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Last Updated: April 18, 2024

IVABRADINE HYDROCHLORIDE - Generic Drug Details

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

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. One supplier is 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:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	79
Patent Applications:	403
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
⤷ Try a Trial	⤷ Try a Trial	7.5MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-001	Oct 5, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
China	1827600	Crystalline form beta of the chlorhydrate of ivabradine, process for its preparation and pharamcetuical composition containing it	⤷ Try a Trial
Norway	20060946		⤷ Try a Trial
Colombia	5770097	FORMA CRISTALINA GAMMA DEL CLORHITRATO DE LA IVABRADINA, SU PROCEDIMIENTO DE PREPARACION Y LAS COMPOSICIONES FARMACEUTICAS QUE LAS CONTIENEN	⤷ Try a Trial
New Zealand	545576	Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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