ACETAMINOPHEN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
APPROVAL_YEAR_FALLBACK: current product-specific evidence does not establish a DS/DS-equivalent or all-indication exclusivity anchor. Evidence limits: complete comparison of unverified ANDA candidates against original RLD documents remains incomplete; absence of generics is not established; complete historical patent/exclusivity collection remains incomplete.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
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 |
|---|---|---|---|---|---|---|---|
| 204052 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-22 | — | SANDOZ INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202605 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-13 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213255 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-07 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210969 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-21 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214331 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-17 | — | BAXTER HEALTHCARE CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216617 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-07-27 | — | ASPIRO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216467 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-25 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205746 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-04-18 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215403 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-03 | — | INFORLIFE SA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219215 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2025-04-02 | — | GLAND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219096 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-05 | — | CAPLIN STERILES 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 11 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 |
|---|---|---|---|---|---|---|
| 204052 / 001 | SANDOZ INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202605 / 001 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213255 / 001 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210969 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-10-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214331 / 001 | BAXTER HEALTHCARE CORP | FINAL_APPROVAL · FINAL_APPROVED | 2021-09-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216617 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-07-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216467 / 001 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205746 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-04-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 215403 / 001 | INFORLIFE SA | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219215 / 002 | GLAND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-04-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219096 / 001 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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.