MAVACAMTEN - Generic Drug Details
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What are the generic 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 |
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 | 214998-002 | Apr 28, 2022 | RX | Yes | Yes | ⤷ 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 | Y | Y | ⤷ 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 | 214998-001 | 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 |
|---|---|---|---|
| Israel | 243222 | תרכובת פירימידינדיאון נגד הפרעות לבביות (Pyrimidinedione compounds against cardiac conditions) | ⤷ Try a Trial |
| Australia | 2018264088 | Pyrimidinedione compounds against cardiac conditions | ⤷ Try a Trial |
| Japan | 2016522263 | 心臓状態に対するピリミジンジオン化合物 | ⤷ Try a Trial |
| Eurasian Patent Organization | 201690066 | СОЕДИНЕНИЯ ПИРИМИДИНДИОНА | ⤷ Try a Trial |
| Japan | 7376556 | ⤷ 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 | 301253 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1716 20230627 |
| 3010910 | LUC00324 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627 |
| 3010910 | 2023C/546 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MAVACAMTEN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1716 20230627 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
