Product profile · United States
HARVONI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2033-03-14; DEEP_REVIEW; latest post-anchor right 2034-07-30; Final exact ANDA link not identified; not certified generic absence.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8334270 | 2028-03-21 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8580765 | 2028-03-21 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8735372 | 2028-03-21 | U U-1470 | — | — | — | — | — | — |
| 9085573 | 2028-03-21 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8334270 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8334270 | 2028-09-21 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 8580765 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8580765 | 2028-09-21 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 8735372 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 8735372 | 2028-09-21 | ORANGE_BOOK U-1470 | N | Y | DS_EQUIVALENT English description not available. | — | 2028-09-21 | — |
| 9085573 | 2028-09-21 | — — | — | — | — | — | 2028-09-21 | — |
| 9085573 | 2028-09-21 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2028-09-21 | — |
| 7964580 | 2029-03-26 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8633309 | 2029-03-26 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8889159 | 2029-03-26 | DP/U U-1470 | — | — | — | — | — | — |
| 7964580 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 7964580 | 2029-09-26 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2029-09-26 | — |
| 8633309 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 8633309 | 2029-09-26 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | — | 2029-09-26 | — |
| 8889159 | 2029-09-26 | — — | — | — | — | — | 2029-09-26 | — |
| 8889159 | 2029-09-26 | ORANGE_BOOK U-1470 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2029-09-26 | — |
| 8088368 | 2030-05-12 | DS/DP — | — | — | — | — | — | — |
| 8273341 | 2030-05-12 | U U-1470 | — | — | — | — | — | — |
| 8822430 | 2030-05-12 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8841278 | 2030-05-12 | DP/U U-1470 | — | — | — | — | — | — |
| 9511056 | 2030-05-12 | DP/U U-1470 | — | — | — | — | — | — |
| 9284342 | 2030-09-13 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 8088368 | 2030-11-12 | — — | — | — | — | — | 2030-11-12 | — |
| 8088368 | 2030-11-12 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | 2030-11-12 | — |
| 8273341 | 2030-11-12 | — — | — | — | — | — | 2030-11-12 | — |
| 8273341 | 2030-11-12 | ORANGE_BOOK U-1470 | N | Y | DS_EQUIVALENT English description not available. | — | 2030-11-12 | — |
| 8822430 | 2030-11-12 | — — | — | — | — | — | 2030-11-12 | — |
| 8822430 | 2030-11-12 | ORANGE_BOOK U-1470 | Y | N | TRUE_DS English description not available. | — | 2030-11-12 | — |
| 8841278 | 2030-11-12 | — — | — | — | — | — | 2030-11-12 | — |
| 8841278 | 2030-11-12 | ORANGE_BOOK U-1470 | N | Y | DS_EQUIVALENT English description not available. | — | 2030-11-12 | — |
| 9511056 | 2030-11-12 | — — | — | — | — | — | 2030-11-12 | — |
| 9511056 | 2030-11-12 | ORANGE_BOOK U-1470 | N | Y | DS_EQUIVALENT English description not available. | — | 2030-11-12 | — |
| 8618076 | 2030-12-11 | DS/DP/U U-1470 | — | — | — | — | — | — |
| 9284342 | 2031-03-13 | — — | — | — | — | — | 2031-03-13 | — |
| 9284342 | 2031-03-13 | ORANGE_BOOK U-1470 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-03-13 | — |
| 8618076 | 2031-06-11 | — — | — | — | — | — | 2031-06-11 | — |
| 8618076 | 2031-06-11 | ORANGE_BOOK U-1470 | N | N | DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | — | 2031-06-11 | — |
| 10456414 | 2032-09-14 | DP — | — | — | — | — | — | — |
| 10456414 | 2032-09-14 | ORANGE_BOOK — | N | Y | DS_EQUIVALENT English description not available. | — | — | — |
| 9393256 | 2032-09-14 | U U-1470 | — | — | — | — | — | — |
| 9393256 | 2033-03-14 | — — | — | — | — | — | 2033-03-14 | — |
| 9393256 | 2033-03-14 | ORANGE_BOOK U-1470 | N | Y | DS_EQUIVALENT English description not available. | — | 2033-03-14 | — |
| 10039779 | 2034-01-30 | DS/DP/U U-2369 | — | — | — | — | — | — |
| 10039779 | 2034-01-30 | DS/DP/U U-2370 | — | — | — | — | — | — |
| 10039779 | 2034-07-30 | — — | — | — | — | — | 2034-07-30 | — |
| 10039779 | 2034-07-30 | ORANGE_BOOK U-2369,U-2370 | N | N | DP English description not available. | — | 2034-07-30 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| D-153 | 2015-11-12 | 2018-11-12 | IN COMBINATION WITH RIBAVIRIN FOR 12 WEEKS, FOR THE TREATMENT OF GENOTYPE 1, CHRONIC HEPATITIS C TREATMENT EXPERIENCED PATIENTS WITH COMPENSATED CIRRHOSIS BASED UPON THE RESULTS OF THE SIRIUS STUDY | N | N | — | Source | |
| I-718 | 2015-11-12 | 2018-11-12 | EXPANDED INDICATION TO INCLUDE SUBJECTS INFECTED WITH CHRONIC HEPATITIS C, GENOTYPE 6 VIRUS INFECTION BASED UPON THE RESULTS OF THE ELECTRON- 2 STUDY | N | N | — | Source | |
| I-719 | 2015-11-12 | 2018-11-12 | EXPANDED INDICATION TO INCLUDE THE TREATMENT OF SUBJECTS WITH GENOTYPE 5 CHRONIC HEPATITIS C VIRUS INFECTION BASED ON THE RESULTS FROM STUDY GS-US-337-119 | N | N | — | Source | |
| I-720 | 2015-11-12 | 2018-11-12 | EXPANDED INDICATION TO INCLUDE TREATMENT OF GENOTYPE 4, CHRONIC HEPATITIS C VIRUS INFECTION BASED UPON THE RESULTS FROM STUDIES ION-4 AND GS-US-337-119 | N | N | — | Source | |
| NPP | 2015-11-12 | 2018-11-12 | English description not available. | N | N | — | Source | |
| D-158 | 2016-02-12 | 2019-02-12 | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 1 HCV INFECTION | N | N | — | Source | |
| D-159 | 2016-02-12 | 2019-02-12 | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 4 HCV INFECTION | N | N | — | Source | |
| D-160 | 2016-02-12 | 2019-02-12 | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE PATIENTS WITH DECOMPENSATED CIRRHOSIS WITH GENOTYPE 1 HCV INFECTION | N | N | — | Source | |
| NCE | 2014-10-10 | 2019-10-10 | English description not available. | Y | Y | — | Source | |
| NPP | 2017-04-07 | 2020-04-07 | English description not available. | N | N | — | Source | |
| D-177 | 2019-11-15 | 2022-11-15 | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS | N | N | — | Source | |
| ODE-136 | 2017-04-07 | 2024-04-07 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS | N | N | — | Source | |
| PED | 2024-04-07 | 2024-10-07 | English description not available. | N | N | — | Source | |
| ODE* | — | 2026-08-28 | — | — | — | — | Source | |
| ODE* | 2019-08-28 | 2026-08-28 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | 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 (32)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-09-21 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2028-09-21 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2028-09-21 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2028-09-21 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2029-09-26 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2029-09-26 | HISTORICAL_CONTEXT | Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate. | Source |
| PATENT | 2029-09-26 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2030-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2030-11-12 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2031-03-13 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2031-06-11 | HISTORICAL_CONTEXT | Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion. | Source |
| PATENT | 2032-09-14 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-03-14 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2034-07-30 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | IN COMBINATION WITH RIBAVIRIN FOR 12 WEEKS, FOR THE TREATMENT OF GENOTYPE 1, CHRONIC HEPATITIS C TREATMENT EXPERIENCED PATIENTS WITH COMPENSATED CIRRHOSIS BASED UPON THE RESULTS OF THE SIRIUS STUDY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 1 HCV INFECTION | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 4 HCV INFECTION | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE PATIENTS WITH DECOMPENSATED CIRRHOSIS WITH GENOTYPE 1 HCV INFECTION | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | EXPANDED INDICATION TO INCLUDE SUBJECTS INFECTED WITH CHRONIC HEPATITIS C, GENOTYPE 6 VIRUS INFECTION BASED UPON THE RESULTS OF THE ELECTRON- 2 STUDY | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | EXPANDED INDICATION TO INCLUDE THE TREATMENT OF SUBJECTS WITH GENOTYPE 5 CHRONIC HEPATITIS C VIRUS INFECTION BASED ON THE RESULTS FROM STUDY GS-US-337-119 | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | EXPANDED INDICATION TO INCLUDE TREATMENT OF GENOTYPE 4, CHRONIC HEPATITIS C VIRUS INFECTION BASED UPON THE RESULTS FROM STUDIES ION-4 AND GS-US-337-119 | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2033-03-14 | CANONICAL_DECISION | Canonical 2033-03-14; DEEP_REVIEW; latest post-anchor right 2034-07-30; Final exact ANDA link not identified; not certified generic absence. | Source |
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.