Argatroban is a drug owned by Sandoz Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 30, 2014. Details of Argatroban'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). | |||
| US5214052 | Method for dissolving arginineamides and pharmaceutical compositions containing them |
Jun, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Argatroban 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 Argatroban's family patents as well as insights into ongoing legal events on those patents.
Argatroban's family patents
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Generic Launch
Generic Release Date:
Argatroban's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 30, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Argatroban Generics:
Argatroban is the generic name for the brand Argatroban. 6 different companies have already filed for the generic of Argatroban, with Gland Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Argatroban's generic
How can I launch a generic of Argatroban before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Argatroban's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Argatroban'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 Argatroban -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/mL, 2.5 mL vials | 24 Sep, 2007 | 1 | 30 Jun, 2014 | Extinguished |
About Argatroban
Argatroban is a drug owned by Sandoz Inc. Argatroban uses Argatroban as an active ingredient. Argatroban was launched by Sandoz in 2000.
Market Authorisation Date:
Argatroban was approved by FDA for market use on 30 June, 2000.
Active Ingredient:
Argatroban uses Argatroban as the active ingredient. Check out other Drugs and Companies using Argatroban ingredient
Dosage:
Argatroban is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/2.5ML (100MG/ML) | INJECTABLE | Discontinued | INJECTION |