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Orange Book product · Brand (NDA)

Auvi-q

Epinephrine

Brand (NDA)NDA 201739TE BXRLD Kaleo Inc
Approved
Aug 10, 2012
Application
Brand (NDA)
TE code
BX
Listed patents
9
Auvi-q (Epinephrine) is Kaleo Inc's brand-name drug, approved by the FDA under NDA 201739 in 2012. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is BX — a code beginning with B means it is not rated therapeutically equivalent. 11 approved generics share this drug's active ingredient. The FDA Orange Book lists 9 patents against it, the last expiring 2037.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 10, 2012

    14 yr 1 mo ago

  2. Today

  3. Patent 11590286 expires

    Listed drug product patent expiration.

    Dec 12, 2026

    in 5 mo

  4. Patent 8206360 expires

    Listed drug product patent expiration.

    Feb 27, 2027

    in 8 mo

  5. Patent 7947017 expires

    Listed drug product patent expiration.

    Mar 12, 2028

    in 1 yr 8 mo

  6. Patent 8231573 expires

    Listed drug product patent expiration.

    Nov 25, 2028

    in 2 yr 5 mo

  7. Patent 8226610 expires

    Listed drug product patent expiration.

    Apr 10, 2029

    in 2 yr 9 mo

  8. Patent 8021344 expires

    Listed drug product patent expiration.

    Nov 02, 2029

    in 3 yr 4 mo

  9. Patent 10688244 expires

    Listed drug product patent expiration.

    Dec 21, 2037

    in 11 yr 7 mo

  10. Patent 10842938 expires

    Listed drug product patent expiration.

    Dec 21, 2037

    in 11 yr 7 mo

  11. Patent 11771830 expires

    Listed drug product patent expiration.

    Dec 21, 2037

    in 11 yr 7 mo

Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038TodayPatent 11590286 — 2026-12-12Patent 11590286Patent 8206360 — 2027-02-27Patent 8206360Patent 7947017 — 2028-03-12Patent 7947017Patent 8231573 — 2028-11-25Patent 8231573Patent 8226610 — 2029-04-10Patent 8226610Patent 8021344 — 2029-11-02Patent 8021344Patent 10688244 — 2037-12-21Patent 10688244Patent 10842938 — 2037-12-21Patent 10842938Patent 11771830 — 2037-12-21Patent 11771830
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

EPINEPHRINE

Strength

EQ 0.15MG/DELIVERY

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

BX

Application

NDA 201739

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 201739

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Epinephrine family
Orange Book patent file

Listed patents

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11590286Dec 12, 2026in 5 mo
Product
8206360Feb 27, 2027in 8 mo
Product
7947017Mar 12, 2028in 1 yr 8 mo
Product
8231573Nov 25, 2028in 2 yr 5 mo
Product
8226610Apr 10, 2029in 2 yr 9 mo
Product
8021344Nov 02, 2029in 3 yr 4 mo
Product
10688244Dec 21, 2037in 11 yr 7 mo
ProductU-2980
10842938Dec 21, 2037in 11 yr 7 mo
ProductU-2980
11771830Dec 21, 2037in 11 yr 7 mo
ProductU-2980

Auvi-q — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Epinephrine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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