NEVANAC
· Patent Litigation & Settlement History ↓
Approved indications
Treatment of pain and inflammation associated with cataract surgery.
Product sourceCurrent GenericRadar decision
2014 DEEP_REVIEW: US5475034 use claims 1 and 3-5 cover nepafenac ophthalmic inflammation and pain across the approved cataract-surgery indication; DS-equivalent, not TRUE_DS. Patent anchor 2014-06-06 exceeds full-product NCE end 2010-08-19. Specific formulation DP/U tails extend to 2027-01-31. No actual launch date asserted. Current FDA Orange Book ANDA rows not detected; exhaustive historical Final ANDA absence not established.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 5475034 | 2014-06-06 | U U-100 | N | Y | DS_EQUIVALENT Operational GNR classification; no court non-infringement finding. Whole patent-history completeness not asserted. | — | — | — |
| 8071648 | 2025-12-02 | DP — | N | N | DP Operational GNR classification; no court non-infringement finding. Whole patent-history completeness not asserted. | — | — | — |
| 8324281 | 2025-12-02 | DP — | N | N | DP Operational GNR classification; no court non-infringement finding. Whole patent-history completeness not asserted. | — | — | — |
| 7834059 | 2027-01-31 | U U-1095 | N | N | U Operational GNR classification; no court non-infringement finding. Whole patent-history completeness not asserted. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2005-08-19 | 2010-08-19 | Five-year NCE for original NEVANAC approval; whole exact product and original indication. | Y | Y | 2010-08-19 | — | Source |
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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| EXCLUSIVITY | 2010-08-19 | EXCLUSIVITY_ANCHOR | NCE full-product end earlier than patent anchor. | Source |
| GENERIC | — | GENERIC_CHECK | FDA OB products.txt nepafenac: two NDA rows, zero ANDA rows in current file. Does not establish exhaustive historical absence of Final ANDA. | Source |
| PATENT | 2014-06-06 | PATENT_ANCHOR | Broad topical ophthalmic inflammation and pain treatment using explicitly listed nepafenac; no narrow excipient formulation limitation. Covers the approved indication. | Source |
| PATENT | 2025-12-02 | PATENT_TAIL | Closed composition with specified excipient concentrations and pH; no DS-equivalent promotion. | Source |
| PATENT | 2025-12-02 | PATENT_TAIL | Closed composition with fixed nepafenac/carbomer and ranges for other excipients; no DS-equivalent promotion. | Source |
| PATENT | 2027-01-31 | PATENT_TAIL | Treatment method limited to a specified closed formulation. FDA PSG permits supported excipient differences; not adopted as a mandatory whole-product DS-equivalent anchor. | Source |
| REGULATORY | 2005-08-19 | PRODUCT_IDENTITY | FDA approved exact product; pre-2006 user-authorized exception. | Source |
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.