Product profile · United States
REVATIO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
The exact product is currently listed as discontinued. No actual discontinuation event date was established; do not substitute approval date or snapshot date. Formal approval withdrawal was not established in the reviewed sources. The observation date confirms status, not the date of the event.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-287 | 2023-01-31 | 2026-01-31 | Labeling regarding a new adult PAH dosing regimen and PAH treatment in pediatric patients aged 1-17 years. | N | N | — | Source | |
| M-287 | 2023-01-31 | 2026-01-31 | Labeling regarding a new adult PAH dosing regimen and PAH treatment in pediatric patients aged 1-17 years. | N | N | — | Source |
2026-10-11 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 212260 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-31 | — | NOVITIUM PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211092 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | — | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212440 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | — | ALKEM LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212883 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | — | AJANTA PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211534 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-29 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213041 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-06 | — | INVAGEN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213814 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-29 | — | CHARTWELL RX SCIENCES LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213014 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-05-11 | — | HETERO LABS LTD UNIT V | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215522 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-16 | — | TARO PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212312 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-17 | — | TRIS PHARMA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214641 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-08 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211638 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-03-23 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215708 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-29 | — | ZYDUS LIFESCIENCES GLOBAL FZE | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214773 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-23 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214556 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-01 | — | GRANULES PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 15 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 |
|---|---|---|---|---|---|---|
| 212260 / 001 | NOVITIUM PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211092 / 001 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212440 / 001 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212883 / 001 | AJANTA PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211534 / 001 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213041 / 001 | INVAGEN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213814 / 001 | CHARTWELL RX SCIENCES LLC | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213014 / 001 | HETERO LABS LTD UNIT V | FINAL_APPROVAL · FINAL_APPROVED | 2021-05-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215522 / 001 | TARO PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212312 / 001 | TRIS PHARMA INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214641 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211638 / 001 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-03-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215708 / 001 | ZYDUS LIFESCIENCES GLOBAL FZE | FINAL_APPROVAL · FINAL_APPROVED | 2022-09-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214773 / 001 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-12-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214556 / 001 | GRANULES PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Labeling regarding a new adult PAH dosing regimen and PAH treatment in pediatric patients aged 1-17 years. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | The exact product is currently listed as discontinued. No actual discontinuation event date was established; do not substitute approval date or snapshot date. Formal approval withdrawal was not established in the reviewed sources. The observation date confirms status, not the date of the event. | 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.