Argatroban In Sodium Chloride is a drug owned by Cipla Ltd. It is protected by 2 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2027. Details of Argatroban In Sodium Chloride'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). | |||
| US7687516 | Alcohol free formulation of argatroban |
Sep, 2027
(3 years from now) | Active |
| US7589106 | Alcohol free formulation of argatroban |
Sep, 2027
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Argatroban In Sodium Chloride's patents.
Latest Legal Activities on Argatroban In Sodium Chloride's Patents
Given below is the list of recent legal activities going on the following patents of Argatroban In Sodium Chloride.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Email Notification | 26 Jul, 2021 | US7687516 |
| Change in Power of Attorney (May Include Associate POA) | 26 Jul, 2021 | US7687516 |
| Email Notification | 26 Jul, 2021 | US7589106 |
| Change in Power of Attorney (May Include Associate POA) | 26 Jul, 2021 | US7589106 |
| Correspondence Address Change | 23 Jul, 2021 | US7589106 |
| Correspondence Address Change | 23 Jul, 2021 | US7687516 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Jul, 2021 | US7687516 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Feb, 2021 | US7589106 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2017 | US7687516 |
| Email Notification | 02 Nov, 2013 | US7687516 |
US patents provide insights into the exclusivity only within the United States, but Argatroban In Sodium Chloride 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 In Sodium Chloride's family patents as well as insights into ongoing legal events on those patents.
Argatroban In Sodium Chloride's family patents
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Generic Launch
Generic Release Date:
Argatroban In Sodium Chloride's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Argatroban In Sodium Chloride Generics:
Argatroban is the generic name for the brand Argatroban In Sodium Chloride. 6 different companies have already filed for the generic of Argatroban In Sodium Chloride, 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 In Sodium Chloride's generic
How can I launch a generic of Argatroban In Sodium Chloride before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Argatroban In Sodium Chloride's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Argatroban In Sodium Chloride'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 In Sodium Chloride -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL, 50 mL vials | 16 Dec, 2011 | 1 | 26 Sep, 2027 | Extinguished |
About Argatroban In Sodium Chloride
Argatroban In Sodium Chloride is a drug owned by Cipla Ltd. It is used for preventing and treating thrombosis. Argatroban In Sodium Chloride uses Argatroban as an active ingredient. Argatroban In Sodium Chloride was launched by Cipla in 2011.
Market Authorisation Date:
Argatroban In Sodium Chloride was approved by FDA for market use on 29 June, 2011.
Active Ingredient:
Argatroban In Sodium Chloride uses Argatroban as the active ingredient. Check out other Drugs and Companies using Argatroban ingredient
Treatment:
Argatroban In Sodium Chloride is used for preventing and treating thrombosis.
Dosage:
Argatroban In Sodium Chloride is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |