News & Analysis as of

Pharmaceutical Industry › Abbreviated New Drug Application (ANDA) › Competition

Rothwell, Figg, Ernst & Manbeck, P.C.

Breaking the Patent Thicket: Why the Proposed ETHIC Act Could Have Big Implications on Pharma Patent Law

Rothwell, Figg, Ernst & Manbeck, P.C. on

On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed...more

WilmerHale

USA: Unpacking the shift – Heightened antitrust scrutiny on Orange Book listings

WilmerHale on

Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more

Arnall Golden Gregory LLP

FDA Issues Final Guidance on “505(q)” Citizen Petitions, including Factors to be considered in Evaluating Potential...

Arnall Golden Gregory LLP on

FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Competitive Generic Therapies (CGTs) Statement and Guidance Regarding CGT Designation, Approval Pathway, and Market...

Wilson Sonsini Goodrich & Rosati on

Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more

Cozen O'Connor

Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions

Cozen O'Connor on

The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often accuse brands of improperly trying to extend their monopolies over patented...more

Mintz

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

Mintz on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Oral Argument in FTC v. Actavis

McDonnell Boehnen Hulbert & Berghoff LLP on

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

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