar in the United States, Zarxio® (filgrastim-sndz). Sandoz began marketing Zarxio® following a Federal Circuit Order to permit it to...more

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