We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Teva Tries to Block Generic Copaxone with Another Citizen’s Petition

Teva Tries to Block Generic Copaxone with Another Citizen’s Petition

July 9, 2014

Teva is still fighting to keep generic versions of its blockbuster multiple sclerosis drug Copaxone off the market, with its seventh citizen’s petition asking the FDA to mandate that any ANDA on the product undergo extra levels of bioequivalence testing.

In the petition, dated July 2, the Israeli drugmaker argues that any Copaxone (glatiramer acetate) generics must undergo full-scale clinical trials and use the same gene expression markers and biological pathways in demonstrating sameness to the reference product. Doing otherwise would invite a similar but not identical generic that could be dangerous to public health, Teva says. The company said it had included new scientific data on gene expression in the petition.

Ordinary pharmacokinetic studies to determine generic equivalence aren’t enough for drugs like Copaxone that hydrolyze locally, Teva said.

The company originally had requested the testing mandate as an amendment to its NDA on Copaxone, which pulled in $4.3 billion in sales last year, but the FDA pushed back, requesting that Teva resubmit its proposal as a citizen’s petition so that others could weigh in.

In addition to the citizen’s petition, Teva has also mounted legal challenges to Copaxone generics that have gone as far as the U.S. Supreme Court. In April, Chief Justice John Roberts denied Teva’s request to put aside a lower court ruling invalidating one of Copaxone’s patents as too ambiguous. The Supreme Court is scheduled to hear full arguments on Copaxone’s ‘808 patent sometime next year.

Meanwhile, Teva also has been trying to give new life to its Copaxone exclusivity by switching patients from the 20mg version covered under the ‘808 patent to a 40mg dose.

Another legal challenge filed to protect Copaxone targeted the FDA itself: a lawsuit seeking to force the agency to require ANDA filers to meet additional requirements. That lawsuit was tossed by a federal judge in May. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.

Pharmaceuticals Commercial Operations

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • CE mark

    MiRXES Earns CE Mark for COVID-19/Flu Test

  • KitePharma_Logo

    Kite Pharma’s Tecartus Gains UK Recommendation for Lymphoma

  • Eli Lilly logo

    Lilly’s Monoclonal Antibody Could Prevent COVID-19 in the Elderly

  • CE mark

    Fluidigm Gains CE Mark for Saliva-Based Assay for COVID-19

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing