Home / Generic availability / Eptifibatide
When will generic Eptifibatide be available?
The FDA lists no patents or exclusivity for eptifibatide, and 15 generic applications are already approved, so generic eptifibatide is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| INTEGRILIN | Brand (NDA) | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC | 1998-05-18 | reference listed drug |
| EPTIFIBATIDE | Generic (ANDA) | TEVA PHARMACEUTICALS USA | 2015-06-12 | |
| EPTIFIBATIDE | Generic (ANDA) | TEVA PHARMACEUTICALS USA | 2015-06-05 | |
| EPTIFIBATIDE | Generic (ANDA) | MYLAN LABORATORIES LTD | 2018-07-20 | reference standard |
| EPTIFIBATIDE | Generic (ANDA) | USV PRIVATE LTD | 2019-03-14 | |
| EPTIFIBATIDE | Generic (ANDA) | USV PRIVATE LTD | 2019-03-11 | |
| EPTIFIBATIDE | Generic (ANDA) | RISING PHARMA HOLDINGS INC | 2017-04-18 | |
| EPTIFIBATIDE | Generic (ANDA) | SAGENT PHARMACEUTICALS INC | 2018-03-07 | |
| EPTIFIBATIDE | Generic (ANDA) | ACCORD HEALTHCARE INC | 2017-11-06 | |
| EPTIFIBATIDE | Generic (ANDA) | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 2016-12-08 | |
| EPTIFIBATIDE | Generic (ANDA) | EUGIA PHARMA SPECIALITIES LTD | 2015-12-08 | |
| EPTIFIBATIDE | Generic (ANDA) | HYBIO PHARMACEUTICAL CO LTD | 2020-03-20 | |
| EPTIFIBATIDE | Generic (ANDA) | BAXTER HEALTHCARE CORP | 2018-11-23 | |
| EPTIFIBATIDE | Generic (ANDA) | HAINAN POLY PHARM CO LTD | 2019-01-25 | |
| EPTIFIBATIDE | Generic (ANDA) | QUAGEN PHARMACEUTICALS LLC | 2021-09-07 | |
| EPTIFIBATIDE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2024-05-09 |
What a generic Eptifibatide would have to match
Forms and strengths
Injection: 20 mg of eptifibatide injection in 10 mL (2 mg/mL), for intravenous bolus. Injection: 75 mg of eptifibatide injection in 100 mL (0.75 mg/mL), for intravenous infusion. 20 mg/10 mL (2 mg/mL) in a single-dose vial for bolus injection. ( 3 ) 75 mg/100 mL (0.75 mg/mL) in a single-dose vial for infusion. ( 3 )
How it is supplied
16.1 How Supplied Eptifibatide injection is supplied as a sterile solution in 10 mL vials containing 20 mg of eptifibatide (NDC 70436-162-80) and 100 mL vials containing 75 mg of eptifibatide (NDC 70436-163-80). 16.2 Storage Vials should be stored refrigerated at 2° to 8°C (36° to 46°F). Vials may be transferred to room temperature storage* for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a “DISCARD BY” date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration. *Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-02-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Ganirelixno patent or exclusivity listed
- Goserelinno patent or exclusivity listed
- Icatibantno patent or exclusivity listed
- Oxytocinno patent or exclusivity listed
- Pramlintideno patent or exclusivity listed
Frequently asked questions
When will generic Eptifibatide be available?
The FDA lists no patents or exclusivity for eptifibatide, and 15 generic applications are already approved, so generic eptifibatide is available in the United States.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
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