AGGRASTAT
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
APPROVAL_YEAR_FALLBACK; canonical 2016 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5733919 | 2016-10-23 | DS — | N | N | DP Aqueous tirofiban-class composition requires citrate buffer, pH about5-7 and tonicity-adjusting agent50-500 milliosmoles. Chemical structure inside a composition claim is not standalone drug-substance protection. | — | — | — |
| US5965581 | 2016-10-23 | DP — | N | N | DP Independent tirofiban compositions specify0.25 or0.05 mg/mL, sodium chloride, citrate/citric acid amounts, osmolality and pH5.5-6.5. Exact target is0.25 mg/mL15mL bolus vial, not50 mcg/mL maintenance bag. | — | — | — |
| US5972967 | 2016-10-23 | DP — | N | N | DP Intravenous aqueous tirofiban composition requires citrate buffering and isotonicity adjustment; dependent dose/concentration claims remain formulation-specific. | — | — | — |
| US5978698 | 2017-10-08 | U U-1897 | N | N | U Coronary angioplasty method requires nonionic contrast dye, balloon catheter revascularization and GP IIb/IIIa antagonism. NSTE-ACS label includes patients outside this procedural subset. | — | — | — |
| US6136794 | 2019-01-29 | U U-1898 | N | N | U Platelet-inhibition methods require low-molecular-weight heparin with a GP IIb/IIIa antagonist, optionally aspirin. Label does not require LMWH in all approved AGGRASTAT use. | — | — | — |
| US6770660 | 2023-05-01 | U U-1444 | N | N | U Independent method requires25 mcg/kg tirofiban bolus then0.15 mcg/kg/min for12-72 hours. FDA label includes0.075 mcg/kg/min in CrCl<=60 mL/min and treatment up to18 hours. Dose/population/time restrictions prevent a whole-scope DS-equivalent anchor. | — | — | — |
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. | ||||||||
2026-10-12 · NO_REGULATORY_EXCLUSIVITY_IDENTIFIED · Historical coverage: ANNUALS_2011_2026_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2016-10-23 | FTO_TAIL | Aqueous tirofiban-class composition requires citrate buffer, pH about5-7 and tonicity-adjusting agent50-500 milliosmoles. Chemical structure inside a composition claim is not standalone drug-substance protection. | Source |
| PATENT | 2016-10-23 | FTO_TAIL | Independent tirofiban compositions specify0.25 or0.05 mg/mL, sodium chloride, citrate/citric acid amounts, osmolality and pH5.5-6.5. Exact target is0.25 mg/mL15mL bolus vial, not50 mcg/mL maintenance bag. | Source |
| PATENT | 2016-10-23 | FTO_TAIL | Intravenous aqueous tirofiban composition requires citrate buffering and isotonicity adjustment; dependent dose/concentration claims remain formulation-specific. | Source |
| PATENT | 2017-10-08 | FTO_TAIL | Coronary angioplasty method requires nonionic contrast dye, balloon catheter revascularization and GP IIb/IIIa antagonism. NSTE-ACS label includes patients outside this procedural subset. | Source |
| PATENT | 2019-01-29 | FTO_TAIL | Platelet-inhibition methods require low-molecular-weight heparin with a GP IIb/IIIa antagonist, optionally aspirin. Label does not require LMWH in all approved AGGRASTAT use. | Source |
| PATENT | 2023-05-01 | FTO_TAIL | Independent method requires25 mcg/kg tirofiban bolus then0.15 mcg/kg/min for12-72 hours. FDA label includes0.075 mcg/kg/min in CrCl<=60 mL/min and treatment up to18 hours. Dose/population/time restrictions prevent a whole-scope DS-equivalent anchor. | Source |
| REGULATORY_STATUS | 2016-08-31 | DECISION_BASIS | APPROVAL_YEAR_FALLBACK; canonical 2016 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. | 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.