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FDA Orange Book · active-ingredient family

Bupivacaine; meloxicam

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

Reference-listed drug:ZYNRELEF KIT · NDA 211988

1

Brand (NDA)

0

Generics (ANDA)

16

Listed patents

4

Exclusivity periods

Brand (NDA) products · solution, extended release

ProductApplicantApplicationTEApproved
ZYNRELEF KITRLD×4HERON THERAPS INCNDA 211988—May 12, 2021

Marketing exclusivity (4)

  • I-933New indication exclusivity (3 years)

    Jan 23, 2027

    in 7 mo

  • I-933New indication exclusivity (3 years)

    Jan 23, 2027

    in 7 mo

  • I-933New indication exclusivity (3 years)

    Jan 23, 2027

    in 7 mo

  • I-933New indication exclusivity (3 years)

    Jan 23, 2027

    in 7 mo

Listed patents (16)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9592227Mar 13, 2034in 7 yr 10 mo
ProductU-3118
9913909Mar 13, 2034in 7 yr 10 mo
U-3118
11253504Mar 13, 2034in 7 yr 10 mo
U-3118
10398686Mar 13, 2034in 7 yr 10 mo
Product
9744163Mar 13, 2034in 7 yr 10 mo
Product
11413350Apr 20, 2035in 9 yr
U-3417
9694079Apr 20, 2035in 9 yr
ProductU-3118
9801945Apr 20, 2035in 9 yr
ProductU-3118
10213510Apr 20, 2035in 9 yr
ProductU-3118
10098957Apr 20, 2035in 9 yr
U-3118
10632199Apr 20, 2035in 9 yr
ProductU-3118
10898575Apr 20, 2035in 9 yr
ProductU-3118
11083797Apr 20, 2035in 9 yr
ProductU-3118
11083730Apr 20, 2035in 9 yr
ProductU-3118
10980886Apr 20, 2035in 9 yr
Product
11844837Apr 21, 2036in 10 yr
U-3417

Bupivacaine; meloxicam — 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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