News & Analysis as of

Abbreviated New Drug Application (ANDA)

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Commissioner’s National Priority Voucher Program to Accelerate Drug Application Review Process and Support National...

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S....more

Venable LLP

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

Venable LLP on

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

Latham & Watkins LLP

FDA Color Additive Scrutiny Expands to Pharmaceuticals

Latham & Watkins LLP on

FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

DLA Piper on

In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more

Robins Kaplan LLP

Generic Launches

Robins Kaplan LLP on

Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant...more

Robins Kaplan LLP

ANDA Approvals

Robins Kaplan LLP on

New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Robins Kaplan LLP

Boehringer Ingelheim Pharms. Inc. v. Apotex Inc.

Robins Kaplan LLP on

Tradjenta® (linagliptin) - Case Name: Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., Civ. No. 23-685-CFC, 2025 WL 71979 (D. Del. Jan. 10, 2025) (Connolly, J.)  Drug Product and Patent(s)-in-Suit: Tradjenta® (linagliptin);...more

Robins Kaplan LLP

Alcon Inc. v. Padagis Israel Pharms. Ltd.

Robins Kaplan LLP on

Simbrinza® (brinzolamide / brimonidine) - Case Name: Alcon Inc. v. Padagis Israel Pharms. Ltd., Civ. No. 22-1422-WCB, 2025 WL 457119 (D. Del. Feb. 5, 2025) (Bryson, C.J.)  Drug Product and Patent(s)-in-Suit:  Simbrinza®...more

ArentFox Schiff

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

Robins Kaplan LLP

Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC

Robins Kaplan LLP on

INOMax® (nitric oxide) - Case Name: Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, Civ. No. 22-1648-RGA, 2025 WL 472557 (D. Del. Feb. 12, 2025) (Andrews, J.)  Drug Product and Patent(s)-in-Suit: INOMax® (nitric...more

McDonnell Boehnen Hulbert & Berghoff LLP

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

Knobbe Martens on

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

A&O Shearman

Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For...

A&O Shearman on

On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

MoFo Life Sciences

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

MoFo Life Sciences on

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more

Alston & Bird

Patent Case Summaries | Week Ending April 11, 2025

Alston & Bird on

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more

McDermott Will & Emery

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more

Haug Partners LLP

Defend & Deduct: How the Federal Circuit's Actavis Decision Changes Tax Implications for ANDA Filers

Haug Partners LLP on

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important practical question regarding the interplay between the Hatch-Waxman Act and the Internal Revenue Code:...more

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Foley & Lardner LLP

GLP-1 Receptor Agonists: Drug Litigation Overview and Trends

Foley & Lardner LLP on

The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

McDermott Will & Emery

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

McDermott Will & Emery on

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

Goodwin

Federal Circuit Confirms Deductibility of Hatch-Waxman Litigation Expenses

Goodwin on

On March 21, the Court of Appeals for the Federal Circuit held in a precedential opinion that legal fees incurred by generic drug companies in defending against patent infringement suits brought under the Hatch-Waxman Act...more

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