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. 22 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 38.75 million patient-years of HIV and hepatitis C products, saving international procurers USD 1.66 billion (January 2012-June 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: October 2020 – data as of June 2020)
- dolutegravir (DTG)-based regimens
- daclatasvir (DAC)-based regimens
(Last update: October 2020 – data as of June 2020)
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 Sold | |||
12 | 3 | 2 | 6       | 5   | 21
| 44
| 101
| |||
15 | 5 | 5 | 7   | 6  | 21
| 45
| 81
| |||
9 | 5 | 1 | 23
| 9
| 5
| |||||
3 | 1 | 2
| ||||||||
4 | 3 | 18
| 9
| 1
| ||||||
4 | 1 | 10
| ||||||||
7 | 3 | |||||||||
5 | 2 | 2 | 3 | 16
| 34
| 80
| ||||
DRV/r  | 2 | 1 | 10
| |||||||
3 | 1 | 2 | 15
| 43
| 106
| |||||
1 | 1 | 2
| 11
| 33
| ||||||
1 | 1 | |||||||||
DAC  | 5 | 2 | 3 | 22
| 34
| 28
| ||||
DAC+SOF | 3 | 1 | 1 | 12
| 9
| 7
| ||||
*[WHO-PQ] Prequalification from the World Health Organization | **[USFDA] U.S. Food and Drug Administration | ***[ERP] Expert Review Panel led by the Global Fund. Temporary approval through an ERP 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 in 12 October 2020;
– Product availability data from MPP sublicensees: last updated in 30 September 2020 (data as of 30 June 2020).
Last update of the interactive table: 30 September 2020 (data as of 30 June 2020)
Note: Sales may occur in countries in the absence of registration via procurement channels, registration waivers and/or exemptions