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
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Related Content

ADELAIDE, SOUTH AUSTRALIA. - On November 15, 2018. – The University of South Australia is a public university, it is main campus is located on North Terrace in the Adelaide city centre | Image Credit: © arliftatoz2205 - stock.adobe.com

Why You Should Know About a New Weekly Injectable for Parkinson’s

Christopher Cole
July 15th 2025
Article

Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.


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.


Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

FDA Publishes More Than 200 Complete Response Letters

Christopher Cole
July 11th 2025
Article

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.


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.


Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.


Pharmaceutical research and development in laboratory, with focus on medicine preparation, powder substances, and glass vials for drug formulation and testing | Image Credit: © felix_brönnimann - stock.adobe.com

Dosage Form Compounding in the Workplace Environment

Paul L. Pluta;Alan M. Mancini;Nishant B. Thakar;Varanya Chaiyaperm
July 8th 2025
Article

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

Related Content

ADELAIDE, SOUTH AUSTRALIA. - On November 15, 2018. – The University of South Australia is a public university, it is main campus is located on North Terrace in the Adelaide city centre | Image Credit: © arliftatoz2205 - stock.adobe.com

Why You Should Know About a New Weekly Injectable for Parkinson’s

Christopher Cole
July 15th 2025
Article

Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.


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.


Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

FDA Publishes More Than 200 Complete Response Letters

Christopher Cole
July 11th 2025
Article

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.


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.


Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.


Pharmaceutical research and development in laboratory, with focus on medicine preparation, powder substances, and glass vials for drug formulation and testing | Image Credit: © felix_brönnimann - stock.adobe.com

Dosage Form Compounding in the Workplace Environment

Paul L. Pluta;Alan M. Mancini;Nishant B. Thakar;Varanya Chaiyaperm
July 8th 2025
Article

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

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

© 2025 MJH Life Sciences

All rights reserved.