FDA Orange Book
Is there a generic for Mavyret?
Mavyret contains glecaprevir and pibrentasvir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mavyret (glecaprevir and pibrentasvir). The Orange Book shows its last listed patent expires December 24, 2036 and its last listed exclusivity ends December 10, 2028.
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Mavyret products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 50MG/PACKET;20MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG;40MG | Marketed (Rx) | None | 0 | None |
NDA 215110, 209394, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mavyret patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10039754 | June 10, 2030 | Method of use | U-4206 | 215110 |
| 10028937 | June 10, 2030 | Method of use | U-4206 | 215110 |
| 10028937 | June 10, 2030 | Method of use | U-3238 | 215110 |
| 10039754 | June 10, 2030 | Method of use | U-3238 | 215110 |
| 10039754 | June 10, 2030 | Method of use | U-2141 | 209394 |
| 10028937 | June 10, 2030 | Method of use | U-2141 | 209394 |
| 10028937 | June 10, 2030 | Method of use | U-3237 | 209394 |
| 10039754 | June 10, 2030 | Method of use | U-3237 | 209394 |
| 9586978 | November 6, 2030 | Method of use | U-4206 | 215110 |
| 9586978 | November 6, 2030 | Method of use | U-3238 | 215110 |
| 9586978 | November 6, 2030 | Method of use | U-3237 | 209394 |
| 9586978 | November 6, 2030 | Method of use | U-2141 | 209394 |
| 10028937*PED | December 10, 2030 | Method of use | None | 215110 |
| 10039754*PED | December 10, 2030 | Method of use | None | 215110 |
| 9586978*PED | May 6, 2031 | Method of use | None | 215110 |
| 8648037 | January 19, 2032 | Drug substance, Drug product | U-4206 | 215110 |
| 8648037 | January 19, 2032 | Drug substance, Drug product | U-3238 | 215110 |
| 8648037 | January 19, 2032 | Drug substance, Drug product | U-2141 | 209394 |
| 8648037 | January 19, 2032 | Drug substance, Drug product | U-3237 | 209394 |
| 8937150 | May 18, 2032 | Drug substance, Drug product | None | 215110 |
| 8648037*PED | July 19, 2032 | Method of use | None | 215110 |
| 8937150*PED | November 18, 2032 | Method of use | None | 215110 |
| 10286029 | March 14, 2034 | Method of use | U-4206 | 215110 |
| 10286029 | March 14, 2034 | Method of use | U-3238 | 215110 |
| 11484534 | March 14, 2034 | Method of use | U-4206 | 209394 |
| 11484534 | March 14, 2034 | Method of use | U-3237 | 209394 |
| 10286029 | March 14, 2034 | Method of use | U-3237 | 209394 |
| 10286029*PED | September 14, 2034 | Method of use | None | 215110 |
| 11484534*PED | September 14, 2034 | Method of use | None | 209394 |
| RE48923 | May 8, 2035 | Drug substance | None | 215110 |
| 9321807 | June 5, 2035 | Drug substance, Drug product | None | 215110 |
| RE48923*PED | November 8, 2035 | Method of use | None | 215110 |
| 9321807*PED | December 5, 2035 | Method of use | None | 215110 |
| 11246866 | June 24, 2036 | Drug product | None | 209394 |
| 11246866*PED | December 24, 2036 | Method of use | None | 209394 |
Mavyret exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-232 | Orphan drug exclusivity | April 30, 2026 | 209394 |
| ODE-233 | Orphan drug exclusivity | April 30, 2026 | 209394 |
| PED | Pediatric exclusivity | October 30, 2026 | 209394 |
| I-967 | New indication | June 10, 2028 | 215110 |
| ODE-372 | Orphan drug exclusivity | June 10, 2028 | 215110 |
| PED | Pediatric exclusivity | December 10, 2028 | 215110 |
Mavyret NDC codes
Questions
Is there a generic for Mavyret?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mavyret (glecaprevir and pibrentasvir). The Orange Book shows its last listed patent expires December 24, 2036 and its last listed exclusivity ends December 10, 2028.
What is the generic name for Mavyret?
The active ingredient in Mavyret is glecaprevir and pibrentasvir, per the FDA Orange Book.
When does the Mavyret patent expire?
The last patent listed for Mavyret in the Orange Book expires December 24, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.