Mavacamten - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for mavacamten and what is the scope of freedom to operate?
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-four patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for mavacamten
| International Patents: | 64 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 14 |
| 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:
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
| Sponsor | Phase |
|---|---|
| Bristol-Myers Squibb | Phase 3 |
| Bristol-Myers Squibb | Phase 1 |
| LianBio LLC | Phase 3 |
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 | 214998-001 | Apr 28, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol | CAMZYOS | mavacamten | CAPSULE;ORAL | 214998-003 | Apr 28, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol | CAMZYOS | mavacamten | CAPSULE;ORAL | 214998-002 | Apr 28, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bristol | CAMZYOS | mavacamten | CAPSULE;ORAL | 214998-004 | Apr 28, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 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 |
|---|---|---|---|
| Mexico | 2015017865 | COMPUESTOS DE PIRIMIDINODIONA CONTRA ESTADOS CARDIACOS. (PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS.) | ⤷ Try a Trial |
| Australia | 2018264088 | Pyrimidinedione compounds against cardiac conditions | ⤷ Try a Trial |
| Philippines | 12015502794 | PYRIMIDINEDIONE COMPOUNDS AGAINST CARDIAC CONDITIONS | ⤷ Try a Trial |
| Chile | 2015003689 | Compuestos derivados de 6-(bencil, heteroaril)aminopirimidina-2,4(1h,3h)-diona y sus sales; composicion farmaceutica que los comprende; y su uso para tratar una cardiomiopatia hipertrofica (hcm) o un trastorno cardiaco que tiene una caracteristica patofisiologica asociada con hcm. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for mavacamten
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3010910 | PA2023535 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: MAVAKAMTENAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1716 20230626 |
| 3010910 | 39/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 (MITTTEILUNG) 20230627 |
| 3010910 | CR 2023 00034 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1716 20230627 |
| 3010910 | 122023000063 | Germany | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1716 20230626 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
