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Competition Prescription Drugs

Venable LLP

Accord Announces Launch of Stelara® (ustekinumab) Biosimilar Imuldosa®

Venable LLP on

On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Imuldosa® is approved for all the reference product’s...more

Sheppard Mullin Richter & Hampton LLP

DOJ and FTC Host Second Session on Structural and Regulatory Impediments to Drug Competition

On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

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On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

A&O Shearman on

On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

Morrison & Foerster LLP

Trump Antitrust Enforcers Take Aim at High Drug Costs, With Uncertain Path Forward

Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

Polsinelli on

Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....more

Goodwin

DOJ and FTC Host ‘Listening Sessions’ on Competition Issues in the Pharmaceutical Industry

Goodwin on

In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more

Haug Partners LLP

Regeneron Pharmaceuticals, Inc. v. Amgen Inc.: Jury Finds Rebate Offers on Bundled Drugs in Exchange for Exclusive Formulary...

Haug Partners LLP on

On May 15, 2025, a federal jury in Delaware district court determined that Defendant Amgen Inc. (“Amgen”) violated antitrust and tort laws, and awarded $406.8 million in damages to Plaintiff Regeneron Pharmaceuticals, Inc....more

Rivkin Radler LLP

Cigna Sues Bristol Myers Squibb Alleging Scheme to Block Generic Drug

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Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Mintz - Health Care Viewpoints

Arkansas Law Takes Unprecedented Step to Prohibit PBM Ownership of Pharmacies

On April 16, 2025, Arkansas Governor Sarah Huckabee Sanders signed into law House Bill 1150, now Act 624 (the Act), making Arkansas the first state in the nation to prohibit pharmacy benefit managers (PBMs) from acquiring or...more

Kerr Russell

Michigan AG Alleges Anticompetitive Agreement Between Pharmacy Benefit Managers

Kerr Russell on

Michigan Attorney General Dana Nessel sued Express Scripts Inc. and Prime Therapeutics LLC, two pharmacy benefit managers (PBMs), in the U.S. District Court for the Eastern District of Michigan on Monday, April 28, 2025....more

Maynard Nexsen

Prescription Revolution: Trump’s Bold Move to Slash Drug Prices

Maynard Nexsen on

An Overview of the Executive Order on Lowering Drug Prices - On April 15, 2025, President Donald J. Trump signed an Executive Order aimed at reducing prescription drug prices in the United States. This order builds upon...more

Proskauer Rose LLP

Question of the Week: How are expiring patents fueling M&A in the life sciences industry?

Proskauer Rose LLP on

Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more

Knobbe Martens

Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”

Knobbe Martens on

On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more

McDermott Will & Schulte

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

A&O Shearman

Eastern District Of Pennsylvania Grants Defendants’ Motion To Dismiss Allegations Of Tying Discounted Drug Prices With Third-Party...

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On February 26, 2025, Judge Mia Perez of the United States District Court for the Eastern District of Pennsylvania granted defendants’ motion to dismiss plaintiff’s Sherman Act and Clayton Act claims, though the plaintiff had...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Wilson Sonsini Goodrich & Rosati

Navigating Pharmaceutical Patent Settlements and Reverse Payments: Key Takeaways from the FTC’s Latest MMA Reports

On January 16, 2025, the Federal Trade Commission (FTC) Bureau of Competition published four reports on pharmaceutical patent settlement agreements filed under the Medicare Prescription Drug, Improvement, and Modernization...more

McCarter & English, LLP

FTC Issues PBM Report Signaling Consolidation Is Impacting Pharmaceutical Prices

At a public meeting held on January 15, 2025, the Federal Trade Commission (FTC) summarized the Second Interim Staff Report (Second Report) stemming from its investigation into pharmacy benefit managers (PBMs) and their...more

Troutman Pepper Locke

West Virginia AG Reaches $17M Settlement With Pfizer and Ranbaxy Over Antitrust and Consumer Protection Violation Claims

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West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more

A&O Shearman

District Court Of Connecticut Largely Denies Generic Drug Manufacturers’ “Unusual” Dismissal Motion Targeting Specific Types Of...

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On November 12, 2024, Judge Michael P. Shea of the United States District Court for the District of Connecticut granted in part and denied in part a joint motion to dismiss submitted by thirty-six defendant drug manufacturers...more

Fenwick & West LLP

Heart of Healthcare Podcast: FTC Chair Lina Khan on Healthcare, Antitrust, and the Future of Competition

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In a recent episode of the Heart of Healthcare podcast, co-hosts Michael T. Esquivel and Halle Tecco, sat down with Federal Trade Commission (FTC) Chair Lina Khan, who offered her perspective on the intersection of antitrust...more

Stevens & Lee

FTC Files Suit Against the Three Largest Pharmacy Benefit Managers

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The Federal Trade Commission (FTC) recently sued the three largest pharmacy benefit managers (PBMs) – Caremark Rx, Express Scripts (ESI) and OptumRx – alleging that the PBMs and their related group purchasing organizations...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

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