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FDA Orange Book · active-ingredient family

Landiolol hydrochloride

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

Reference-listed drug:RAPIBLYK · NDA 217202

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

2

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
RAPIBLYKRLDAOP HLTH USNDA 217202—Nov 22, 2024

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Nov 22, 2029

    in 3 yr 6 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 13, 2029

    in 2 yr 8 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10722516Apr 25, 2034in 8 yr
U-4235

Landiolol 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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