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Last Updated: January 27, 2021

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CORLANOR Drug Profile

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Which patents cover Corlanor, and what generic alternatives are available?

Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. There are eight patents protecting this drug.

This drug has ninety-nine patent family members in forty-three countries.

The generic ingredient in CORLANOR 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.

US ANDA Litigation and Generic Entry Outlook for Corlanor

Corlanor was eligible for patent challenges on April 15, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 22, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for CORLANOR
Drug Prices for CORLANOR

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Generic Entry Opportunity Date for CORLANOR
Generic Entry Dates for CORLANOR*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for CORLANOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CORLANOR

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

SponsorPhase
AmgenPhase 3
iRhythm Technologies, Inc.Phase 4
Phillip LevyPhase 4

See all CORLANOR clinical trials

Paragraph IV (Patent) Challenges for CORLANOR
Tradename Dosage Ingredient NDA Submissiondate
CORLANOR TABLET;ORAL ivabradine hydrochloride 206143 2019-10-15

US Patents and Regulatory Information for CORLANOR

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 SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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