MIRAPEX ER
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. All seven MIRAPEX ER strengths are currently discontinued. Matching generic approvals are historical facts and do not override the current-product status.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7695734 | 2028-04-26 | DP — | N | N | EXTENDED_RELEASE_MATRIX | — | — | — |
| 7695734 | 2028-04-26 | DP — | N | N | EXTENDED_RELEASE_MATRIX Claim 1 requires two specified hydrophilic polymers, excludes pregelatinized starch, and imposes pH dependent release behavior. | — | — | — |
| 8679533 | 2029-09-08 | DP/U U-219 | N | N | EXTENDED_RELEASE_FORMULATION | — | — | — |
| 8679533 | 2029-09-08 | DP/U U-219 | N | N | EXTENDED_RELEASE_FORMULATION Claim 1 requires starch and hydrophilic polymer proportions plus dissolution or absorption and clinical response limitations. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 202206 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2014-02-06 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202353 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2014-12-04 | — | CHARTWELL RX SCIENCES LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203354 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-07 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 201963 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2016-04-21 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206156 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-24 | — | MACLEODS PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202891 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-12-12 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204518 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-02 | — | ALEMBIC PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212797 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-11 | — | XIAMEN LP PHARMACUETICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213444 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-03 | — | NOVAST LABORATORIES 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 9 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 |
|---|---|---|---|---|---|---|
| 202206 / 002 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-02-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202353 / 002 | CHARTWELL RX SCIENCES LLC | FINAL_APPROVAL · FINAL_APPROVED | 2014-12-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203354 / 002 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 201963 / 002 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-04-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206156 / 002 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202891 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-12-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204518 / 002 | ALEMBIC PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212797 / 002 | XIAMEN LP PHARMACUETICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213444 / 002 | NOVAST LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-02-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-04-26 | FTO_TAIL | Claim 1 requires two specified hydrophilic polymers, excludes pregelatinized starch, and imposes pH dependent release behavior. | Source |
| PATENT | 2029-09-08 | FTO_TAIL | Claim 1 requires starch and hydrophilic polymer proportions plus dissolution or absorption and clinical response limitations. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. All seven MIRAPEX ER strengths are currently discontinued. Matching generic approvals are historical facts and do not override the current-product status. | 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.