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ANGIOMAX Drug Profile
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When do Angiomax patents expire, and when can generic versions of Angiomax launch?
Angiomax is a drug marketed by Sandoz Inc and Maia Pharms Inc and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
US ANDA Litigation and Generic Entry Outlook for Angiomax
A generic version of ANGIOMAX was approved as bivalirudin by HOSPIRA INC on July 14th, 2015.
Summary for ANGIOMAX
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 12 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ANGIOMAX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANGIOMAX |
| DailyMed Link: | ANGIOMAX at DailyMed |
Recent Clinical Trials for ANGIOMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Legacy Health System | Phase 4 |
| Pacific University | Phase 4 |
| Qian Gong | Phase 2 |
Pharmacology for ANGIOMAX
| Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Paragraph IV (Patent) Challenges for ANGIOMAX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ANGIOMAX | INJECTABLE;INTRAVENOUS | bivalirudin | 020873 | 2009-09-01 |
US Patents and Regulatory Information for ANGIOMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz Inc | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Sandoz Inc | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | 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 ANGIOMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz Inc | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANGIOMAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69231081 | Start Trial |
| Spain | 2149170 | Start Trial |
| Finland | 120690 | Start Trial |
| Singapore | 79180 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ANGIOMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0489070 | 22/2004 | Austria | Start Trial | PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920 |
| 0489070 | 300162 | Netherlands | Start Trial | PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920 |
| 0489070 | SPC/GB04/035 | United Kingdom | Start Trial | PRODUCT NAME: H-(D-PHE)-PRO-ARG-PRO-(GLY)4-ASN-GLY-ASP-PHE-GLU-GLU-ILE-PRO-GLU-GLU-TYR-LEU-OH, OPTIONALLY IN THE FORM OF ITS PHARMACEUTICALLY ACCEPTABLE SALT (BIVALIRUDIN); REGISTERED: UK EU/1/04/289/001 20040920 |
| 0489070 | CA 2004 00032 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
