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CORLANOR Drug Patent 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 and one Paragraph IV challenge.

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. Two suppliers are listed for this compound. Additional details are available on the ivabradine hydrochloride profile page.

DrugPatentWatch^® 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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Summary for CORLANOR

International Patents:	99
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	6
Patent Applications:	920
Drug Prices:	Drug price information for CORLANOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CORLANOR
What excipients (inactive ingredients) are in CORLANOR?	CORLANOR excipients list
DailyMed Link:	CORLANOR at DailyMed

Drug patent expirations by year for CORLANOR

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for CORLANOR

Generic Entry Dates for CORLANOR^: ⤷ Sign up for a Free Trial* Constraining patent/regulatory exclusivity: INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE NDA: 209964 Dosage: SOLUTION;ORAL
Generic Entry Dates for CORLANOR^: ⤷ Sign up for a Free Trial* Constraining patent/regulatory exclusivity: ⤷ Sign up for a Free Trial NDA: 206143 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

Sponsor	Phase
Amgen	Phase 3
iRhythm Technologies, Inc.	Phase 4
Phillip Levy	Phase 4

See all CORLANOR clinical trials

Pharmacology for CORLANOR

Drug Class	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Mechanism of Action	Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CORLANOR

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

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

CORLANOR is protected by eight US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CORLANOR is ⤷ Sign up for a Free Trial.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CORLANOR

.beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: A METHOD FOR TREATING HEART FAILURE IN A HUMAN USING A CRYSTALLINE FORM OF IVABRADINE HYDROCHLORIDE

FDA Regulatory Exclusivity protecting CORLANOR

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign up for a Free Trial

INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE
Exclusivity Expiration: ⤷ Sign up for a Free Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign up for a Free Trial

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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	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial	Y	Y		⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial				⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial	Y	Y		⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-001	Apr 15, 2015		RX	Yes	No	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial			Y	⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine	SOLUTION;ORAL	209964-001	Apr 22, 2019		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial				⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial			Y	⤷ Sign up for a Free Trial
Amgen Inc	CORLANOR	ivabradine hydrochloride	TABLET;ORAL	206143-002	Apr 15, 2015		RX	Yes	Yes	⤷ Sign up for a Free Trial	⤷ Sign up for a Free Trial			Y	⤷ Sign up for a Free 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 CORLANOR

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Country	Patent Number	Estimated Expiration
France	2882553	⤷ Sign up for a Free Trial
New Zealand	545578	⤷ Sign up for a Free Trial
Malaysia	158128	⤷ Sign up for a Free Trial
European Patent Office	1695965	⤷ Sign up for a Free Trial
Slovenia	1707562	⤷ Sign up for a Free Trial
Costa Rica	8248	⤷ Sign up for a Free Trial
Eurasian Patent Organization	008464	⤷ Sign up for a Free Trial
>Country	>Patent Number	>Estimated Expiration