Details for New Drug Application (NDA): 216540
✉ Email this page to a colleague
NDA 216540 describes ATTRUBY, which is a drug marketed by Bridgebio Pharma and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ATTRUBY profile page.
The generic ingredient in ATTRUBY is acoramidis hydrochloride. One supplier is listed for this compound. Additional details are available on the acoramidis hydrochloride profile page.
The generic ingredient in ATTRUBY is acoramidis hydrochloride. One supplier is listed for this compound. Additional details are available on the acoramidis hydrochloride profile page.
Summary for 216540
| Tradename: | ATTRUBY |
| Applicant: | Bridgebio Pharma |
| Ingredient: | acoramidis hydrochloride |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216540
Generic Entry Date for 216540*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS(ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR DEATH AND CARDIOVASCULAR-RELATED HOSPITALIZATION 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.
Pharmacology for NDA: 216540
| Mechanism of Action | Cytochrome P450 2C9 Inhibitors Transthyretin Stabilizers |
Suppliers and Packaging for NDA: 216540
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATTRUBY | acoramidis hydrochloride | TABLET;ORAL | 216540 | NDA | BridgeBio Pharma, Inc. | 82228-712 | 82228-712-28 | 4 DOSE PACK in 1 CARTON (82228-712-28) / 1 BLISTER PACK in 1 DOSE PACK / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 356MG BASE | ||||
| Approval Date: | Nov 22, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 22, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 22, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS(ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR DEATH AND CARDIOVASCULAR-RELATED HOSPITALIZATION | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 5, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
