Product profile · United States
BIORPHEN
· 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 215268 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | NEPHRON | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210334 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-04-27 | — | MEITHEAL PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211079 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-05 | — | AMNEAL EU LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210025 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-21 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210665 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-29 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208905 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-31 | — | SANDOZ INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209967 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-01-16 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213318 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-06-11 | — | CAPLIN STERILES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213237 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-01 | — | ACCORD HEALTHCARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211081 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-17 | — | MILLA PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210696 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-01-07 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211920 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-08 | — | GLAND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217069 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-30 | — | MANKIND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209968 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-28 | — | AVET LIFESCIENCES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217521 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-26 | — | BE PHARMACEUTICALS AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218412 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-14 | — | HAINAN POLY PHARM CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218110 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-10 | — | ASPIRO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217032 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2026-04-03 | — | BAXTER HEALTHCARE CORP | 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 17 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 |
|---|---|---|---|---|---|---|
| 210334 / 001 | MEITHEAL PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-04-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211079 / 001 | AMNEAL EU LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210025 / 001 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210665 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208905 / 001 | SANDOZ INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-01-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209967 / 001 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-01-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213318 / 001 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213237 / 001 | ACCORD HEALTHCARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211081 / 001 | MILLA PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-07-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210696 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-01-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211920 / 003 | GLAND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217069 / 001 | MANKIND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209968 / 001 | AVET LIFESCIENCES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217521 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2023-06-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218412 / 001 | HAINAN POLY PHARM CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-03-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218110 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-05-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217032 / 001 | BAXTER HEALTHCARE CORP | FINAL_APPROVAL · FINAL_APPROVED | 2026-04-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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.