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CORLANOR Drug Profile
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» See Plans and PricingWhich 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
Summary for CORLANOR
| International Patents: | 99 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 115 |
| Clinical Trials: | 5 |
| Patent Applications: | 363 |
| Drug Prices: | Drug price information for CORLANOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CORLANOR |
| DailyMed Link: | CORLANOR at DailyMed |
Generic Entry Opportunity Date for CORLANOR
Generic Entry Dates for CORLANOR*:
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:
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
| Sponsor | Phase |
|---|---|
| Amgen | Phase 3 |
| iRhythm Technologies, Inc. | Phase 4 |
| Phillip Levy | Phase 4 |
Recent Litigation for CORLANOR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| AMGEN INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2020-01-21 |
Pharmacology for CORLANOR
Synonyms for CORLANOR
| (7,8-Dimethoxy 3-(3-(((1S)-(4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2H-benzazepin-2-one hydrochloride |
| (S)-3-(3-(((3,4-Dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one |
| (S)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one hydrochloride |
| (S)-3-(3-(((3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1H-benzo[d]azepin-2(3H)-one hydrochloride |
| 148849-67-6 |
| 155974-00-8 |
| 185824-EP2276742A1 |
| 2H-3-Benzazepin-2-one, 3-(3-((((7S)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, monohydrochloride |
| 2H-3-Benzazepin-2-one, 3-(3-(((3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, (S)- |
| 2H-3-Benzazepin-2-one, 3-(3-(((3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, monohydrochloride, (S)- |
| 2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-, hydrochloride (1:1) |
| 3-(3-((((7S)-3,4-Dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one |
| 3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one |
| 3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one hydrochloride |
| 3-[3-[[(8S)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one |
| 3-[3-[[(8S)-3,4-Dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride |
| 3-[3-[[(8S)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one hydrochloride3-[3-[[(8S)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3, |
| 3-[3-[[[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one Hydrochloride |
| 3-{3-[[(3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl](methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-3-benzazepin-2-one |
| 3-{3-[{[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one hydrochloride |
| 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)-amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one |
| 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]-propyl}-7.8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one |
| 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one |
| 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one--hydrogen chloride (1/1) |
| 3H48L0LPZQ |
| 7-(3-((((R)-4,5-dimethoxy-1,2-dihydrocyclobutabenzen-1-yl)methyl)(methyl)amino)propyl)-2,3-dimethoxy-8,9-dihydro-5H-benzo[7]annulen-6(7H)-one |
| 7,8-Dimethoxy-3-(3-(((4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2H-benzazepin-2-one |
| 974I008 |
| AB0011288 |
| AB01566878_01 |
| AC-543 |
| AC-8848 |
| ACRHBAYQBXXRTO-OAQYLSRUSA-N |
| AK-46411 |
| AKOS015849582 |
| AKOS015896494 |
| AKOS016002249 |
| AM20090729 |
| AMG-998 |
| AOB4729 |
| API0000615 |
| API0006402 |
| AR-270/43507923 |
| AX8135490 |
| B1360 |
| BCP05218 |
| BCP21052 |
| BCP9000798 |
| BDBM50326992 |
| C27H36N2O5 |
| C27H37ClN2O5 |
| CAS-148849-67-6 |
| CHEBI:85966 |
| CHEBI:85969 |
| CHEMBL2145077 |
| CHEMBL471737 |
| CI0043 |
| Corlanor (TN) |
| Corlentor |
| Corlentor (TN) |
| CS-1994 |
| CTK8E8827 |
| D07165 |
| D08095 |
| DB09083 |
| DSSTox_CID_26913 |
| DSSTox_GSID_46913 |
| DSSTox_RID_82011 |
| DTXSID2046913 |
| DTXSID2048240 |
| FT-0659345 |
| FT-0697755 |
| GS-3584 |
| GTPL2357 |
| HLUKNZUABFFNQS-ZMBIFBSDSA-N |
| HY-B0162A |
| I0847 |
| Ivabradine |
| Ivabradine (hydrochloride) |
| Ivabradine (USAN/INN) |
| Ivabradine [INN] |
| Ivabradine [USAN:INN:BAN] |
| Ivabradine HCl |
| Ivabradine HCl (Procoralan) |
| Ivabradine hydrochloride |
| Ivabradine hydrochloride (JAN) |
| Ivabradine hydrochloride [USAN] |
| Ivabradine hydrochloride, >=98% (HPLC) |
| ivabradine monohydrochloride |
| ivabradine-hcl-procoralan |
| IvabradineHCl |
| Ivabrandine hydrochloride |
| J-008523 |
| J-521616 |
| KS-000004OB |
| LS-28023 |
| LS-28024 |
| MLS006010110 |
| N-{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}-3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-3-benzazepin-3-yl)-N-methylpropan-1-aminium chloride |
| NCGC00181343-01 |
| Procoralan |
| Q27158823 |
| Q425729 |
| RTC-070922 |
| S 16257 |
| S 16257-2 |
| S-16257 |
| S-16257-2 |
| S-16260-2 |
| s16257 |
| s2086 |
| SB12484 |
| SB12485 |
| SC-20079 |
| SC-83347 |
| SCHEMBL23470 |
| SCHEMBL23472 |
| SMR004701246 |
| ST24036090 |
| TC-070922 |
| Tox21_112802 |
| TP19837BZK |
| UNII-3H48L0LPZQ |
| UNII-C8ADC441ME component ACRHBAYQBXXRTO-OAQYLSRUSA-N |
| UNII-TP19837BZK |
| V0092 |
| ZINC3805768 |
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 | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ecuador | SP066373 | Start Trial |
| China | 1827600 | Start Trial |
| Serbia | 50661 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
