• Home
  • About Us
    • About Us
    • Subscribe
    • Privacy Policy
  • Advertise
    • Advertise On IP Watch
    • Editorial Calendar
  • Videos
  • Links
  • Help

Intellectual Property Watch

Original news and analysis on international IP policy

  • Copyright
  • Patents
  • Trademarks
  • Opinions
  • People News
  • Venues
    • Bilateral/Regional Negotiations
    • ITU/ICANN
    • United Nations – other
    • WHO
    • WIPO
    • WTO/TRIPS
    • Africa
    • Asia/Pacific
    • Europe
    • Latin America/Caribbean
    • North America
  • Themes
    • Access to Knowledge/ Open Innovation & Science
    • Food Security/ Agriculture/ Genetic Resources
    • Finance
    • Health & IP
    • Human Rights
    • Internet Governance/ Digital Economy/ Cyberspace
    • Lobbying
    • Technical Cooperation/ Technology Transfer
  • Health Policy Watch

Two Generics Companies Apply For First WHO Prequalification Of Novel Antiretroviral

10/11/2016 by Intellectual Property Watch Leave a Comment

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

Today, the Medicines Patent Pool announced that two generic drug companies applied for the World Health Organization prequalification of an innovative antiretroviral.

Cipla and Mylan, both MPP manufacturing partners, are the first companies to apply for prequalification of generic dolutegravir, an antiretroviral that the MPP licences from ViiV Healthcare in 2014, according to an MPP press release.

WHO prequalification of Cipla and Mylan is necessary to allow international procurers such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF and UNITAID to purchase and distribute the treatment in developing countries, the MPP said.

According to the MPP dolutegravir (DTG) is considered a significant improvement in antiretroviral therapy. ViiV Healthcare granted the MPP two non-exclusive licenses for the generic manufacture of DTG, the press release said, one for the production of the medicine for adults and another for children.

“Both licences permit generic pharmaceutical companies based anywhere in the world to manufacture DTG and to combine the treatment with other drugs to develop fixed-dose combinations of regimens recommended by the WHO,” it said.

Currently, nine MPP licensees are developing DTG as an active pharmaceutical ingredient and in formulations, said the MPP, and they will be submitting dossiers to the WHO prequalification programme and/or the US Food and Drug Administration, some of them very soon.

“Robust competition among MPP licensees will improve access for this key medicine,” said Greg Perry, MPP’s executive director.

 

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

Related

Creative Commons License"Two Generics Companies Apply For First WHO Prequalification Of Novel Antiretroviral" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Filed Under: IP-Watch Briefs, IP Policies, Language, Themes, Venues, English, Health & IP, Patents/Designs/Trade Secrets, WHO

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

  • Email
  • Facebook
  • LinkedIn
  • RSS
  • Twitter
  • Vimeo
My Tweets

IPW News Briefs

Saudis Seek Alternative Energy Partners Through WIPO Green Program

Chinese IP Officials Complete Study Of UK, European IP Law

Perspectives on the US

In US, No Remedies For Growing IP Infringements

US IP Law – Big Developments On The Horizon In 2019

More perspectives on the US...

Supported Series: Civil Society And TRIPS Flexibilities

Civil Society And TRIPS Flexibilities Series – Translations Now Available

The Myth Of IP Incentives For All Nations – Q&A With Carlos Correa

Read the TRIPS flexibilities series...

Paid Content

Interview With Peter Vanderheyden, CEO Of Article One Partners

More paid content...

IP Delegates in Geneva

  • IP Delegates in Geneva
  • Guide to Geneva-based Public Health and IP Organisations

All Story Categories

Other Languages

  • Français
  • Español
  • 中文
  • اللغة العربية

Archives

  • Archives
  • Monthly Reporter

Staff Access

  • Writers

Sign up for free news alerts

This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy

Copyright © 2021 · Global Policy Reporting

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.