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Last Updated: March 19, 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 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. One supplier is 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
Second Affiliated Hospital of Guangzhou Medical UniversityPhase 4
Uniformed Services University of the Health SciencesPhase 4
The Young Investigator Group of Cardiovascular ResearchPhase 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 Trial7.5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial5MGTABLET;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
Annora Pharma IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 213366-002 Oct 5, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
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
Ingenus Pharms Llc IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 214051-001 Dec 30, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Ingenus Pharms Llc IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 214051-002 Dec 30, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms IVABRADINE HYDROCHLORIDE ivabradine hydrochloride TABLET;ORAL 213442-002 Nov 29, 2023 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

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) ⤷  Try a Trial
Norway 338481 ⤷  Try a Trial
Portugal 1707562 ⤷  Try a Trial
Uruguay 29406 FORMA CRISTALINA GAMMA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN. ⤷  Try a Trial
Norway 338370 ⤷  Try a Trial
Japan 2006241156 gamma-CRYSTAL FORM OF IVABRADINE HYDROCHLORIDE, METHOD FOR PRODUCING THE SAME AND MEDICINAL COMPOSITION CONTAINING THE SAME ⤷  Try a Trial
Guatemala 200600084 FORMA CRISTALINA BETA DE CLORHIDRATO DE IVABRADINA, SU PROCEDIMIENTO DE PREPARACIÓN Y COMPOSICIONES FARMACÉUTICAS QUE LA CONTIENEN ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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