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, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Ph Health, Sandoz, Teva Pharms Usa, Cipla, Plano Pharms, 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. Twelve 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.
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Summary for ARGATROBAN
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 35 |
| 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 |
|---|---|
| Medical University of Vienna | PHASE4 |
| Veralox Therapeutics | Phase 2 |
| Veralox Therapeutics | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Co | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 206698-001 | Jan 26, 2018 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Eugia Pharma Speclts | ARGATROBAN IN SODIUM CHLORIDE | argatroban | SOLUTION;INTRAVENOUS | 209552-001 | Nov 27, 2018 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hospira | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 204120-001 | Sep 21, 2016 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Gland | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 217848-001 | Jul 31, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sandoz | ARGATROBAN IN DEXTROSE | argatroban | SOLUTION;INTRAVENOUS | 201743-001 | May 9, 2011 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 | 5,214,052 | ⤷ Start Trial |
| Sandoz | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | 5,925,760 | ⤷ Start 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 |
|---|---|---|---|
| Germany | 122005000056 | ⤷ Start Trial | |
| Germany | 3866303 | ⤷ Start Trial | |
| European Patent Office | 0301970 | METHOD FOR DISSOLVING ARGININEAMIDES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | ⤷ Start Trial |
| Japan | H0576929 | ⤷ Start Trial | |
| Japan | S6431727 | DISSOLUTION OF ARGININAMIDE AND DRUG COMPOSITION CONTAINING ARGININAMIDES | ⤷ Start Trial |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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