TIROSINT
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
The existing FDA Final-approved TIROSINT-reference ANDA has an officially approved matching capsule strength; use that exact strength approval date, not the original 75/150 mcg date. 175 mcg: 2023-05-02, ANDA product 006; 200 mcg: 2022-11-09, ANDA product 004. The formulation-restricted patent is retained as an FTO fact and does not reverse EG. Rechecked original ANDA Final approval versus the exact additional-strength dates; the original 2020-10-28 approval is not substituted for either of these later strengths.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 12564565 | 2044-09-26 | DP — | N | N | LOW_IMPURITY_GLYCERIN_THYROXINE_FORMULATION | — | — | — |
| 12564565 | 2044-09-26 | DP — | N | N | LOW_IMPURITY_GLYCERIN_THYROXINE_FORMULATION Claim 1 requires L-thyroxine with vegetable-origin glycerin having specified iron and aldehyde/ketone impurity limits; process claims retain these restrictions. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 211369 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-02 | — | ANI PHARMACEUTICALS INC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211369 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-02 | — | ANI PHARMACEUTICALS INC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211369 / 006 | FINAL_APPROVAL · FINAL_APPROVAL | 2023-05-02 | — | ANI PHARMACEUTICALS INC | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 211369 / 006 | FINAL_APPROVAL · FINAL_APPROVAL | 2023-05-02 | — | ANI PHARMACEUTICALS INC | 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 |
|---|---|---|---|---|---|---|
| 211369 / 006 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-02 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211369 / 006 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-02 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211369 / 006 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVAL | 2023-05-02 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 211369 / 006 | ANI PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVAL | 2023-05-02 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
Decision evidence (3)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2023-05-02 | DISQUALIFYING_FINAL_GENERIC | Exact Final ANDA211369/006 -> NDA021924/011 | Source |
| PATENT | 2044-09-26 | FTO_TAIL | Claim 1 requires L-thyroxine with vegetable-origin glycerin having specified iron and aldehyde/ketone impurity limits; process claims retain these restrictions. | Source |
| REGULATORY_STATUS | 2023-05-02 | DECISION_BASIS | The existing FDA Final-approved TIROSINT-reference ANDA has an officially approved matching capsule strength; use that exact strength approval date, not the original 75/150 mcg date. 175 mcg: 2023-05-02, ANDA product 006; 200 mcg: 2022-11-09, ANDA product 004. The formulation-restricted patent is retained as an FTO fact and does not reverse EG. Rechecked original ANDA Final approval versus the exact additional-strength dates; the original 2020-10-28 approval is not substituted for either of these later strengths. | 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.