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, Bionpharma, Ingenus Pharms Llc, and Zydus Pharms, and is included in five 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. Six suppliers are listed for this compound.

Summary for ivabradine hydrochloride

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	6
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

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
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-001	Dec 30, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-001	Nov 29, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213276-001	Sep 5, 2024	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
Canada	2537400	FORME CRISTALLINE Y DU CHLORHYDRATE DE L'IVABRADINE, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (Y CRYSTALLINE FORM OF IVABRADINE CHLORHYDRATE, PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOUNDS CONTAINING IT)	⤷ Sign Up
Brazil	PI0600796	forma gama-cristalina de cloridrato de ivabradina, processo para preparação do mesmo e composições farmacêuticas contendo o mesmo	⤷ Sign Up
Cuba	23614	FORMA CRISTALINA BETA DEL CLORHIDRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y LAS COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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