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Last Updated: October 6, 2022

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 and Centaur Pharms Pvt, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivabradine hydrochloride has ninety-nine patent family members in forty-three 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.

Recent Clinical Trials for ivabradine hydrochloride

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

SponsorPhase
Uniformed Services University of the Health SciencesPhase 4
Jagiellonian UniversityPhase 3
Vanderbilt University Medical CenterPhase 3

See all ivabradine hydrochloride clinical trials

Generic filers with tentative approvals for IVABRADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing7.5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET;ORAL

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

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
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Centaur Pharms Pvt IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 214051-001 Dec 30, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-001 Apr 15, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Country Patent Number Title Estimated Expiration
Argentina 052926 FORMA CRISTALINA GAMA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES QUE LA CONTIENEN See Plans and Pricing
South Korea 20060095501 beta;-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT See Plans and Pricing
Eurasian Patent Organization 200600322 β-КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРОХЛОРИДА ИВАБРАДИНА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ See Plans and Pricing
Eurasian Patent Organization 008464 β-КРИСТАЛЛИЧЕСКАЯ ФОРМА ГИДРОХЛОРИДА ИВАБРАДИНА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ (BETA-CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT) See Plans and Pricing
Ecuador SP066373 FORMA CRISTALINA BETA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN See Plans and Pricing
Ecuador SP066375 FORMA CRISTALINA GAMMA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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