Assyro AI

Orange Book product · Brand (NDA)

LUPRON DEPOT-PED KIT

LEUPROLIDE ACETATE

Brand (NDA)NDA 020263RX ABBVIE ENDOCRINE INC

At a glance

Apr 14, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 14, 2023

    3 yr 3 mo ago

  2. Exclusivity ends · NS

    New strength exclusivity (3 years)

    Apr 14, 2026

    2 mo ago

  3. Today

  4. Patent 9617303 expires

    Listed method-of-use patent (U-3611) expiration.

    Mar 22, 2028

    in 1 yr 9 mo

  5. Patent 8921326 expires

    Listed drug product patent expiration.

    Feb 05, 2031

    in 4 yr 8 mo

Pharmaceutical detail

Active ingredient

LEUPROLIDE ACETATE

Strength

45MG

Dosage form

POWDER

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 020263

Product number

009

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

  • NSNew strength exclusivity (3 years)

    Apr 14, 2026

    2 mo ago

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9617303Mar 22, 2028in 1 yr 9 mo
U-3611
8921326Feb 05, 2031in 4 yr 8 mo
Product
Agent CTA Background

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