MINOLIRA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA approval of this entire NDA and its strengths was withdrawn effective 2026-04-08. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11103517 | 2036-04-07 | DP — | N | N | PELLET_TABLET_FORMULATION | — | — | — |
| 11103517 | 2036-04-07 | DP — | N | N | PELLET_TABLET_FORMULATION Independent claims 1 and 5 restrict 105 mg and 135 mg minocycline tablets to specified immediate and extended release pellets, cores, polymers, and dissolution attributes. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 090422 / 008 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | SANDOZ | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203443 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-08-22 | — | RISING PHARMA HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091118 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-25 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204394 / 005 | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-30 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202261 / 007 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-13 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204453 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2016-09-28 | — | ALKEM LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 065485 / 008 | FINAL_APPROVAL · FINAL_APPROVED | 2017-04-26 | — | BARR LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203553 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-16 | — | ZYDUS PHARMACEUTICALS USA 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 7 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 |
|---|---|---|---|---|---|---|
| 203443 / 003 | RISING PHARMA HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-08-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091118 / 006 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-09-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204394 / 005 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202261 / 007 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204453 / 004 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-09-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 065485 / 008 | BARR LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-04-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203553 / 006 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2036-04-07 | FTO_TAIL | Independent claims 1 and 5 restrict 105 mg and 135 mg minocycline tablets to specified immediate and extended release pellets, cores, polymers, and dissolution attributes. | Source |
| REGULATORY_STATUS | 2026-04-08 | TERMINAL_STATUS | FDA approval of this entire NDA and its strengths was withdrawn effective 2026-04-08. This legal notice supersedes the discontinued-list classification. Rereview corrected Discontinued to WITHDRAWN and recorded the actual FDA effective date. The notice publication date is not substituted for a later effective date. | 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.