Product profile · United States
ABSORICA LD
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Discontinued in the original 2026-10-10 source. Actual marketing-discontinuation date is unverified. Evidence limits: actual discontinuation date unavailable; do not substitute the observation date or approval year.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9750711 | 2035-05-29 | DP — | — | — | — [GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | — | — | — |
| 9750711 | 2035-05-29 | DP — | — | — | — Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | — | — | — |
| 9700535 | 2035-08-04 | DP — | — | — | — [GNR_US204_50] Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | — | — | — |
| 9700535 | 2035-08-04 | DP — | — | — | — Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 075945 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2002-11-08 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076041 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2002-12-24 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076135 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2003-04-11 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 076485 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2012-01-19 | — | UPSHER SMITH LABORATORIES LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202099 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2013-03-25 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207792 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-29 | — | AMNEAL PHARMACEUTICALS OF NY LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205063 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | — | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212333 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-21 | — | UPSHER SMITH LABORATORIES LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211568 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-29 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218194 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-29 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216633 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-05-22 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216097 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-10-07 | — | AMNEAL PHARMACEUTICALS OF NY LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 220336 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2026-09-10 | — | AUROBINDO PHARMA 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 13 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 |
|---|---|---|---|---|---|---|
| 075945 / 002 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2002-11-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076041 / 002 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2002-12-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076135 / 002 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2003-04-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 076485 / 002 | UPSHER SMITH LABORATORIES LLC | FINAL_APPROVAL · FINAL_APPROVED | 2012-01-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202099 / 002 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-03-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207792 / 002 | AMNEAL PHARMACEUTICALS OF NY LLC | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205063 / 002 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212333 / 002 | UPSHER SMITH LABORATORIES LLC | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211568 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218194 / 002 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-01-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216633 / 002 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-05-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216097 / 002 | AMNEAL PHARMACEUTICALS OF NY LLC | FINAL_APPROVAL · FINAL_APPROVED | 2025-10-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 220336 / 001 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2026-09-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2035-05-29 | LISTING_CONTEXT | Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | Source |
| PATENT | 2035-08-04 | LISTING_CONTEXT | Not used as a canonical patent anchor for the DISCONTINUED decision; does not establish complete claim verification. | 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.