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Last Updated: December 15, 2024

Mavacamten - Generic Drug Details


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What are the generic sources for mavacamten and what is the scope of patent protection?

Mavacamten is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mavacamten has sixty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for mavacamten
International Patents:67
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 15
Patent Applications: 24
What excipients (inactive ingredients) are in mavacamten?mavacamten excipients list
DailyMed Link:mavacamten at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for mavacamten
Generic Entry Date for mavacamten*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
Dosage:
CAPSULE;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 mavacamten

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

SponsorPhase
Bristol-Myers SquibbPhase 4
Bristol-Myers SquibbPhase 3
Bristol-Myers SquibbPhase 1

See all mavacamten clinical trials

Pharmacology for mavacamten
Anatomical Therapeutic Chemical (ATC) Classes for mavacamten

US Patents and Regulatory Information for mavacamten

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-002 Apr 28, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-002 Apr 28, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-002 Apr 28, 2022 RX Yes Yes RE50050 ⤷  Subscribe Y Y ⤷  Subscribe
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-002 Apr 28, 2022 RX Yes Yes 9,585,883 ⤷  Subscribe ⤷  Subscribe
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-002 Apr 28, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol CAMZYOS mavacamten CAPSULE;ORAL 214998-001 Apr 28, 2022 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 mavacamten

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Camzyos mavacamten EMEA/H/C/005457
Treatment of symptomatic obstructive hypertrophic cardiomyopathy.
Authorised no no no 2023-06-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for mavacamten

Country Patent Number Title Estimated Expiration
Canada 2915967 COMPOSES DE PYRIMIDINE-DIONE CONTRE LES AFFECTIONS CARDIAQUES (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS) ⤷  Subscribe
Brazil 112015031864 compostos de pirimidinadiona contra as condições cardíacas ⤷  Subscribe
Mexico 2021005326 COMPUESTOS DE PIRIMIDINODIONA CONTRA ESTADOS CARDIACOS. (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS.) ⤷  Subscribe
Australia 2022202298 Pyrimidinedione compounds against cardiac conditions ⤷  Subscribe
Japan 2020019809 心臓状態に対するピリミジンジオン化合物 (PYRIMIDINEDIONE COMPOUNDS FOR CARDIAC CONDITIONS) ⤷  Subscribe
Singapore 11201510163T PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for mavacamten

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3010910 C03010910/01 Switzerland ⤷  Subscribe PRODUCT NAME: MAVACAMTENUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68477 25.04.2023
3010910 39/2023 Austria ⤷  Subscribe PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 (MITTTEILUNG) 20230627
3010910 122023000063 Germany ⤷  Subscribe PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 20230626
3010910 LUC00324 Luxembourg ⤷  Subscribe PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627
3010910 301253 Netherlands ⤷  Subscribe PRODUCT NAME: MAVACAMTEN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1716 20230627
3010910 PA2023535 Lithuania ⤷  Subscribe PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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