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ANGIOMAX Drug Profile
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See Plans and PricingWhich patents cover Angiomax, 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
Recent Clinical Trials for ANGIOMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pacific University | Phase 4 |
| Legacy Health System | Phase 4 |
| Qian Gong | Phase 2 |
Recent Litigation for ANGIOMAX
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Medicines Company v. Hospira, Inc. | 2014-05-13 |
| The Medicines Company v. Exela Pharma Sciences, LLC | 2014-04-25 |
| THE MEDICINES COMPANY v. AUROBINDO PHARMA LIMITED | 2014-04-11 |
Pharmacology for ANGIOMAX
| Drug Class | Anti-coagulant Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Synonyms for ANGIOMAX
| (R,R)-2,6-Bis(4,5-dihydro-4-phenyl-2-oxazolyl)pyridine; (R,R)-2,6-Bis(4-phenyl-2-oxazolinyl)pyridine; (+)-2,6-Bis[(4R)-4-phenyl-2-oxazolin-2-yl]pyridine |
| 1191386-55-6 |
| 128270-60-0 |
| 270B600 |
| 70B600 |
| AKOS015994644 |
| AN-7543 |
| Angiox |
| BC657176 |
| BG 8967 |
| BG-8967 |
| BG8967 |
| Bivalirudin |
| Bivalirudin [USAN:BAN:INN] |
| Bivalirudin [USAN:INN:BAN] |
| Bivalirudin Trifluoacetate |
| Bivalirudin Trifluoroacetate |
| Bivalirudin;0.9% Sodium Chloride |
| bivalirudina |
| bivalirudine |
| bivalirudinum |
| C98H138N24O33 |
| C9H11NO.C2H6.CH4 |
| CHEBI:59173 |
| CHEMBL2103749 |
| DB00006 |
| EBD32115 |
| GTPL6470 |
| Hirulog |
| Hirulog-1 |
| HS-2004 |
| J-005587 |
| KS-00002WUN |
| LS-172701 |
| MolPort-006-167-455 |
| Phe-Pro-Arg-Pro-(Gly)4 desulfato-Tyr63'-hirugen |
| Phe-Pro-Arg-Pro-(Gly)4-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu |
| Phe-Pro-Arg-Pro-(Gly)4-desulfohirudin-(53-64) |
| SCHEMBL25739 |
| TN9BEX005G |
| UNII-TN9BEX005G |
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 |
