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.
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: | 128 |
Formulation / Manufacturing: | see details |
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 |
Celerion | Phase 1 |
Veralox Therapeutics | Phase 1 |
Pharmacology for ARGATROBAN IN SODIUM CHLORIDE
Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
Mechanism of Action | Thrombin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ARGATROBAN IN SODIUM CHLORIDE
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING THROMBOSIS
Alcohol free formulation of argatroban
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Sandoz | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022485-001 | May 9, 2011 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cipla | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022434-001 | Jun 29, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gland Pharma Ltd | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 205570-001 | May 22, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 |
---|---|---|---|
China | 101516370 | Alcohol free formulation of argatroban | ⤷ Try a Trial |
European Patent Office | 2083823 | PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2008039473 | ⤷ Try a Trial | |
Japan | 5624766 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |