News & Analysis as of

Generic Drugs Enforcement Actions

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

Jones Day on

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

The Volkov Law Group

DOJ Settles Criminal Antitrust Charges with Teva and Glenmark for $305 Million

The Volkov Law Group on

The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed.  Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Goodwin

Antitrust + Competition Life Sciences Quarterly Update - Q1 2022

Goodwin on

Despite the aggressive rhetoric, the change in the leadership and composition at the U.S. Federal Trade Commission (FTC) did not result in more enforcement in 2021. As the calendar turned to 2022, the FTC seems to be stepping...more

The Volkov Law Group

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

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The healthcare industry faces cascading risks – one risk flows to another with compounding financial results.  Three generic drug companies just experienced this cascading liability. ...more

Cadwalader, Wickersham & Taft LLP

State Attorney General Insider – Winter 2020-2021 | December 2020 | Issue No. 3: Notable Cases

Notable Cases - Here are a few of the major cases of interest within the state Attorneys General community that are receiving significant press coverage. ...more

Cadwalader, Wickersham & Taft LLP

State Attorney General Insider – Winter 2020-2021, Issue No. 3: Notable Cases

Notable Cases - Here are a few of the major cases of interest within the state Attorneys General community that are receiving significant press coverage. ...more

Epstein Becker & Green

Key Considerations for Reshoring U.S. Drug Manufacturing

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This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more

Robins Kaplan LLP

Financial Daily Dose 9.15.2020 | Top Story: Citi Faces Federal Risk-Management Inquiry, Resumes Job Cuts

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Federal authorities are prepping to “reprimand Citigroup Inc. for failing to improve its risk-management systems—an expansive set of technology and procedures designed to detect problematic transactions, risky trades and...more

The Volkov Law Group

Teva Pharma Charged with Antitrust Conspiracy in Generic Pharmaceuticals Industry

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Teva, the global pharmaceutical giant, was indicted last week as part of DOJ’s expanding criminal conspiracy investigation focused on illegal price-fixing and customer allocations....more

The Volkov Law Group

DOJ Criminal Generic Pharma Price-Fixing Investigation Gathers Steam: Taro Pharmaceuticals Agrees to Pay DOJ Total of $419 Million

The Volkov Law Group on

The DOJ Antitrust Division’s multi-year criminal cartel investigation of the generic pharmaceutical industry is gaining steam.  The latest company to settle is Taro Pharmaceuticals which agreed to enter a deferred prosecution...more

The Volkov Law Group

DOJ Catches Big Fish in Generic Pharmaceutical Criminal Antitrust Investigation

The Volkov Law Group on

The Justice Department’s Antitrust Division announced a major guilty plea with Sandoz, Inc., in its expanding criminal investigation of the generic pharmaceutical industry....more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

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Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

McDermott Will & Emery

Cartel Snapshot - February 2019

McDermott Will & Emery on

Q4 Update: Overview of Cartel Investigations - Although 2018 saw guilty pleas and new indictments in several ongoing Department of Justice (DOJ) investigations, the year finished by continuing a downward trend in antitrust...more

Knobbe Martens

The Federal Circuit Finds Tribal Sovereign Immunity does not Apply in IPR

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On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned patents that it had asserted in litigation against various generic...more

Knobbe Martens

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

Knobbe Martens on

Federal Circuit Summary - Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Mintz - Health Care Viewpoints

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Cadwalader, Wickersham & Taft LLP

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Foley & Lardner LLP

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

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With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

The Volkov Law Group

Drug Companies and Charitable Patient Foundations

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Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

Dechert LLP

The FTC Requires Largest-Ever Generic Drug Divestiture

Dechert LLP on

The U.S. Federal Trade Commission (FTC) recently announced a settlement resolving its competitive concerns over the merger of two leading generic drug manufacturers – Teva and Allergan. In July 2015, Teva agreed to acquire...more

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