AMICAR Drug Patent Profile
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Which patents cover Amicar, and when can generic versions of Amicar launch?
Amicar is a drug marketed by Epic Pharma Llc and Hikma and is included in three NDAs.
The generic ingredient in AMICAR is aminocaproic acid. There are six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amicar
A generic version of AMICAR was approved as aminocaproic acid by LUITPOLD on December 1st, 1987.
Summary for AMICAR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 183 |
| Clinical Trials: | 12 |
| Patent Applications: | 3,297 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMICAR |
| What excipients (inactive ingredients) are in AMICAR? | AMICAR excipients list |
| DailyMed Link: | AMICAR at DailyMed |
Recent Clinical Trials for AMICAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad Autonoma de Nuevo Leon | Phase 2 |
| The University of Texas Health Science Center at San Antonio | Phase 1 |
| Duke University | Phase 4 |
Pharmacology for AMICAR
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased Fibrinolysis |
Anatomical Therapeutic Chemical (ATC) Classes for AMICAR
US Patents and Regulatory Information for AMICAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | AMICAR | aminocaproic acid | INJECTABLE;INJECTION | 015229-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | AMICAR | aminocaproic acid | TABLET;ORAL | 015197-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | AMICAR | aminocaproic acid | SOLUTION;ORAL | 015230-002 | Approved Prior to Jan 1, 1982 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | AMICAR | aminocaproic acid | TABLET;ORAL | 015197-002 | Jun 24, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
