The Medicines Patent Pool (MPP) has signed agreements with ten patent holders for 13 HIV antiretrovirals, one HIV technology platform, a tuberculosis treatment and three hepatitis C direct-acting antivirals. 23 generic manufacturers and product developers have now signed MPP sublicensing agreements.
Overview of all licensing and sublicensing agreements
Generic competition is making a difference in fostering lower prices and improving treatment coverage. Generic partners have distributed 49.71 million patient-years of HIV and hepatitis C products, saving international procurers USD 1.96 billion (January 2012-December 2020).
Slide decks highlighting progress of MPP’s generic partners in developing, manufacturing and supplying MPP-licensed medicines, are available for:
- all MPP’s sublicensees – updated twice a year, linked to the KPMG report on MPP’s impact (Last update: April 2021 – data as of December 2020)
- dolutegravir (DTG)-based regimens
- daclatasvir (DAC)-based regimens
(Last update: April 2021 – data as of December 2020)
The information presented on the interactive map below, under the “Patent and licensing status” filter, is sourced from MPP’s patent and licensing database, MedsPaL. Users should NOT consider MedsPaL a complete and authoritative source of patent information, and it is not meant to provide a ‘freedom-to-operate’ analysis. It only provides a snapshot at a point in time, based on the information available to us.
We do not accept any legal responsibility for the accuracy of data. In particular, we do not guarantee it is complete, up to date or fit for specific purposes. Users should undertake additional country search and legal analysis before making any procurement or business decision.
Key
HIV Hepatitis C Tuberculosis| Products | Products | Companies developing the product | Pending Approval | Ready to Supply | Countries where | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| WHO-PQ* | USFDA** | WHO-PQ* Approved | USFDA** Approved | ERP*** Approved | Product is Filed | Product is Approved | Product is Supplied | |||
12 | 3 | 8         | 6  | 18
| 44
| 109
| ||||
2 | 1 | 1 | 1 | |||||||
15 | 4 | 4 | 8   | 7  | 18
| 47
| 90
| |||
9 | 4 | 2 | 23
| 10
| 6
| |||||
4 | 1 | 5
| ||||||||
5 | 4 | 17
| 10
| 1
| ||||||
5 | 1 | 10
| ||||||||
8 | 4 | |||||||||
5 | 2 | 2 | 3 | 25
| 30
| 87
| ||||
3 | 1 | 2 | 16
| 43
| 111
| |||||
1 | 1 | 2
| 11
| 46
| ||||||
1 | 1 | |||||||||
DAC  | 5 | 4 | 18
| 34
| 34
| |||||
DAC+SOF | 2 | 2 | 9
| 10
| 9
| |||||
*[WHO-PQ] Prequalification from the World Health Organization (WHO) | **[USFDA] U.S. Food and Drug Administration | ***[ERP] Expert Review Panel hosted by the Quality and Safety of Medicines department of the WHO and making recommendations to the Global Fund. Temporary approval through the ERP, valid for one year, is permitted where WHO-PQ or USFDA approval are not yet available. This does not apply to products under licences with Gilead Sciences (those licences do not accept ERP).
Interactive map:
– Patent and licensing status: last updated on 30 November 2020 (see announcement);
– Product availability data from MPP sublicensees: last updated in March 2021 (data as of 31 December 2020).
Last update of the interactive table in March 2021 (data as of 31 December 2020)
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions