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FDA Orange Book · active-ingredient family

Amoxicillin; vonoprazan fumarate

Amoxicillin; vonoprazan fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VOQUEZNA DUAL PAK · NDA 215153

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

2

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
VOQUEZNA DUAL PAKRLDPHATHOMNDA 215153—May 03, 2022

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    May 03, 2027

    in 11 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    May 03, 2032

    in 6 yr

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7977488Apr 10, 2030in 3 yr 10 mo
Substance
9186411Aug 11, 2030in 4 yr 2 mo
Product

Amoxicillin; vonoprazan fumarate — frequently asked questions

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

Agent CTA Background

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