Product profile · United States
RYTARY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8377474 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION | — | — | — |
| 8377474 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION | — | — | — |
| 8377474 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION Levodopa/carbidopa multiparticulate controlled/IR and separately coated carboxylic-acid components. | — | — | — |
| 8377474 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION Levodopa/carbidopa multiparticulate controlled/IR and separately coated carboxylic-acid components. | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1646 | N | N | FORMULATION_USE | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1647 | N | N | FORMULATION_USE | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1649 | N | N | FORMULATION_USE | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION_USE | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1649 | N | N | FORMULATION_USE Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1646 | N | N | FORMULATION_USE Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION_USE Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | — | — | — |
| 8454998 | 2028-12-26 | DP/U U-1647 | N | N | FORMULATION_USE Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | — | — | — |
| 8557283 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION_USE | — | — | — |
| 8557283 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE | — | — | — |
| 8557283 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE Levodopa movement-disorder methods require a controlled-release formulation with separate carboxylic-acid bead. | — | — | — |
| 8557283 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION_USE Levodopa movement-disorder methods require a controlled-release formulation with separate carboxylic-acid bead. | — | — | — |
| 9089607 | 2028-12-26 | DP/U U-1720 | N | N | FORMULATION | — | — | — |
| 9089607 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION | — | — | — |
| 9089607 | 2028-12-26 | DP/U U-1720 | N | N | FORMULATION Levodopa multiparticulate formulation with two controlled-release components, IR component and separate enteric-coated acid. | — | — | — |
| 9089607 | 2028-12-26 | DP/U U-1645 | N | N | FORMULATION Levodopa multiparticulate formulation with two controlled-release components, IR component and separate enteric-coated acid. | — | — | — |
| 9089608 | 2028-12-26 | DP — | N | N | FORMULATION | — | — | — |
| 9089608 | 2028-12-26 | DP — | N | N | FORMULATION Controlled-release levodopa/decarboxylase inhibitor with distinct acid bead or a defined plasma concentration profile. | — | — | — |
| 9463246 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE | — | — | — |
| 9463246 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE Parkinson treatment requires multiparticulate carbidopa/levodopa formulation, acid ratio and defined PK profile; not all unrestricted parkinsonism uses. | — | — | — |
| 9533046 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE | — | — | — |
| 9533046 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_USE Parkinson treatment requires multiparticulate formulation with acid/release and detailed PK-profile restrictions. | — | — | — |
| 9901640 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_PK | — | — | — |
| 9901640 | 2028-12-26 | DP/U U-219 | N | N | FORMULATION_PK Independent claim 1 requires carbidopa/levodopa modified release with carboxylic acid ratio and peak-to-trough PK conditions. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NDF | 2015-01-07 | 2018-01-07 | New carbidopa/levodopa extended-release capsule formulation for all approved Parkinson disease and listed secondary parkinsonism uses. | Y | Y | 2018-01-07 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · 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 |
|---|---|---|---|---|---|---|---|
| 208895 / 003 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | SANDOZ INC | 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 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 (17)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-12-26 | FTO_TAIL | Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa/carbidopa multiparticulate controlled/IR and separately coated carboxylic-acid components. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Independent claim 1 requires carbidopa/levodopa modified release with carboxylic acid ratio and peak-to-trough PK conditions. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa/carbidopa multiparticulate controlled/IR and separately coated carboxylic-acid components. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa movement-disorder methods require a controlled-release formulation with separate carboxylic-acid bead. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa multiparticulate formulation with two controlled-release components, IR component and separate enteric-coated acid. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinsonism methods require a specific multiparticulate levodopa/carbidopa/carboxylic-acid formulation; not unrestricted all-scope use protection. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa multiparticulate formulation with two controlled-release components, IR component and separate enteric-coated acid. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinson treatment requires multiparticulate carbidopa/levodopa formulation, acid ratio and defined PK profile; not all unrestricted parkinsonism uses. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Parkinson treatment requires multiparticulate formulation with acid/release and detailed PK-profile restrictions. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Levodopa movement-disorder methods require a controlled-release formulation with separate carboxylic-acid bead. | Source |
| PATENT | 2028-12-26 | FTO_TAIL | Controlled-release levodopa/decarboxylase inhibitor with distinct acid bead or a defined plasma concentration profile. | Source |
| REGULATORY_EXCLUSIVITY | 2018-01-07 | CANONICAL_ANCHOR | New carbidopa/levodopa extended-release capsule formulation for all approved Parkinson disease and listed secondary parkinsonism uses. | Source |
| REGULATORY_STATUS | 2018-01-07 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | 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.