Orange Book drug · Brand (NDA)

Lupron Depot-ped Kit

Leuprolide Acetate

RLDNDA 020263 8 strengths Abbvie Endocrine Inc

Approved

Apr 16, 1993

Strengths

Listed patents

What does the FDA Orange Book show for Lupron Depot-ped Kit?

Lupron Depot-ped Kit contains Leuprolide Acetate and is the new drug FDA Orange Book record for NDA 020263. The application has 8 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application: NDA 020263
Application holder: Abbvie Endocrine Inc
Product presentations: 8
Marketing categories: Prescription and Discontinued
Reference roles: RLD / RS
TE codes: None posted
Listed patents: 2
Exclusivity records: 1

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
002	7.5MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS
003	3.75MG,7.5MG	POWDERINTRAMUSCULAR	Discontinued	None posted	RLD
004	7.5MG,7.5MG	POWDERINTRAMUSCULAR	Discontinued	None posted	RLD
005	11.25MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS
006	15MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS
007	11.25MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS
008	30MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS
009	45MG	POWDERINTRAMUSCULAR	Prescription	None posted	RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Abbvie Endocrine Inc

The Orange Book identifies this organization as the applicant responsible for NDA 020263.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

Status varies by presentation: 6 prescription and 2 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

2 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 05, 2031. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

10 other ANDAs and 12 other NDAs found

8 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 020263 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Intramuscular

Leuprolide Acetate

1 application

Product rows: 8
Active applications: 1
Active with AB row: 0

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-020263

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

8 approved presentations · NDA 020263

RLDRS

Strength: 7.5MG
Dosage form: POWDER
Route: INTRAMUSCULAR
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Apr 16, 1993
33 yr 9 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

LEUPROLIDE ACETATE

Strength

7.5MG

Dosage form

POWDER

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 020263

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

RLDRS

Strength: 45MG
Dosage form: POWDER
Route: INTRAMUSCULAR
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Apr 14, 2023
3 yr 4 mo ago
Exclusivity ends · NS
New strength exclusivity (3 years)
Apr 14, 2026
3 mo ago
Today
Patent 9617303 expires
Listed method-of-use patent (U-3611) expiration.
Mar 22, 2028
in 1 yr 8 mo
Patent 8921326 expires
Listed drug product patent expiration.
Feb 05, 2031
in 4 yr 7 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

LEUPROLIDE ACETATE

Strength

45MG

Dosage form

POWDER

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 020263

Product number

009

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman

NSNew strength exclusivity (3 years)
Apr 14, 2026
3 mo ago

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9617303	Mar 22, 2028	in 1 yr 8 mo	U-3611
8921326	Feb 05, 2031	in 4 yr 7 mo	Product

Active-ingredient family

Brand + generics

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

View full Leuprolide Acetate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.