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Competition › Abbreviated New Drug Application (ANDA) › Drug Pricing

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

Foley & Lardner LLP

How is Patent Term Extension Calculated For a Reissued Patent?

Foley & Lardner LLP on

Share on Twitter Print Share Back to top The Patent Term Extension (PTE) provisions of 35 U.S.C. 256 were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. PTE partially compensates...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

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

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