Product profile · United States
ALSUMA (AUTOINJECTOR)
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
NDA 022377 approval withdrawal effective 2017-07-21. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7811254 | 2027-08-26 | DP/U U-1083 | N | N | DEVICE | — | — | — |
| 7811254 | 2027-08-26 | DP/U U-1083 | N | N | DEVICE Autoinjector assembly, needle-depth adapter and injection mechanics; not sumatriptan molecule or all-indication method protection. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 077332 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | PH HEALTH | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077871 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | PH HEALTH | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077907 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | TEVA PHARMS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078067 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | SANDOZ | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078318 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | TEVA PARENTERAL | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078319 / 002 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ANTARES PHARMA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 078593 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | WOCKHARDT BIO AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079123 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | HIKMA PHARMS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079240 / 002 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | FRESENIUS KABI USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 079242 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | FRESENIUS KABI USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090310 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ZYDUS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090314 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ONESOURCE SPECIALTY | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090314 / 002 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ONESOURCE SPECIALTY | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090358 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | SUN PHARM | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090495 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | DR REDDYS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090641 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ONESOURCE SPECIALTY | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 200183 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | HIKMA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202758 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | EUGIA PHARMA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203322 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | PHARMOBEDIENT | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207101 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | BAXTER HLTHCARE CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213518 / 002 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ALEMBIC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213998 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | CAPLIN | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 215651 / 001 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | ONESOURCE SPECIALTY | 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 0 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 |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-08-26 | FTO_TAIL | Autoinjector assembly, needle-depth adapter and injection mechanics; not sumatriptan molecule or all-indication method protection. | Source |
| REGULATORY_STATUS | 2017-07-21 | TERMINAL_STATUS | NDA 022377 approval withdrawal effective 2017-07-21. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status. | 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.