ARGATROBAN IN SODIUM CHLORIDE Drug Patent Profile
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Which patents cover Argatroban In Sodium Chloride, and what generic alternatives are available?
Argatroban In Sodium Chloride is a drug marketed by Cipla, Gland Pharma Ltd, Sandoz, Accord Hlthcare, and Eugia Pharma Speclts. and is included in five NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seven patent family members in five countries.
The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Argatroban In Sodium Chloride
A generic version of ARGATROBAN IN SODIUM CHLORIDE was approved as argatroban by HIKMA PHARM CO LTD on January 5th, 2012.
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Summary for ARGATROBAN IN SODIUM CHLORIDE
| International Patents: | 7 |
| US Patents: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 148 |
| Clinical Trials: | 34 |
| Patent Applications: | 110 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARGATROBAN IN SODIUM CHLORIDE |
| DailyMed Link: | ARGATROBAN IN SODIUM CHLORIDE at DailyMed |
Recent Clinical Trials for ARGATROBAN IN SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Veralox Therapeutics | Phase 2 |
| Veralox Therapeutics | Phase 1 |
| Celerion | Phase 1 |
Pharmacology for ARGATROBAN IN SODIUM CHLORIDE
| Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Paragraph IV (Patent) Challenges for ARGATROBAN IN SODIUM CHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | Injection | argatroban | 1 mg/mL, 50 mL vials | 022434 | 1 | 2011-12-16 |
US Patents and Regulatory Information for ARGATROBAN IN SODIUM CHLORIDE
ARGATROBAN IN SODIUM CHLORIDE is protected by two US patents.
Patents protecting ARGATROBAN IN SODIUM CHLORIDE
Alcohol free formulation of argatroban
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING THROMBOSIS
Alcohol free formulation of argatroban
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022434-001 | Jun 29, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sandoz | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022485-001 | May 9, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cipla | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022434-001 | Jun 29, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Gland Pharma Ltd | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 205570-001 | May 22, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ARGATROBAN IN SODIUM CHLORIDE
See the table below for patents covering ARGATROBAN IN SODIUM CHLORIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2083823 | PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) | ⤷ Sign Up |
| Japan | 2010504971 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2008045410 | ⤷ Sign Up | |
| China | 101516370 | Alcohol free formulation of argatroban | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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