Integrilin is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 5 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2015. Details of Integrilin's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5807825 | Platelet aggregation inhibitors |
Sep, 2015
(9 years ago) |
Expired
|
| US5968902 | Platelet aggregation inhibitors |
Jun, 2015
(9 years ago) |
Expired
|
| US5747447 | Stable polypeptide composition |
May, 2015
(9 years ago) |
Expired
|
| US5756451 | Platelet aggregation inhibitors |
Nov, 2014
(10 years ago) |
Expired
|
| US5686570 | Platelet aggregation inhibitors |
Nov, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Integrilin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Integrilin's family patents as well as insights into ongoing legal events on those patents.
Integrilin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Integrilin's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 15, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Integrilin Generic API suppliers:
Eptifibatide is the generic name for the brand Integrilin. 13 different companies have already filed for the generic of Integrilin, with Usv having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Integrilin's generic
How can I launch a generic of Integrilin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Integrilin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Integrilin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Integrilin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg/mL, 10 mL vial | 30 Sep, 2008 | 1 | 12 Jun, 2015 | 15 Sep, 2015 | Extinguished |
| 2 mg/mL, 100 mL vial | 18 Dec, 2008 | 1 | 12 Jun, 2015 | 15 Sep, 2015 | Extinguished |
About Integrilin
Integrilin is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for preventing blood clot formation in patients with platelet-associated ischemic disorders. Integrilin uses Eptifibatide as an active ingredient. Integrilin was launched by Msd Sub Merck in 1998.
Approval Date:
Integrilin was approved by FDA for market use on 18 May, 1998.
Active Ingredient:
Integrilin uses Eptifibatide as the active ingredient. Check out other Drugs and Companies using Eptifibatide ingredient
Treatment:
Integrilin is used for preventing blood clot formation in patients with platelet-associated ischemic disorders.
Dosage:
Integrilin is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |