IVABRADINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Ivabradine Hydrochloride, and what generic alternatives are available?

Ivabradine Hydrochloride is a drug marketed by Annora Pharma, Ingenus Pharms Llc, and Zydus Pharms. and is included in three NDAs.

The generic ingredient in IVABRADINE HYDROCHLORIDE is ivabradine hydrochloride. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ivabradine Hydrochloride

A generic version of IVABRADINE HYDROCHLORIDE was approved as ivabradine hydrochloride by ANNORA PHARMA on October 5^th, 2022.

Summary for IVABRADINE HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	79
Patent Applications:	224
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-001	Oct 5, 2022	AB	RX	No	No
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-002	Dec 30, 2021		DISCN	No	No
Annora Pharma	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213366-002	Oct 5, 2022	AB	RX	No	No
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	214051-001	Dec 30, 2021		DISCN	No	No
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-002	Nov 29, 2023	AB	RX	No	No
Zydus Pharms	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	TABLET;ORAL	213442-001	Nov 29, 2023	AB	RX	No	No