Corlanor is a drug owned by Amgen Inc. It is protected by 8 US drug patents filed from 2015 to 2019 out of which none have expired yet. Corlanor's patents have been open to challenges since 16 October, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 12, 2027. Details of Corlanor's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7867996 | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Dec, 2026
(2 years from now) | Active |
| US7879842 | Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
| US7361649 | β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
| US7361650 | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7867996 (Pediatric) | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Jun, 2027
(2 years from now) | Active |
|
US7361649 (Pediatric) | β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Aug, 2026
(1 year, 9 months from now) | Active |
|
US7879842 (Pediatric) | Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Aug, 2026
(1 year, 9 months from now) | Active |
|
US7361650 (Pediatric) | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Aug, 2026
(1 year, 9 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Corlanor's patents.
Latest Legal Activities on Corlanor's Patents
Given below is the list of recent legal activities going on the following patents of Corlanor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jul, 2022 | US7879842 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2022 | US7867996 |
| Patent Term Extension Certificate Critical | 06 Dec, 2021 | US7867996 |
| Notice of Final Determination -Election Required | 08 Feb, 2021 | US7867996 |
| Notice of Final Determination -Election Required | 08 Feb, 2021 | US7879842 |
| Post Issue Communication - Certificate of Correction | 22 Sep, 2020 | US7879842 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jul, 2019 | US7361650 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jul, 2019 | US7361649 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jan, 2019 | US7361649 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jan, 2019 | US7361650 |
FDA has granted several exclusivities to Corlanor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Corlanor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Corlanor.
Exclusivity Information
Corlanor holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Corlanor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 15, 2020 |
| Pediatric Exclusivity(PED) | Oct 22, 2026 |
| New Product(NP) | Apr 22, 2022 |
| Orphan Drug Exclusivity(ODE-234) | Apr 22, 2026 |
US patents provide insights into the exclusivity only within the United States, but Corlanor is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Corlanor's family patents as well as insights into ongoing legal events on those patents.
Corlanor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Corlanor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Corlanor Generics:
There are no approved generic versions for Corlanor as of now.
How can I launch a generic of Corlanor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Corlanor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Corlanor's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Corlanor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 7.5 mg | 15 Oct, 2019 | 6 | 30 Dec, 2021 | 22 Feb, 2026 | Eligible |
About Corlanor
Corlanor is a drug owned by Amgen Inc. It is used for treating heart failure in humans. Corlanor uses Ivabradine Hydrochloride as an active ingredient. Corlanor was launched by Amgen Inc in 2015.
Approval Date:
Corlanor was approved by FDA for market use on 15 April, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Corlanor is 15 April, 2015, its NCE-1 date is estimated to be 16 October, 2019.
Active Ingredient:
Corlanor uses Ivabradine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ivabradine Hydrochloride ingredient
Treatment:
Corlanor is used for treating heart failure in humans.
Dosage:
Corlanor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 7.5MG BASE | TABLET | Prescription | ORAL |
| EQ 5MG BASE | TABLET | Prescription | ORAL |
Corlanor is a drug owned by Amgen Inc. It is protected by 4 US drug patents filed in 2019 out of which none have expired yet. Corlanor's patents will be open to challenges from 22 October, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 12, 2026. Details of Corlanor's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7867996 | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Dec, 2026
(2 years from now) | Active |
| US7361650 | γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
| US7361649 | β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
| US7879842 | Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
Feb, 2026
(1 year, 3 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Corlanor's patents.
Latest Legal Activities on Corlanor's Patents
Given below is the list of recent legal activities going on the following patents of Corlanor.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jul, 2022 | US7879842 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2022 | US7867996 |
| Patent Term Extension Certificate Critical | 06 Dec, 2021 | US7867996 |
| Notice of Final Determination -Election Required | 08 Feb, 2021 | US7867996 |
| Notice of Final Determination -Election Required | 08 Feb, 2021 | US7879842 |
| Post Issue Communication - Certificate of Correction | 22 Sep, 2020 | US7879842 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jul, 2019 | US7361650 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jul, 2019 | US7361649 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jan, 2019 | US7361649 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jan, 2019 | US7361650 |
FDA has granted several exclusivities to Corlanor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Corlanor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Corlanor.
Exclusivity Information
Corlanor holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Corlanor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 15, 2020 |
| Pediatric Exclusivity(PED) | Oct 22, 2026 |
| New Product(NP) | Apr 22, 2022 |
| Orphan Drug Exclusivity(ODE-234) | Apr 22, 2026 |
US patents provide insights into the exclusivity only within the United States, but Corlanor is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Corlanor's family patents as well as insights into ongoing legal events on those patents.
Corlanor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Corlanor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 12, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Corlanor Generics:
There are no approved generic versions for Corlanor as of now.
About Corlanor
Corlanor is a drug owned by Amgen Inc. It is used for treating heart failure in humans. Corlanor uses Ivabradine as an active ingredient. Corlanor was launched by Amgen Inc in 2019.
Approval Date:
Corlanor was approved by FDA for market use on 22 April, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Corlanor is 22 April, 2019, its NCE-1 date is estimated to be 22 October, 2025.
Active Ingredient:
Corlanor uses Ivabradine as the active ingredient. Check out other Drugs and Companies using Ivabradine ingredient
Treatment:
Corlanor is used for treating heart failure in humans.
Dosage:
Corlanor is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/5ML (1MG/ML) | SOLUTION | Prescription | ORAL |