Product profile · United States
GOCOVRI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA first-generic table specifies ANDA 214897 approval on 2024-08-26 for GOCOVRI 68.5 mg. Exclude the earlier 2022 tentative-approval date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8389578 | 2028-01-22 | U U-2105 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 8389578 | 2028-01-22 | U U-2105 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE PD levodopa/carbidopa IR plus amantadine ER 200-500 mg with dC/dT limitations. | — | — | — |
| 11197835 | 2030-12-02 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11197835 | 2030-12-02 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE PD levodopa dyskinesia, bedtime 0-4 hours, and specified PK. | — | — | — |
| 8741343 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK | — | — | — |
| 8741343 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK Amantadine 220-445 mg at bedtime with Tmax 8-18 hours/Cmax/AUC limitations. | — | — | — |
| 9867791 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK | — | — | — |
| 9867791 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK Amantadine 250-600 mg at bedtime with release/PK limitations. | — | — | — |
| 9867792 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK | — | — | — |
| 9867792 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK Amantadine 220-455 mg bedtime unit dose with PK limitations. | — | — | — |
| 9867793 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK | — | — | — |
| 9867793 | 2030-12-02 | U U-2106 | N | N | FORMULATION_OR_PK Independent LID and general amantadine-administration claims also require 220-455 mg at bedtime and pellet coating. | — | — | — |
| 9877933 | 2030-12-02 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 9877933 | 2030-12-02 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE PD ON without troublesome dyskinesia·220–455mg bedtime PK | — | — | — |
| 10646456 | 2034-06-17 | U U-2808 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10646456 | 2034-06-17 | U U-2808 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Levodopa-treated PD OFF/ON improvement with specified amantadine titration. | — | — | — |
| 11903908 | 2034-06-17 | U U-3822 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11903908 | 2034-06-17 | U U-3822 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Levodopa-treated PD OFF: initial 85-170 mg followed by 300-380 mg titration. | — | — | — |
| 10154971 | 2034-12-04 | U U-2459 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 10154971 | 2034-12-04 | U U-2459 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE PD OFF time: first-week 85-170 mg followed by 260-380 mg titration; coverage of every 68.5 mg renal-maintenance regimen is unproven. | — | — | — |
| 11065213 | 2038-08-23 | DP — | N | N | FORMULATION_OR_PK | — | — | — |
| 11065213 | 2038-08-23 | DP — | N | N | FORMULATION_OR_PK Amantadine 50-500 mg ER with specified dissolution at 2/4/6/12 hours. | — | — | — |
| 11077073 | 2038-08-23 | U U-3180 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11077073 | 2038-08-23 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11077073 | 2038-08-23 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 11077073 | 2038-08-23 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | — | — | — |
| 11077073 | 2038-08-23 | U U-3180 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | — | — | — |
| 11077073 | 2038-08-23 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | — | — | — |
| 12233033 | 2038-08-23 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 12233033 | 2038-08-23 | U U-3180 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 12233033 | 2038-08-23 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE | — | — | — |
| 12233033 | 2038-08-23 | U U-3180 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Improvement of LID/ON/OFF in LID patients with specified release. | — | — | — |
| 12233033 | 2038-08-23 | U U-2224 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Improvement of LID/ON/OFF in LID patients with specified release. | — | — | — |
| 12233033 | 2038-08-23 | U U-2106 | N | N | POPULATION_OR_INDICATION_RESTRICTED_USE Improvement of LID/ON/OFF in LID patients with specified release. | — | — | — |
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. | ||||||||
2026-10-10 · 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 |
|---|---|---|---|---|---|---|---|
| 214897 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-26 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214897 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-26 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214897 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-08-26 | — | ZYDUS WORLDWIDE DMCC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 214897 / 001 | FINAL_APPROVAL · FINAL_APPROVAL | 2024-08-26 | — | ZYDUS WORLDWIDE DMCC | 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 |
|---|---|---|---|---|---|---|
| 214897 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-26 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214897 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVED | 2024-08-26 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214897 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVAL | 2024-08-26 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 214897 / 001 | ZYDUS WORLDWIDE DMCC | FINAL_APPROVAL · FINAL_APPROVAL | 2024-08-26 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (18)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2024-08-26 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA214897/001 -> NDA208944/001 | Source |
| PATENT | 2028-01-22 | FTO_TAIL | PD levodopa/carbidopa IR plus amantadine ER 200-500 mg with dC/dT limitations. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | Amantadine 220-445 mg at bedtime with Tmax 8-18 hours/Cmax/AUC limitations. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | Amantadine 220-455 mg bedtime unit dose with PK limitations. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | Independent LID and general amantadine-administration claims also require 220-455 mg at bedtime and pellet coating. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | Amantadine 250-600 mg at bedtime with release/PK limitations. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | PD levodopa dyskinesia, bedtime 0-4 hours, and specified PK. | Source |
| PATENT | 2030-12-02 | FTO_TAIL | PD ON without troublesome dyskinesia·220–455mg bedtime PK | Source |
| PATENT | 2034-06-17 | FTO_TAIL | Levodopa-treated PD OFF: initial 85-170 mg followed by 300-380 mg titration. | Source |
| PATENT | 2034-06-17 | FTO_TAIL | Levodopa-treated PD OFF/ON improvement with specified amantadine titration. | Source |
| PATENT | 2034-12-04 | FTO_TAIL | PD OFF time: first-week 85-170 mg followed by 260-380 mg titration; coverage of every 68.5 mg renal-maintenance regimen is unproven. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Improvement of LID/ON/OFF in LID patients with specified release. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Amantadine 50-500 mg ER with specified dissolution at 2/4/6/12 hours. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Improvement of LID/ON/OFF in LID patients with specified release. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Improvement of LID/ON/OFF in LID patients with specified release. | Source |
| PATENT | 2038-08-23 | FTO_TAIL | Requires PD patients with levodopa-induced dyskinesia; excludes OFF patients without LID. | 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.