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ARGATROBAN Drug Profile
» See Plans and Pricing
When do Argatroban patents expire, and when can generic versions of Argatroban launch?
Argatroban is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, Gland Pharma Ltd, and Aurobindo Pharma Ltd. and is included in thirteen NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
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.
US ANDA Litigation and Generic Entry Outlook for Argatroban
A generic version of ARGATROBAN was approved as argatroban by NOVARTIS on June 30th, 2000.
Summary for ARGATROBAN
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 13 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 28 |
| Patent Applications: | 141 |
| 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 |
|---|---|
| Weill Medical College of Cornell University | Phase 4 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| Hui-Sheng Chen | N/A |
Pharmacology for ARGATROBAN
| Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Paragraph IV (Patent) Challenges for ARGATROBAN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | INJECTABLE;INTRAVENOUS | argatroban | 022434 | 2011-12-16 |
| ARGATROBAN | INJECTABLE;INJECTION | argatroban | 020883 | 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 | |||
| Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Hikma Pharm Co Ltd | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 203049-001 | Jan 5, 2012 | AP | RX | Yes | Yes | 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 |
|---|---|---|---|---|---|---|---|
| Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
| Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARGATROBAN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0301970 | Start Trial |
| Japan | S6431727 | Start Trial |
| Germany | 122005000056 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
