Baxdrostat - Generic Drug Details
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What are the generic sources for baxdrostat and what is the scope of freedom to operate?
Baxdrostat
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for baxdrostat
| International Patents: | 40 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| Patent Applications: | 9 |
| What excipients (inactive ingredients) are in baxdrostat? | baxdrostat excipients list |
| DailyMed Link: | baxdrostat at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for baxdrostat
Generic Entry Date for baxdrostat*:
Constraining patent/regulatory exclusivity:
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 baxdrostat
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | PHASE2 |
| AstraZeneca | PHASE1 |
| AstraZeneca | PHASE3 |
Anatomical Therapeutic Chemical (ATC) Classes for baxdrostat
US Patents and Regulatory Information for baxdrostat
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BAXFENDY | baxdrostat | TABLET;ORAL | 219878-001 | May 15, 2026 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Astrazeneca Ab | BAXFENDY | baxdrostat | TABLET;ORAL | 219878-001 | May 15, 2026 | RX | Yes | No | 9,353,081 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Astrazeneca Ab | BAXFENDY | baxdrostat | TABLET;ORAL | 219878-002 | May 15, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Astrazeneca Ab | BAXFENDY | baxdrostat | TABLET;ORAL | 219878-002 | May 15, 2026 | RX | Yes | Yes | 9,353,081 | ⤷ Start Trial | Y | Y | ⤷ 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 baxdrostat
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 087984 | DERIVADOS BICICLICOS DE DIHIDROQUINOLINA-2-ONA | ⤷ Start Trial |
| Australia | 2012311582 | New bicyclic dihydroquinoline-2-one derivatives | ⤷ Start Trial |
| Brazil | 112014006660 | novos derivados de dihidroquinolina-2-ona bicíclicos | ⤷ Start Trial |
| Canada | 2845170 | NOUVEAUX DERIVES BICYCLIQUES DE DIHYDROQUINOLINE-2-ONE (NEW BICYCLIC DIHYDROQUINOLINE-2-ONE DERIVATIVES) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
