Ivabradine hydrochloride - Generic Drug Details

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What are the generic drug sources for ivabradine hydrochloride and what is the scope of patent protection?

Ivabradine hydrochloride is the generic ingredient in two branded drugs marketed by Amgen Inc, Annora Pharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in four NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivabradine hydrochloride has ninety-seven patent family members in forty-two countries.

There are eight drug master file entries for ivabradine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ivabradine hydrochloride

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	80
Patent Applications:	378
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivabradine hydrochloride
DailyMed Link:	ivabradine hydrochloride at DailyMed

Recent Clinical Trials for ivabradine hydrochloride

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

Sponsor	Phase
Second Affiliated Hospital of Guangzhou Medical University	Phase 4
Uniformed Services University of the Health Sciences	Phase 4
The Young Investigator Group of Cardiovascular Research	Phase 3

See all ivabradine hydrochloride clinical trials

Generic filers with tentative approvals for IVABRADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	7.5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET;ORAL

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 ivabradine hydrochloride

Drug Class	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ivabradine hydrochloride

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for IVABRADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CORLANOR	Tablets	ivabradine hydrochloride	5 mg and 7.5 mg	206143	6	2019-10-15

US Patents and Regulatory Information for ivabradine hydrochloride

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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
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-001	Dec 30, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-002	Nov 29, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ivabradine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Uruguay	29405	FORMA CRISTALINA BETA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTINEN.	⤷ Sign Up
Argentina	053147	FORMA CRISTALINA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES FARMACEUTICAS QUE LA CONTIENEN	⤷ Sign Up
Japan	4625776		⤷ Sign Up
European Patent Office	1707562	Forme cristalline gamma du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutique qui la contiennent (Crystalline form gamma of the chlorhydrate of ivabradine, process for its preparation and pharamcetuical composition containing it)	⤷ Sign Up
Japan	2006241154	beta-CRYSTAL FORM OF IVABRADINE HYDROCHLORIDE, METHOD FOR PRODUCING THE SAME AND MEDICINAL COMPOSITION CONTAINING THE SAME	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006092492		⤷ Sign Up
Singapore	125229	Gamma-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceuticalcompositions containing it	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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