Product profile · United States
NUVESSA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Official FDA evidence establishes Final ANDA approval for this exact reference product, dosage form and strength. Exact 1.3% vaginal gel Final ANDA 216795 confirmed by the FDA first-generic table and current product record; the stale or inconsistently named linked letter is not used as the approval date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8877792 | 2028-02-02 | DP — | N | N | SOLVENT_FORMULATION | — | — | — |
| 8877792 | 2028-02-02 | DP — | N | N | SOLVENT_FORMULATION Independent claims restrict the aqueous composition to water/drug concentrations and combinations of polyol, polyol ether or low-carbon alcohol solvents. | — | — | — |
| 7893097 | 2028-02-19 | DP — | N | N | SOLVENT_FORMULATION | — | — | — |
| 7893097 | 2028-02-19 | DP — | N | N | SOLVENT_FORMULATION Independent claims restrict the aqueous composition to water/drug concentrations and combinations of polyol, polyol ether or low-carbon alcohol solvents. | — | — | — |
| 8658678 | 2028-06-27 | U U-1682 | N | N | FORMULATION_RESTRICTED_USE | — | — | — |
| 8658678 | 2028-06-27 | U U-1682 | N | N | FORMULATION_RESTRICTED_USE Claim 1 requires topical/mucosal treatment with a metronidazole concentration range and specified solvent classes. | — | — | — |
| 10238634 | 2032-06-28 | DP — | N | N | VAGINAL_GEL_FORMULATION | — | — | — |
| 10238634 | 2032-06-28 | DP — | N | N | VAGINAL_GEL_FORMULATION Independent claims restrict gel drug concentration, mucoadhesive polymers, water, a ternary solvent system and viscosity/pH or single-dose treatment conditions. | — | — | — |
| 10596155 | 2032-06-28 | DP — | N | N | GEL_TREATMENT_RESPONSE | — | — | — |
| 10596155 | 2032-06-28 | DP — | N | N | GEL_TREATMENT_RESPONSE Claim 1 requires a single-day metronidazole gel dose with specified solvents and a post-treatment Nugent-score outcome. | — | — | — |
| 8946276 | 2032-06-28 | U U-1664 | N | N | GEL_PERFORMANCE_RESTRICTED_USE | — | — | — |
| 8946276 | 2032-06-28 | U U-1664 | N | N | GEL_PERFORMANCE_RESTRICTED_USE Independent claims restrict bacterial vaginosis treatment to specified aqueous gel composition, performance or treatment-response conditions. | — | — | — |
| 9198858 | 2032-06-28 | U U-1664 | N | N | SINGLE_DOSE_GEL_USE | — | — | — |
| 9198858 | 2032-06-28 | U U-1664 | N | N | SINGLE_DOSE_GEL_USE Claim 1 restricts bacterial vaginosis treatment to a single intravaginal 65 mg metronidazole gel at about 1.3%, excluding specified ingredients. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 216795 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-18 | — | ENCUBE ETHICALS PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216795 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-18 | — | ENCUBE ETHICALS PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216795 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-03-18 | — | ENCUBE ETHICALS PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 216795 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-03-18 | — | ENCUBE ETHICALS PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 4 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 |
|---|---|---|---|---|---|---|
| 216795 / 001 | ENCUBE ETHICALS PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 216795 / 001 | ENCUBE ETHICALS PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 216795 / 001 | ENCUBE ETHICALS PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVAL | 2024-03-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 216795 / 001 | ENCUBE ETHICALS PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVAL | 2024-03-18 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2024-03-18 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA216795/001 -> NDA205223/001 | Source |
| PATENT | 2028-02-02 | FTO_TAIL | Independent claims restrict the aqueous composition to water/drug concentrations and combinations of polyol, polyol ether or low-carbon alcohol solvents. | Source |
| PATENT | 2028-02-19 | FTO_TAIL | Independent claims restrict the aqueous composition to water/drug concentrations and combinations of polyol, polyol ether or low-carbon alcohol solvents. | Source |
| PATENT | 2028-06-27 | FTO_TAIL | Claim 1 requires topical/mucosal treatment with a metronidazole concentration range and specified solvent classes. | Source |
| PATENT | 2032-06-28 | FTO_TAIL | Claim 1 restricts bacterial vaginosis treatment to a single intravaginal 65 mg metronidazole gel at about 1.3%, excluding specified ingredients. | Source |
| PATENT | 2032-06-28 | FTO_TAIL | Independent claims restrict bacterial vaginosis treatment to specified aqueous gel composition, performance or treatment-response conditions. | Source |
| PATENT | 2032-06-28 | FTO_TAIL | Claim 1 requires a single-day metronidazole gel dose with specified solvents and a post-treatment Nugent-score outcome. | Source |
| PATENT | 2032-06-28 | FTO_TAIL | Independent claims restrict gel drug concentration, mucoadhesive polymers, water, a ternary solvent system and viscosity/pH or single-dose treatment conditions. | Source |
| REGULATORY_STATUS | 2024-03-18 | DECISION_BASIS | Official FDA evidence establishes Final ANDA approval for this exact reference product, dosage form and strength. Exact 1.3% vaginal gel Final ANDA 216795 confirmed by the FDA first-generic table and current product record; the stale or inconsistently named linked letter is not used as the approval date. | 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.