Product profile · United States
VIMOVO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISCONTINUED_MARKETING_STATUS. Actual discontinuation date/year not established; do not substitute approval or review date. Store underlying canonical rights separately.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6875872 | 2014-05-27 | DS — | Y | N | TRUE_DS Optically pure esomeprazole magnesium compound; independent claims are not limited to a hydrate or specific diffraction pattern. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6875872 | 2014-11-27 | PED — | Y | N | TRUE_DS Optically pure esomeprazole magnesium compound; independent claims are not limited to a hydrate or specific diffraction pattern. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2014-11-27 | — |
| US5714504 | 2015-02-03 | DP/U U-1053 | N | N | DP_U Optically pure omeprazole-isomer pharmaceutical compositions and gastric-acid inhibition; not a standalone compound claim. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US5714504 | 2015-08-03 | PED — | N | N | DP_U Optically pure omeprazole-isomer pharmaceutical compositions and gastric-acid inhibition; not a standalone compound claim. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2015-08-03 | — |
| US5900424 | 2016-05-04 | DS/U U-1053 | N | N | SOLID_STATE Magnesium omeprazole with a crystallinity limitation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US5900424 | 2016-11-04 | PED — | N | N | SOLID_STATE Magnesium omeprazole with a crystallinity limitation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2016-11-04 | — |
| US6369085 | 2018-05-25 | DS/DP/U U-1053 | N | N | SOLID_STATE Esomeprazole magnesium trihydrate identified by diffraction peaks. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US7411070 | 2018-05-25 | DS/U U-1053 | N | N | SOLID_STATE Esomeprazole magnesium trihydrate and associated preparation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US7745466 | 2018-10-13 | DP/U U-1053 | N | N | DP Esomeprazole magnesium trihydrate/NSAID composition; compound-form restriction is retained. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6369085 | 2018-11-25 | PED — | N | N | SOLID_STATE Esomeprazole magnesium trihydrate identified by diffraction peaks. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2018-11-25 | — |
| US7411070 | 2018-11-25 | PED — | N | N | SOLID_STATE Esomeprazole magnesium trihydrate and associated preparation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | 2018-11-25 | — |
| US8557285 | 2022-05-31 | DP — | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US8852636 | 2022-05-31 | DP/U U-1052 | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US8858996 | 2022-05-31 | DP/U U-1052 | N | N | DP_U Coordinated naproxen/esomeprazole composition and pain/inflammation method. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9161920 | 2022-05-31 | U U-1760 | N | N | DP_U NSAID-ulcer-risk treatment with specified naproxen/esomeprazole delivery; full product scope requires satisfaction of all method limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9198888 | 2022-05-31 | U U-1781 | N | N | DP_U OA, RA and ankylosing-spondylitis treatment with ulcer-risk and coordinated-delivery limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9345695 | 2022-05-31 | DP — | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9707181 | 2022-05-31 | DP — | N | N | DP Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US6926907 | 2023-02-28 | DP/U U-1052 | N | N | DP_U Coordinated acid-inhibitor/NSAID release composition and pain/inflammation methods (claims 22 and 24). Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9393208 | 2029-09-03 | U U-1781 | N | N | DP_U 500-mg naproxen dosing and pharmacokinetic limitations; not full coverage of the 375-mg product. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US9220698 | 2031-03-10 | U U-1781 | N | N | DP_U Morning/evening 500-mg naproxen regimen with timing and pharmacokinetic limitations; not full coverage of the 375-mg product. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
| US8945621 | 2031-10-17 | U U-1661 | N | N | DP_U NSAID-ulcer prevention for concomitant low-dose aspirin users with specified naproxen dose; subgroup/strength limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NC | 2010-04-30 | 2013-04-30 | Original new dosage form, new combination or exact new product approval; covers its approved formulation/use scope at this original approval. | Y | Y | 2013-04-30 | Source | |
| NPP | 2017-07-06 | 2020-07-06 | VIMOVO adolescent JIA population, age 12 years or older and at least 38 kg; existing adult OA/RA/AS uses remain outside this scope. | N | N | — | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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 (25)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-05-27 | LISTING_CONTEXT | Optically pure esomeprazole magnesium compound; independent claims are not limited to a hydrate or specific diffraction pattern. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2014-11-27 | CANONICAL_ANCHOR | Optically pure esomeprazole magnesium compound; independent claims are not limited to a hydrate or specific diffraction pattern. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2015-02-03 | FTO_TAIL | Optically pure omeprazole-isomer pharmaceutical compositions and gastric-acid inhibition; not a standalone compound claim. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2015-08-03 | FTO_TAIL | Optically pure omeprazole-isomer pharmaceutical compositions and gastric-acid inhibition; not a standalone compound claim. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2016-05-04 | FTO_TAIL | Magnesium omeprazole with a crystallinity limitation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2016-11-04 | FTO_TAIL | Magnesium omeprazole with a crystallinity limitation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2018-05-25 | FTO_TAIL | Esomeprazole magnesium trihydrate identified by diffraction peaks. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2018-05-25 | FTO_TAIL | Esomeprazole magnesium trihydrate and associated preparation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2018-10-13 | FTO_TAIL | Esomeprazole magnesium trihydrate/NSAID composition; compound-form restriction is retained. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2018-11-25 | FTO_TAIL | Esomeprazole magnesium trihydrate and associated preparation. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2018-11-25 | FTO_TAIL | Esomeprazole magnesium trihydrate identified by diffraction peaks. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | OA, RA and ankylosing-spondylitis treatment with ulcer-risk and coordinated-delivery limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | Product formulation, delivery, excipient, release or preparation claims; no broad independent active-compound claim established. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | NSAID-ulcer-risk treatment with specified naproxen/esomeprazole delivery; full product scope requires satisfaction of all method limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2022-05-31 | FTO_TAIL | Coordinated naproxen/esomeprazole composition and pain/inflammation method. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2023-02-28 | FTO_TAIL | Coordinated acid-inhibitor/NSAID release composition and pain/inflammation methods (claims 22 and 24). Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2029-09-03 | FTO_TAIL | 500-mg naproxen dosing and pharmacokinetic limitations; not full coverage of the 375-mg product. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2031-03-10 | FTO_TAIL | Morning/evening 500-mg naproxen regimen with timing and pharmacokinetic limitations; not full coverage of the 375-mg product. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| PATENT | 2031-10-17 | FTO_TAIL | NSAID-ulcer prevention for concomitant low-dose aspirin users with specified naproxen dose; subgroup/strength limitations. Full product scope is not established by the retrieved claims and product evidence; no DS-equivalent promotion is made. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | VIMOVO adolescent JIA population, age 12 years or older and at least 38 kg; existing adult OA/RA/AS uses remain outside this scope. | Source |
| REGULATORY_EXCLUSIVITY | 2013-04-30 | SCOPE_CONTEXT | Original new dosage form, new combination or exact new product approval; covers its approved formulation/use scope at this original approval. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISCONTINUED_MARKETING_STATUS. Actual discontinuation date/year not established; do not substitute approval or review date. Store underlying canonical rights separately. | 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.