GELNIQUE 3%
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2020 DEEP_REVIEW; POST_ANCHOR_TAIL.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US7029694 | 2020-04-26 | DP/U U-318 | N | Y | DS_EQUIVALENT Independent method claim 1 covers overactive-bladder therapy with topical oxybutynin gel and an oxybutynin/metabolite AUC ratio 0.5:1–5:1. The GELNIQUE 3% label reports approximately 1:1 and lists incontinence, urgency and frequency under the same OAB indication. | — | — | — |
| US7179483 | 2020-04-26 | U U-318 | N | Y | DS_EQUIVALENT Independent method claim 1 covers OAB treatment via transdermal oxybutynin, including gel, with the same AUC condition. GELNIQUE 3% label pharmacokinetics and its complete OAB indication correspond. | — | — | — |
| US8241662 | 2020-04-26 | U U-318 | N | N | U_DP OAB treatment by unoccluded gel with specified water, solvent, gelling-agent and AUC requirements. Indication matches GELNIQUE, but public label does not establish the claimed quantitative water/solvent composition for every approved use; retain as restricted method/formulation rather than promote from OAB wording alone. | — | — | — |
| US7198801 | 2022-06-25 | DP — | N | N | DP Transdermal/transmucosal vehicle comprising alkanol, polyalcohol and diethylene-glycol monoalkyl ether, excluding long-chain fatty constituents; no all-indication clinical method. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2011-12-07 | 2014-12-07 | NP matches exact GELNIQUE 3% gel and its single overactive-bladder indication, including incontinence, urgency and frequency. | Y | Y | 2014-12-07 | 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 (6)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2020-04-26 | LISTING_CONTEXT | OAB treatment by unoccluded gel with specified water, solvent, gelling-agent and AUC requirements. Indication matches GELNIQUE, but public label does not establish the claimed quantitative water/solvent composition for every approved use; retain as restricted method/formulation rather than promote from OAB wording alone. | Source |
| PATENT | 2020-04-26 | CANONICAL_ANCHOR | Independent method claim 1 covers overactive-bladder therapy with topical oxybutynin gel and an oxybutynin/metabolite AUC ratio 0.5:1–5:1. The GELNIQUE 3% label reports approximately 1:1 and lists incontinence, urgency and frequency under the same OAB indication. | Source |
| PATENT | 2020-04-26 | CANONICAL_ANCHOR | Independent method claim 1 covers OAB treatment via transdermal oxybutynin, including gel, with the same AUC condition. GELNIQUE 3% label pharmacokinetics and its complete OAB indication correspond. | Source |
| PATENT | 2022-06-25 | FTO_TAIL | Transdermal/transmucosal vehicle comprising alkanol, polyalcohol and diethylene-glycol monoalkyl ether, excluding long-chain fatty constituents; no all-indication clinical method. | Source |
| REGULATORY_EXCLUSIVITY | 2014-12-07 | SCOPE_CONTEXT | NP matches exact GELNIQUE 3% gel and its single overactive-bladder indication, including incontinence, urgency and frequency. | Source |
| REGULATORY_STATUS | 2017-07-21 | TERMINAL_STATUS | FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2020 DEEP_REVIEW; POST_ANCHOR_TAIL. | 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.