NEOSTIGMINE METHYLSULFATE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted DS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. ANDA 207042 references BLOXIVERZ NDA 204078. ANDA 216291 references NDA 203629 but is the 3 mg/3 mL prefilled syringe, not this 5 mg/10 mL vial. Other vial candidate RLD documents were unavailable; DR is retained. Evidence limitation: FDA source documents identifying the direct RLD for remaining matching ANDA candidates.
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. | ||||||||
2026-10-11 · 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 |
|---|---|---|---|---|---|---|---|
| 207042 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-28 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208405 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-04-26 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209933 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-25 | — | AMPHASTAR PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209182 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-05-04 | — | AMERICAN REGENT INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210051 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-06-15 | — | AMNEAL EU LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209135 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-10 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210989 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-08-22 | — | J MOLNER HOLDINGS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212512 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-13 | — | BE PHARMACEUTICALS AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212968 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-16 | — | GLAND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212804 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-05 | — | MEITHEAL PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213074 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-20 | — | CAPLIN STERILES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210652 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-10-01 | — | REGCON HOLDINGS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212627 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-03 | — | NIVAGEN PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208230 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-25 | — | AVET LIFESCIENCES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216542 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-17 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213244 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-11-02 | — | EUGIA PHARMA SPECIALITIES 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 16 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 |
|---|---|---|---|---|---|---|
| 207042 / 001 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-12-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208405 / 001 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-04-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209933 / 001 | AMPHASTAR PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209182 / 001 | AMERICAN REGENT INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-05-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210051 / 001 | AMNEAL EU LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-06-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209135 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210989 / 001 | J MOLNER HOLDINGS INC | FINAL_APPROVAL · FINAL_APPROVED | 2018-08-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212512 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-13 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212968 / 001 | GLAND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212804 / 001 | MEITHEAL PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213074 / 001 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-04-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210652 / 001 | REGCON HOLDINGS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2021-10-01 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212627 / 001 | NIVAGEN PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208230 / 001 | AVET LIFESCIENCES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-11-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216542 / 001 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-02-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213244 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-11-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | 2015-01-08 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted DS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. ANDA 207042 references BLOXIVERZ NDA 204078. ANDA 216291 references NDA 203629 but is the 3 mg/3 mL prefilled syringe, not this 5 mg/10 mL vial. Other vial candidate RLD documents were unavailable; DR is retained. Evidence limitation: FDA source documents identifying the direct RLD for remaining matching ANDA candidates. | 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.