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Competition Generic Drugs

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...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

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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

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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

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

Proskauer Rose LLP

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

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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

Cozen O'Connor

AbbVie and Besins Healthcare Settle Oregon Antitrust Allegations Over Testosterone Drug

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Oregon AG Dan Rayfield settled with AbbVie Inc. and Besins Healthcare, Inc. to resolve allegations that the pharmaceutical companies engaged in anti-competitive conduct relating to the sale of testosterone replacement gel in...more

Haug Partners LLP

Bayer “Fleas” New Antitrust Trial – Jury’s Rejection of Flea and Tick Medication Market Upheld

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On January 21, a Northern District of California Court denied Plaintiff Tevra Brands LLC’s (“Tevra’s”) Motion for a New Trial, after a Jury found that Defendant Bayer Healthcare LLC (“Bayer”) did not monopolize the relevant...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

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

WilmerHale

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

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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

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

Patterson Belknap Webb & Tyler LLP

Jury Rejects Tevra's Embattled Market Definition in Antitrust Suit

On August 1, 2024, following five years of litigation, Tevra’s antitrust suit against Bayer Healthcare LLC came to an end. Tevra, a manufacturer of generic version topical flea and tick medications, alleged that Bayer engaged...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

Foley Hoag LLP

FTC Challenges More Patent Listings in the FDA’s Orange Book

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The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

Troutman Pepper Locke

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

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The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

Knobbe Martens

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

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The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Axinn, Veltrop & Harkrider LLP

Thankful for Pharmaceuticals . . . Especially When There are Shortages

5 When our children were young, we started a tradition at Thanksgiving of going around the table and having each of us (around 20 with extended family) saying what we were thankful for. Of course, you hear a lot of being...more

Morrison & Foerster LLP

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

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In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

Axinn, Veltrop & Harkrider LLP

FTC Takes Up the Battle Against Improper Orange Book Patent Listings

Attempting to put some teeth into the policy statement that it issued last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA's Orange Book for a variety of...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

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The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

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The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

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