ARGATROBAN - Generic Drug Details
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What are the generic sources for argatroban and what is the scope of patent protection?
Argatroban
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Argatroban has seven patent family members in five countries.
There are eleven drug master file entries for argatroban. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ARGATROBAN
International Patents: | 7 |
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 13 |
NDAs: | 16 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 34 |
Patent Applications: | 243 |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for ARGATROBAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 250MG/250ML | INJECTABLE; INJECTION |
⤷ Sign Up | ⤷ Sign Up | 100MG | INJECTABLE; INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Sandoz | ARGATROBAN IN DEXTROSE | argatroban | SOLUTION;INTRAVENOUS | 201743-001 | May 9, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mylan Institutional | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 202626-001 | Jun 30, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | ARGATROBAN IN 0.9% SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 206769-001 | Dec 15, 2014 | DISCN | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARGATROBAN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2008039473 | ⤷ Sign Up | |
Japan | 2010504971 | ⤷ Sign Up | |
Japan | 5624766 | ⤷ Sign Up | |
China | 101516370 | Alcohol free formulation of argatroban | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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