ARGATROBAN Drug Patent Profile
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When do Argatroban patents expire, and when can generic versions of Argatroban launch?
Argatroban is a drug marketed by Amneal Pharms Co, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Par Sterile Products, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts. and is included in sixteen NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in ARGATROBAN 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
A generic version of ARGATROBAN was approved as argatroban by HIKMA PHARM CO LTD on January 5th, 2012.
Summary for ARGATROBAN
US Patents: | 0 |
Applicants: | 13 |
NDAs: | 16 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 34 |
Patent Applications: | 117 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ARGATROBAN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARGATROBAN |
What excipients (inactive ingredients) are in ARGATROBAN? | ARGATROBAN excipients list |
DailyMed Link: | ARGATROBAN at DailyMed |
Recent Clinical Trials for ARGATROBAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Veralox Therapeutics | Phase 2 |
Veralox Therapeutics | Phase 1 |
Celerion | Phase 1 |
Pharmacology for ARGATROBAN
Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
Mechanism of Action | Thrombin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ARGATROBAN
Paragraph IV (Patent) Challenges for ARGATROBAN
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 |
ARGATROBAN | Injection | argatroban | 100 mg/mL, 2.5 mL vials | 020883 | 1 | 2007-09-24 |
US Patents and Regulatory Information for ARGATROBAN
Expired US Patents for ARGATROBAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARGATROBAN
See the table below for patents covering ARGATROBAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | S6431727 | DISSOLUTION OF ARGININAMIDE AND DRUG COMPOSITION CONTAINING ARGININAMIDES | ⤷ Try a Trial |
Spain | 2166937 | ⤷ Try a Trial | |
European Patent Office | 0823430 | Procédé pour la préparation de N2-arylsulfonyl-L-arginamides (Method for preparing n2-arylsulfonyl-l-argininamides) | ⤷ Try a Trial |
Germany | 122005000056 | ⤷ Try a Trial | |
Germany | 69707603 | ⤷ Try a Trial | |
Germany | 3866303 | ⤷ Try a Trial | |
Japan | H0576929 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |