CORLANOR Drug Patent Profile
✉ Email this page to a colleague
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-seven patent family members in forty-two 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Corlanor
A generic version of CORLANOR was approved as ivabradine hydrochloride by ANNORA PHARMA on October 5th, 2022.
Summary for CORLANOR
International Patents: | 97 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 6 |
Patent Applications: | 209 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CORLANOR
Generic Entry Date for CORLANOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 |
Pharmacology for CORLANOR
Anatomical Therapeutic Chemical (ATC) Classes for CORLANOR
Paragraph IV (Patent) Challenges for CORLANOR
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 CORLANOR
CORLANOR is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CORLANOR is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
.gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting CORLANOR
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: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | ||
Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for CORLANOR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Accord Healthcare S.L.U. | Ivabradine Accord | ivabradine | EMEA/H/C/004241 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.Ivabradine is indicated :- in adults unable to tolerate or with a contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. (see section 5.1) |
Authorised | yes | no | no | 2017-05-22 | |
Zentiva, k.s. | Ivabradine Zentiva | ivabradine | EMEA/H/C/004117 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | yes | no | no | 2016-11-11 | |
Les Laboratoires Servier | Corlentor | ivabradine | EMEA/H/C/000598 Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | no | no | no | 2005-10-25 | |
Les Laboratoires Servier | Procoralan | ivabradine | EMEA/H/C/000597 Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
Authorised | no | no | no | 2005-10-25 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CORLANOR
When does loss-of-exclusivity occur for CORLANOR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 07
Estimated Expiration: ⤷ Try a Trial
Patent: 56
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 2926
Estimated Expiration: ⤷ Try a Trial
Patent: 3147
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 06200856
Estimated Expiration: ⤷ Try a Trial
Patent: 06200857
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 96974
Estimated Expiration: ⤷ Try a Trial
Patent: 07926
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0600623
Estimated Expiration: ⤷ Try a Trial
Patent: 0600796
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 37400
Estimated Expiration: ⤷ Try a Trial
Patent: 37414
Estimated Expiration: ⤷ Try a Trial
China
Patent: 27600
Estimated Expiration: ⤷ Try a Trial
Patent: 27602
Estimated Expiration: ⤷ Try a Trial
Patent: 0402502
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 70096
Estimated Expiration: ⤷ Try a Trial
Patent: 70097
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 48
Estimated Expiration: ⤷ Try a Trial
Patent: 49
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0080406
Estimated Expiration: ⤷ Try a Trial
Patent: 0080520
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 614
Estimated Expiration: ⤷ Try a Trial
Patent: 616
Estimated Expiration: ⤷ Try a Trial
Patent: 060037
Estimated Expiration: ⤷ Try a Trial
Patent: 060039
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 09010
Estimated Expiration: ⤷ Try a Trial
Patent: 09072
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 95965
Estimated Expiration: ⤷ Try a Trial
Patent: 07562
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 066373
Estimated Expiration: ⤷ Try a Trial
Patent: 066375
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8464
Estimated Expiration: ⤷ Try a Trial
Patent: 8465
Estimated Expiration: ⤷ Try a Trial
Patent: 0600320
Estimated Expiration: ⤷ Try a Trial
Patent: 0600322
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 95965
Estimated Expiration: ⤷ Try a Trial
Patent: 07562
Estimated Expiration: ⤷ Try a Trial
France
Patent: 82553
Estimated Expiration: ⤷ Try a Trial
Patent: 82555
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0084465
Estimated Expiration: ⤷ Try a Trial
Patent: 0084467
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2006001312
Estimated Expiration: ⤷ Try a Trial
Patent: 2006002624
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0600084
Estimated Expiration: ⤷ Try a Trial
Patent: 0600088
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 96387
Estimated Expiration: ⤷ Try a Trial
Patent: 96659
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 25776
Estimated Expiration: ⤷ Try a Trial
Patent: 28974
Estimated Expiration: ⤷ Try a Trial
Patent: 06241154
Estimated Expiration: ⤷ Try a Trial
Patent: 06241156
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 15
Estimated Expiration: ⤷ Try a Trial
Patent: 48
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8128
Estimated Expiration: ⤷ Try a Trial
Patent: 8129
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 408
Estimated Expiration: ⤷ Try a Trial
Patent: 747
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 131
Estimated Expiration: ⤷ Try a Trial
Patent: 134
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5576
Estimated Expiration: ⤷ Try a Trial
Patent: 5578
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 8370
Estimated Expiration: ⤷ Try a Trial
Patent: 8481
Estimated Expiration: ⤷ Try a Trial
Patent: 060946
Estimated Expiration: ⤷ Try a Trial
Patent: 060948
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 061009
Estimated Expiration: ⤷ Try a Trial
Patent: 061142
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 95965
Estimated Expiration: ⤷ Try a Trial
Patent: 07562
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 95965
Estimated Expiration: ⤷ Try a Trial
Patent: 07562
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 270038
Estimated Expiration: ⤷ Try a Trial
Patent: 270040
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 598
Estimated Expiration: ⤷ Try a Trial
Patent: 661
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 5228
Estimated Expiration: ⤷ Try a Trial
Patent: 5229
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 95965
Estimated Expiration: ⤷ Try a Trial
Patent: 07562
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0601762
Estimated Expiration: ⤷ Try a Trial
Patent: 0601764
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 0827502
Estimated Expiration: ⤷ Try a Trial
Patent: 0835447
Estimated Expiration: ⤷ Try a Trial
Patent: 060095499
Estimated Expiration: ⤷ Try a Trial
Patent: 060095501
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 08689
Estimated Expiration: ⤷ Try a Trial
Patent: 13581
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 14143
Estimated Expiration: ⤷ Try a Trial
Patent: 14144
Estimated Expiration: ⤷ Try a Trial
Patent: 0640872
Estimated Expiration: ⤷ Try a Trial
Patent: 0640873
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 904
Estimated Expiration: ⤷ Try a Trial
Patent: 595
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 405
Estimated Expiration: ⤷ Try a Trial
Patent: 406
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering CORLANOR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | E407926 | ⤷ Try a Trial | |
Brazil | PI0600623 | forma beta-cristalina de cloridrato de ivabradina, processo para preparação do mesmo e composições farmacêuticas contendo o mesmo | ⤷ Try a Trial |
Taiwan | I314144 | ⤷ Try a Trial | |
Germany | 602006002624 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |