ANGIOMAX Drug Patent 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. Twelve suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 18 |
Patent Applications: | 5,514 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ANGIOMAX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANGIOMAX |
What excipients (inactive ingredients) are in ANGIOMAX? | ANGIOMAX excipients list |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for ANGIOMAX
Paragraph IV (Patent) Challenges for ANGIOMAX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ANGIOMAX | For Injection | bivalirudin | 250 mg/vial | 020873 | 1 | 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Sandoz Inc | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANGIOMAX
See the table below for patents covering ANGIOMAX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2079778 | INHIBITEURS DE LA THROMBINE (INHIBITORS OF THROMBIN) | See Plans and Pricing |
Germany | 69026715 | See Plans and Pricing | |
Luxembourg | 91119 | See Plans and Pricing | |
Hong Kong | 1001562 | See Plans and Pricing | |
Australia | 659828 | See Plans and Pricing | |
South Korea | 100199534 | See Plans and Pricing | |
Singapore | 79180 | NOVEL INHIBITORS OF THROMBIN | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANGIOMAX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0489070 | 22/2004 | Austria | See Plans and Pricing | PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920 |
0489070 | CA 2004 00032 | Denmark | See Plans and Pricing | |
0489070 | SPC/GB04/035 | United Kingdom | See Plans and Pricing | 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 | 300162 | Netherlands | See Plans and Pricing | PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920 |
0489070 | 91119 | Luxembourg | See Plans and Pricing | 91119, EXPIRES: 20150817 |
0489070 | C00489070/01 | Switzerland | See Plans and Pricing | FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |