Product profile · United States
MAVYRET
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US10286029 c1/29 HCV8-12/16weeks, no fixed age/dose;PED. Tablet formulation tail2036-12-24.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10028937 | 2030-06-10 | U U-4206 | — | — | — | — | — | — |
| 10028937 | 2030-06-10 | U U-2141 | — | — | — | — | — | — |
| 10028937 | 2030-06-10 | U U-3237 | — | — | — | — | — | — |
| 10039754 | 2030-06-10 | U U-4206 | — | — | — | — | — | — |
| 10039754 | 2030-06-10 | U U-3237 | — | — | — | — | — | — |
| 10039754 | 2030-06-10 | U U-2141 | — | — | — | — | — | — |
| 9586978 | 2030-11-06 | U U-2141 | — | — | — | — | — | — |
| 9586978 | 2030-11-06 | U U-4206 | — | — | — | — | — | — |
| 9586978 | 2030-11-06 | U U-3237 | — | — | — | — | — | — |
| 10028937 | 2030-12-10 | — — | — | — | — | — | 2030-12-10 | — |
| 10028937 | 2030-12-10 | ORANGE_BOOK U-2141,U-3237,U-4206 | N | Y | DS_EQUIVALENT HCV treatment with pibrentasvir compound + HCV protease inhibitor; includes the marketed combination without genotype, age, or solid-form restrictions. | — | 2030-12-10 | — |
| 10039754 | 2030-12-10 | — — | — | — | — | — | 2030-12-10 | — |
| 10039754 | 2030-12-10 | ORANGE_BOOK U-2141,U-3237,U-4206 | N | Y | DS_EQUIVALENT HCV treatment using glecaprevir compound and another anti-HCV agent, no label-population restriction. | — | 2030-12-10 | — |
| 9586978 | 2031-05-06 | — — | — | — | — | — | 2031-05-06 | — |
| 9586978 | 2031-05-06 | ORANGE_BOOK U-2141,U-3237,U-4206 | N | Y | DS_EQUIVALENT HCV treatment using pibrentasvir compound genus, without genotype/age/form restriction. | — | 2031-05-06 | — |
| 8648037 | 2032-01-19 | DS/DP/U U-2141 | — | — | — | — | — | — |
| 8648037 | 2032-01-19 | DS/DP/U U-4206 | — | — | — | — | — | — |
| 8648037 | 2032-01-19 | DS/DP/U U-3237 | — | — | — | — | — | — |
| 8937150 | 2032-05-18 | DS/DP — | — | — | — | — | — | — |
| 8648037 | 2032-07-19 | — — | — | — | — | — | 2032-07-19 | — |
| 8648037 | 2032-07-19 | ORANGE_BOOK U-2141,U-3237,U-4206 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2032-07-19 | — |
| 8937150 | 2032-11-18 | — — | — | — | — | — | 2032-11-18 | — |
| 8937150 | 2032-11-18 | ORANGE_BOOK — | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2032-11-18 | — |
| 10286029 | 2034-03-14 | U U-3237 | — | — | — | — | — | — |
| 10286029 | 2034-03-14 | U U-4206 | — | — | — | — | — | — |
| 11484534 | 2034-03-14 | U U-3237 | — | — | — | — | — | — |
| 11484534 | 2034-03-14 | U U-4206 | — | — | — | — | — | — |
| 10286029 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 10286029 | 2034-09-14 | ORANGE_BOOK U-3237,U-4206 | N | Y | DS_EQUIVALENT Independent claims 1 and 29 together cover interferon/ribavirin-free glecaprevir + pibrentasvir for 8-12 or 16 weeks; current label regimens use these durations. | — | 2034-09-14 | — |
| 11484534 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 11484534 | 2034-09-14 | ORANGE_BOOK U-3237,U-4206 | N | Y | DS_EQUIVALENT English description not available. | — | 2034-09-14 | — |
| RE48923 | 2035-05-08 | DS — | — | — | — | — | — | — |
| 9321807 | 2035-06-05 | DS — | — | — | — | — | — | — |
| RE48923 | 2035-11-08 | — — | — | — | — | — | 2035-11-08 | — |
| RE48923 | 2035-11-08 | ORANGE_BOOK — | N | N | PROCESS Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor. | — | 2035-11-08 | — |
| 9321807 | 2035-12-05 | — — | — | — | — | — | 2035-12-05 | — |
| 9321807 | 2035-12-05 | ORANGE_BOOK — | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2035-12-05 | — |
| 11246866 | 2036-06-24 | DP — | — | — | — | — | — | — |
| 11246866 | 2036-12-24 | — — | — | — | — | — | 2036-12-24 | — |
| 11246866 | 2036-12-24 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2036-12-24 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-230 | 2018-08-06 | 2021-08-06 | REVISIONS TO THE GLECAPREVIR/PIBRENTASVIR COMBINATION PRODUCT PRESCRIBING INFORMATION TO INCLUDE SAFETY AND EFFICACY DATA FROM THE HCV/HIV-1 COINFECTION STUDY M14-730 AND FROM THE LIVER AND RENAL TRANSPLANT STUDY M13-596 | N | N | — | Source | |
| NPP | 2019-04-30 | 2022-04-30 | English description not available. | N | N | — | Source | |
| NCE | 2017-08-03 | 2022-08-03 | English description not available. | Y | Y | — | Source | |
| D-175 | 2019-09-26 | 2022-09-26 | EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY | N | N | — | Source | |
| PED | 2022-04-30 | 2022-10-30 | English description not available. | N | N | — | Source | |
| PED | 2022-08-03 | 2023-02-03 | English description not available. | Y | Y | — | Source | |
| PED | 2022-09-26 | 2023-03-26 | English description not available. | N | N | — | Source | |
| M-259 | 2020-04-10 | 2023-04-10 | INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION | N | N | — | Source | |
| PED | 2023-04-10 | 2023-10-10 | English description not available. | N | N | — | Source | |
| ODE-232 | — | 2026-04-30 | — | — | — | — | Source | |
| ODE-232 | 2019-04-30 | 2026-04-30 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A) | N | N | — | Source | |
| ODE-233 | — | 2026-04-30 | — | — | — | — | Source | |
| ODE-233 | 2019-04-30 | 2026-04-30 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH | N | N | — | Source | |
| PED | — | 2026-10-30 | — | — | — | — | Source | |
| PED | 2026-04-30 | 2026-10-30 | English description not available. | N | N | — | Source | |
| I-967 | — | 2028-06-10 | — | — | — | — | Source | |
| I-967 | 2025-06-10 | 2028-06-10 | TREATMENT OF ACUTE HEPATITIS C VIRUS (HCV) INFECTION IN ADULTS AND PEDIATRIC PATIENTS AGES 3 TO LESS THAN 18 YEARS OF AGE | N | N | — | Source | |
| ODE-372 | — | 2028-06-10 | — | — | — | — | Source | |
| ODE-372 | 2021-06-10 | 2028-06-10 | FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH | N | N | — | Source | |
| PED | — | 2028-12-10 | — | — | — | — | Source | |
| PED | 2028-06-10 | 2028-12-10 | English description not available. | N | N | — | Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US10286029 c1/29 HCV8-12/16weeks, no fixed age/dose;PED. Tablet formulation tail2036-12-24. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-09-14 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-09-14 | 2026-10-13 22:23:16 |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.