Angiomax Patent Expiration

Angiomax is a drug owned by Sandoz Inc. It is protected by 6 US drug patents filed in 2013. Out of these, 4 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 27, 2029. Details of Angiomax'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5196404 Inhibitors of thrombin
Dec, 2014

(9 years ago)

Expired
US5196404

(Pediatric)

Inhibitors of thrombin
Jun, 2015

(9 years ago)

Expired
US7582727 Pharmaceutical formulations of bivalirudin and processes of making the same
Jul, 2028

(4 years from now)

Active
US7598343 Pharmaceutical formulations of bivalirudin and processes of making the same
Jul, 2028

(4 years from now)

Active
US7582727

(Pediatric)

Pharmaceutical formulations of bivalirudin and processes of making the same
Jan, 2029

(4 years from now)

Active
US7598343

(Pediatric)

Pharmaceutical formulations of bivalirudin and processes of making the same
Jan, 2029

(4 years from now)

Active

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US patents provide insights into the exclusivity only within the United States, but Angiomax 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 Angiomax's family patents as well as insights into ongoing legal events on those patents.

Angiomax's family patents


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Generic Launch

Generic Release Date:

Angiomax's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 27, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Angiomax Generics:

Bivalirudin is the generic name for the brand Angiomax. 10 different companies have already filed for the generic of Angiomax, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Angiomax's generic

How can I launch a generic of Angiomax before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Angiomax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Angiomax'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 Angiomax -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
250 mg/vial 01 Sep, 2009 1 27 Jul, 2028 Extinguished




About Angiomax

Angiomax is a drug owned by Sandoz Inc. It is used for preventing blood clot formation. Angiomax uses Bivalirudin as an active ingredient. Angiomax was launched by Sandoz in 2000.

Market Authorisation Date:

Angiomax was approved by FDA for market use on 15 December, 2000.

Active Ingredient:

Angiomax uses Bivalirudin as the active ingredient. Check out other Drugs and Companies using Bivalirudin ingredient

Treatment:

Angiomax is used for preventing blood clot formation.

Dosage:

Angiomax is available in injectable form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
250MG/VIAL INJECTABLE Prescription INTRAVENOUS