FDA Orange Book · active-ingredient family
Eptifibatide
Eptifibatide: 1 brand, 15 generics; first approved May 18, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
15
Listed patents
0
Presentations
29
Brand (NDA) products
Originator applications
- INTEGRILINRLDMSD SUB MERCKNDA 02071819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- EPTIFIBATIDEMEITHEALANDA 21359920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDESHUANGCHENGANDA 21308120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDEHYBIOANDA 20786420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDEUSVANDA 20436120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDEUSVANDA 2043622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDESLATE RUN PHARMAANDA 20986420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDEBAXTER HLTHCARE CORPANDA 20855420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDERSMYLAN LABS LTDANDA 20325820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDESAGENT PHARMS INCANDA 20469320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDEACCORD HLTHCAREANDA 20555720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDERISINGANDA 20458920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDEAMNEAL PHARMSANDA 20558120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — 75MG/100ML INJECTABLE INJECTION Discontinued — - EPTIFIBATIDEEUGIA PHARMAANDA 20612720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP 75MG/100ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDETEVA PHARMS USAANDA 0908542015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - EPTIFIBATIDETEVA PHARMS USAANDA 0915552015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG/100ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
28 yr 8 mo ago
Most recent approval
2 yr 4 mo ago
Approvals span 1998–2024 across 16 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1594%
Eptifibatide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
