BIVALIRUDIN - Generic Drug Details

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What are the generic drug sources for bivalirudin and what is the scope of freedom to operate?

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, Maia Pharms Inc, and Baxter Hlthcare Corp, and is included in fourteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for bivalirudin. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BIVALIRUDIN

US Patents:	5
Tradenames:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	72
Patent Applications:	5,830
Drug Prices:	Drug price trends for BIVALIRUDIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIVALIRUDIN
What excipients (inactive ingredients) are in BIVALIRUDIN?	BIVALIRUDIN excipients list
DailyMed Link:	BIVALIRUDIN at DailyMed

See drug prices for BIVALIRUDIN

Recent Clinical Trials for BIVALIRUDIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sydney Local Health District	Phase 2
Veralox Therapeutics	Phase 2
University Magna Graecia	N/A

See all BIVALIRUDIN clinical trials

Generic filers with tentative approvals for BIVALIRUDIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	250MG/VIAL	INJECTABLE;INTRAVENOUS
⤷ Sign Up	⤷ Sign Up	250MG/VIAL	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BIVALIRUDIN

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

Anatomical Therapeutic Chemical (ATC) Classes for BIVALIRUDIN

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for BIVALIRUDIN

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 BIVALIRUDIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090816-001	Jul 14, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Institutional	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	202471-001	Jun 1, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Slate Run Pharma	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078-001	May 28, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090811-001	Jul 14, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 BIVALIRUDIN

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

EU/EMA Drug Approvals for BIVALIRUDIN

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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