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FDA Orange Book · active-ingredient family

Acoramidis hydrochloride

Acoramidis hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ATTRUBY · NDA 216540

1

Brand (NDA)

0

Generics (ANDA)

13

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ATTRUBYRLDBRIDGEBIO PHARMANDA 216540—Nov 22, 2024

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Nov 22, 2029

    in 3 yr 6 mo

  • ODE-506Orphan-drug exclusivity (7 years)

    Nov 22, 2031

    in 5 yr 6 mo

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9169214May 05, 2031in 4 yr 11 mo
ProductU-4046
9913826May 05, 2031in 4 yr 11 mo
U-4046
10842777May 05, 2031in 4 yr 11 mo
U-4046
10398681May 05, 2031in 4 yr 11 mo
Product
9642838May 05, 2031in 4 yr 11 mo
SubstanceProduct
8877795May 05, 2031in 4 yr 11 mo
Product
11919865Feb 16, 2038in 11 yr 10 mo
U-4046
10513497Feb 16, 2038in 11 yr 10 mo
Substance
11058668Mar 22, 2039in 12 yr 11 mo
U-4046
12070449Mar 22, 2039in 12 yr 11 mo
U-4046
12005043Aug 16, 2039in 13 yr 4 mo
ProductU-4046
12539290Aug 16, 2039in 13 yr 4 mo
Product
11260047Aug 16, 2039in 13 yr 4 mo
Product

Acoramidis hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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