ANGIOMAX Drug Patent Profile

When do Angiomax patents expire, and when can generic versions of Angiomax launch?

Angiomax is a drug marketed by Sandoz and Maia Pharms Inc and is included in two NDAs. There are five 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. Fifteen 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 FRESENIUS KABI USA on October 28^th, 2016.

Summary for ANGIOMAX

US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	19
Patent Applications:	4,423
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

See drug prices 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

See all ANGIOMAX clinical trials

Pharmacology for ANGIOMAX

Drug Class	Anti-coagulant Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

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	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes

Expired US Patents for ANGIOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000

EU/EMA Drug Approvals for ANGIOMAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
The Medicines Company UK Ltd	Angiox	bivalirudin	EMEA/H/C/000562 Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.	Withdrawn	no	no	no	2004-09-20

International Patents for ANGIOMAX

See the table below for patents covering ANGIOMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0768141
Hungary	211158
South Korea	100199534
Finland	102183

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0489070	SPC/GB04/035	United Kingdom		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	22/2004	Austria		PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
0489070	CA 2004 00032	Denmark
0489070	300162	Netherlands		PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920