Orange Book product · Brand (NDA)

ELIGARD KIT

LEUPROLIDE ACETATE

Brand (NDA)NDA 021731RX TOLMAR

Dec 14, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 14, 2004
21 yr 10 mo ago
Today
Patent 11771841 expires
Listed drug substance patent expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 11931559 expires
Listed drug substance patent expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12397120 expires
Listed method-of-use patent (U-4001) expiration.
Dec 22, 2041
in 15 yr 9 mo

Active ingredient

LEUPROLIDE ACETATE

Strength

45MG

Dosage form

POWDER

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 021731

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11771841	Dec 22, 2041	in 15 yr 9 mo	SubstanceProduct
11931559	Dec 22, 2041	in 15 yr 9 mo	Substance
12397120	Dec 22, 2041	in 15 yr 9 mo	U-4001