RESTASIS MULTIDOSE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. RESTASIS single-use product 001 and RESTASIS MULTIDOSE product 002 share an NDA and concentration but have distinct presentation and TE records. The available AB-rated ANDAs and the Mylan 205894 approval identify RESTASIS, not a verified multidose product-002 reference. Do not transfer EG from single-use to multidose.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8292129 | 2031-02-25 | DP — | N | N | LIQUID_DISPENSER_CAP | — | — | — |
| 8292129 | 2031-02-25 | DP — | N | N | LIQUID_DISPENSER_CAP Independent claims require a dispenser housing/reservoir/outlet/air inlet and a removable cap providing specified gas-tight closures. | — | — | — |
| 8561859 | 2032-04-16 | DP — | N | N | LIQUID_DISPENSER_FLOW_BRAKE | — | — | — |
| 8561859 | 2032-04-16 | DP — | N | N | LIQUID_DISPENSER_FLOW_BRAKE Claim 1 requires a flow brake with selectable assembly positions and flow resistances that cannot be changed without removing the housing. | — | — | — |
| 9676525 | 2034-02-07 | DP — | N | N | DISPENSER_TWO_POSITION_CAP | — | — | — |
| 9676525 | 2034-02-07 | DP — | N | N | DISPENSER_TWO_POSITION_CAP Claim 1 requires movable inner/outer cap positions, ventilation sealing, an outlet valve and a resilient element blocking return movement. | — | — | — |
| 9669974 | 2034-05-11 | DP — | N | N | DISPENSER_TAMPER_EVIDENT_CAP | — | — | — |
| 9669974 | 2034-05-11 | DP — | N | N | DISPENSER_TAMPER_EVIDENT_CAP Independent claims require inner/outer cap elements, a ventilation channel and an irreversibly removable shut-off segment providing an airtight/germproof closure. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 205894 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-02 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207606 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-01-12 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203880 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-14 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209811 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-21 | — | DEVA HOLDING AS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211943 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-07-05 | — | SAPTALIS PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211909 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-28 | — | AMNEAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209064 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2026-01-21 | — | TWI PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219288 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2026-06-01 | — | JIANGSU ANBISON PHARMACEUTICAL CO LTD | 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 8 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 |
|---|---|---|---|---|---|---|
| 205894 / 001 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207606 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-01-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203880 / 001 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209811 / 001 | DEVA HOLDING AS | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211943 / 001 | SAPTALIS PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2024-07-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211909 / 001 | AMNEAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209064 / 001 | TWI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2026-01-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219288 / 001 | JIANGSU ANBISON PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2026-06-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2031-02-25 | FTO_TAIL | Independent claims require a dispenser housing/reservoir/outlet/air inlet and a removable cap providing specified gas-tight closures. | Source |
| PATENT | 2032-04-16 | FTO_TAIL | Claim 1 requires a flow brake with selectable assembly positions and flow resistances that cannot be changed without removing the housing. | Source |
| PATENT | 2034-02-07 | FTO_TAIL | Claim 1 requires movable inner/outer cap positions, ventilation sealing, an outlet valve and a resilient element blocking return movement. | Source |
| PATENT | 2034-05-11 | FTO_TAIL | Independent claims require inner/outer cap elements, a ventilation channel and an irreversibly removable shut-off segment providing an airtight/germproof closure. | Source |
| REGULATORY_STATUS | 2016-10-27 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. RESTASIS single-use product 001 and RESTASIS MULTIDOSE product 002 share an NDA and concentration but have distinct presentation and TE records. The available AB-rated ANDAs and the Mylan 205894 approval identify RESTASIS, not a verified multidose product-002 reference. Do not transfer EG from single-use to multidose. | 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.