All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Controlled-Release Formulations a Popular Strategy for Generic-Drug Companies

September 10, 2009
By Pharmaceutical Technology Editors
News
Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009. Interest in these formulations is partly inspired by the number of controlled-release drugs that will soon lose patent protection.
 
The report, titled “Emerging Opportunities in Controlled-Release Generic Drugs,” says that several factors make developing controlled-release drugs an attractive strategy for generics companies. Technical hurdles make these formulations difficult to develop, and the companies that create and market them have fewer competitors and can charge higher prices than those charged for instant-release formulations. The controlled-release drugs examined in the report had combined sales of more than $15 billion in 2008.
 
Companies are beginning to consider controlled-release delivery early in the product life cycle, rather than developing it as a product’s patent expiration nears, according to the report. Some companies are marketing immediate- and controlled-release versions of new drugs simultaneously.
 
Although many controlled-release formulations are protected by patents, US companies frequently file Paragraph IV certifications under the Hatch–Waxman Act, and the patents’ validity is often the subject of litigation. Litigation sometimes yields agreements between generic-drug companies and innovators that allow the limited introduction of a generic drug before the reference product’s patent expires. The agreements can benefit innovator companies by limiting generic competition and revenue loss. The agreements can provide generic-drug companies with early market entry and a period of reduced competition.
 
Wyeth’s (Madison, NJ) popular Effexor XR (venlafaxine) has been the subject of much recent patent litigation. The company initiated several lawsuits after various firms filed abbreviated new drug applications (ANDAs) with the US Food and Drug Administration for generic versions of Effexor XR. Cases against Sandoz (Holzkirchen, Germany), Mylan (Canonsburg, PA), Wockhardt (Mumbai), Biovail (Mississauga, Canada), Torrent (Ahmedabad, India), and Apotex (Toronto) remained outstanding as of July 2009. Impax (Hayward, CA) and Mylan received tentative approval for their ANDAs for generic, controlled-release venlafaxine capsules.
 
FDA approved Osmotica’s (Wilmington, NC) new drug application for a controlled-release venlafaxine tablet. Wyeth filed a patent-infringement lawsuit against the company and ultimately granted Osmotica a license to manufacture the drug in exchange for a royalty on sales. Wyeth also settled litigation against Impax, Lupin (Mumbai), Anchen Pharmaceuticals (Irvine, CA), and Teva Pharmaceutical Industries (Petach Tikva, Israel).
 
See related PharmTech articles:

Down the Track: Different Speeds with Multiple APIs (Pharmaceutical Technology)

A Tale of Two Techniques (online exclusive)

Implications of the Pending Pfizer-Wyeth Mega Merger (PharmTech Sourcing and Management)

 

Recent Videos
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content

Teva Pharmaceuticals manufacturing site. Locally, Teva produces oral solid medicines and packaging. | Image Credit: © jetcityimage - stock.adobe.com

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

Patrick Lavery
May 30th 2025
Article

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

Companies Reveal Their Next Moves in Manufacturing

Patrick Lavery
May 29th 2025
Article

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Digital Transformation in Pharmaceutical Manufacturing

Israel Ortíz
May 28th 2025
Article

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.


An antiviral used to treat hepatitis B and C | Image Credit © luchschenF

pharma& Secures MHRA Approval for Pegasys API Production at Loba Biotech

Christopher Cole
May 28th 2025
Article

MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.

Related Content

Teva Pharmaceuticals manufacturing site. Locally, Teva produces oral solid medicines and packaging. | Image Credit: © jetcityimage - stock.adobe.com

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

Patrick Lavery
May 30th 2025
Article

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

Companies Reveal Their Next Moves in Manufacturing

Patrick Lavery
May 29th 2025
Article

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Digital Transformation in Pharmaceutical Manufacturing

Israel Ortíz
May 28th 2025
Article

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.


An antiviral used to treat hepatitis B and C | Image Credit © luchschenF

pharma& Secures MHRA Approval for Pegasys API Production at Loba Biotech

Christopher Cole
May 28th 2025
Article

MHRA approves Loba Biotech to manufacture Pegasys API, enabling pharma& to strengthen UK supply and ensure continued access for eligible patients.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

Download on Apple
© 2025 MJH Life Sciences

All rights reserved.