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, Plano Pharms, Accord Hlthcare, and Eugia Pharma Speclts. and is included in five NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There is one drug master file entry 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 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
Recent Clinical Trials for ARGATROBAN IN SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical University of Vienna | PHASE4 |
| Veralox Therapeutics | Phase 2 |
| 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.
| 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 | 7,687,516 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Plano Pharms | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022485-001 | May 9, 2011 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cipla | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 022434-001 | Jun 29, 2011 | DISCN | Yes | No | 7,589,106 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Gland | ARGATROBAN IN SODIUM CHLORIDE | argatroban | INJECTABLE;INTRAVENOUS | 205570-001 | May 22, 2017 | 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 | ||||
| >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 |
|---|---|---|---|
| Canada | 2669727 | PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) | ⤷ Start Trial |
| China | 101516370 | Alcohol free formulation of argatroban | ⤷ Start Trial |
| European Patent Office | 2083823 | PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) | ⤷ Start Trial |
| Japan | 2010504971 | アルコールを含まないアルガトロバン製剤 | ⤷ Start Trial |
| Japan | 5624766 | ⤷ 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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