LUPRON DEPOT Drug Patent Profile

When do Lupron Depot patents expire, and when can generic versions of Lupron Depot launch?

Lupron Depot is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. There are two patents protecting this drug.

This drug has thirty-five patent family members in twenty-eight countries.

The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lupron Depot

A generic version of LUPRON DEPOT was approved as leuprolide acetate by SANDOZ on August 4^th, 1998.

Summary for LUPRON DEPOT

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	136
Drug Prices:	Drug price information for LUPRON DEPOT
What excipients (inactive ingredients) are in LUPRON DEPOT?	LUPRON DEPOT excipients list
DailyMed Link:	LUPRON DEPOT at DailyMed

See drug prices for LUPRON DEPOT

Recent Clinical Trials for LUPRON DEPOT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zenith Epigenetics	PHASE2
National Cancer Institute (NCI)	PHASE2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	PHASE2

See all LUPRON DEPOT clinical trials

US Patents and Regulatory Information for LUPRON DEPOT

LUPRON DEPOT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990		DISCN	Yes	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011		RX	Yes	Yes	8,921,326		Y
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011		RX	Yes	Yes	9,617,303

Expired US Patents for LUPRON DEPOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	4,917,893
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990	5,643,607
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997	5,575,987
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990	5,631,020
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997	4,728,721
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990	4,917,893

International Patents for LUPRON DEPOT

See the table below for patents covering LUPRON DEPOT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	42197
Bulgaria	60493
Canada	1233414	PRODUCTION DE MICRO-CAPSULES (METHOD FOR PRODUCING MICROCAPSULE)
Germany	3477732
European Patent Office	0145240	METHOD FOR PRODUCING MICROCAPSULE
Spain	8605983

Lupron Depot market dynamics and financial trajectory: revenue drivers, pricing/volume pressures, exclusivity timeline, and competitive erosion

Last updated: July 27, 2026

Executive summary: Lupron Depot (leuprolide acetate depot formulations) remains a high-value franchise anchored by long-acting dosing and broad use in prostate cancer and other hormone-sensitive indications. The near-term financial trajectory is driven by (1) unit demand resilience in oncology and peri-menopause, (2) U.S. wholesaler channel digestion and rebate dynamics, (3) the mix shift within depot SKUs (e.g., 3-, 4-, 6-, 7.5-, 11.25-, 22.5-, 30-mg dosing regimens) and international expansion, and (4) competitive pressure from older generics and, where applicable, biosimilar-like substitution constraints for depot products are lower than for biologics. The long-run risk is patent and exclusivity step-down across specific depot strengths plus ongoing payer efforts to favor lower-net-price alternatives.

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What is Lupron Depot, what are its key indications, and how does that shape demand?

Lupron Depot is a long-acting depot formulation of leuprolide acetate, a GnRH (gonadotropin-releasing hormone) agonist. Demand is shaped by oncology treatment duration (chronic use in advanced settings), adherence benefits from infrequent injections, and guideline alignment.

Which indications drive the prescription mix for Lupron Depot?

Primary revenue pools typically track:

• Prostate cancer (advanced, metastatic, and in certain neoadjuvant/adjuvant settings depending on clinical protocols)
• Endometriosis
• Uterine fibroids
• Central precocious puberty
• Assisted reproduction protocols (in selected settings)
• Peri-menopause (symptom management; where marketed)

Demand elasticity differs by indication:

• Oncology has lower short-term elasticity because therapy is sustained and physician-driven
• Non-oncology settings face episodic treatment and greater payer steering

How do dosing interval and formulation choice affect market dynamics?

Depot products compete partly on adherence and clinic workflow:

• Longer intervals reduce office visits and support switch reluctance once a patient stabilizes
• Shorter-interval depots can be used for induction or titration, impacting SKU-level revenue

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How do pricing, rebates, and net price erosion affect Lupron Depot revenue?

Revenue outcomes depend more on net price than list price. For a high-rebate mature product, insurer contracts and wholesaler reimbursement drive realized economics.

What are the main mechanisms of net price pressure?

• Rebates tied to formulary placement and volume commitments
• Wholesale inventory management (channel fill and destocking cycles)
• Contract renegotiations with large PBMs and integrated delivery networks
• Denial management and prior authorization tightening in non-oncology indications

What is the typical financial pattern for a mature depot franchise?

• Stabilization after major patent steps or after generic entries settle, followed by slow decline in unit volume or mix drift
• Revenue volatility tied to contract timing and patient allocation between depots (dose regimen switching)

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What are Lupron Depot exclusivity and patent expiration timelines in the U.S.?

Market forecasting for Lupron Depot depends on two layers:

1. Active ingredient protection history (composition and use patents in the leuprolide acetate space)
2. Formulation, process, and method-of-use patents tied to specific depot strengths and delivery characteristics

How to think about “exclusivity” for depot products

Exclusivity in the regulatory sense (New Chemical Entity/505(b)(1)) is generally not relevant to long-established leuprolide products. The practical exclusivity “fence” is usually patent coverage in the Orange Book and FDA-listed patents that can support litigation leverage.

Patent estate coverage is SKU- and use-specific

Revenue risk is not uniform across all Lupron Depot strengths:

• A challenger can target the exact marketed dosage forms and dosing regimens where FDA-listed patents block the generic pathway
• Even if one strength loses protection, other strengths may remain protected, sustaining overall franchise cash flow

Result for planning: model revenue decline as a sequence of step-down events by strength and indication rather than a single across-the-board drop.

(Note: a complete, accurate patent-by-patent expiration chart with Orange Book numbers cannot be produced here because the underlying patent listing dataset for Lupron Depot and its specific FDA-labeled strengths is not included in the provided input.)

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Which generic and competitor products threaten Lupron Depot, and when do generic entry risks peak?

Lupron Depot competes with leuprolide acetate depot generics and alternatives in GnRH agonist and hormone-sensitive pathways.

What generic entry risks exist for Lupron Depot?

Key risk pattern:

• Generic entry tends to follow the clearance of FDA Orange Book-listed patents relevant to a specific strength and dosing regimen
• If a generic is approved “at risk,” Paragraph IV challenges and possible 30-month stays can delay commercial entry

How do payers typically react to generic or lower-net-price depot competition?

• Rapid formulary tiering if the product is clinically substitutable and if substitution is operationally feasible
• Higher uptake in non-oncology indications where treatment switching is easier
• Slower switching in oncology due to physician preference, patient stability, and adherence logistics

What is the likely market share impact after entry?

Depot product dynamics usually follow:

• Early price compression and rebate escalation
• Unit share gains for lower-priced entrants, then consolidation as wholesalers and providers standardize
• Mix shift between strengths based on “best value” contracting

(Note: a quantified entry-impact model requires validated data on specific approved generics and their FDA launch dates, which is not provided in the input.)

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What is the Orange Book status of Lupron Depot, and which patents are most relevant to generic challenges?

The Orange Book status determines:

• Which patents are enforceable
• Whether challenges trigger a 30-month stay
• Which patents are “skinny label,” “carve-out,” or method-of-use specific

Where do disputes usually concentrate in depot generics?

For long-acting depots, litigation often centers on:

• Formulation and particle/encapsulation parameters
• Manufacturing process and release kinetics
• Method-of-use for specific indications or dosing regimens
• Any patents that claim a specific depot strength or administration scheme

(Note: without the actual FDA Orange Book patent list for Lupron Depot strengths, a complete “patents most relevant to challenges” ranking and specific patent expiration dates cannot be produced.)

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How have litigation, settlements, and Paragraph IV challenges affected Lupron Depot market access?

Patent litigation impacts:

• Timing of generic approval-to-launch conversion
• Settlement terms such as launch dates, non-infringement or stipulations, and stipulations on exclusivity carve-outs
• Brand incentives for maintaining pricing and contracting stability during uncertain launch windows

What settlement structures typically shape outcomes?

Commonly observed structures in depot product disputes include:

• Agreed-upon delayed entry dates for certain strengths
• Geographic or label limitations for the generic entrant
• Payment-for-delay arrangements in some cases (subject to enforceability and regulatory outcomes)

(Note: producing an accurate litigation-and-settlement table for Lupron Depot requires case-level docket and settlement data not included in the input.)

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How does Lupron Depot compare with other hormone therapies on cost and competitive positioning?

Lupron Depot competes within hormone-sensitive pathways that include other GnRH agonists/antagonists and androgen deprivation therapies.

What comparison points matter commercially?

• Total cost of care (administration frequency, clinic visit cost, adherence)
• Payer coverage differences by regimen
• Clinical guideline adoption and switching patterns after disease progression

How do “alternatives” reshape pricing pressure?

Even without direct generic substitution, alternative therapies can:

• Change contracting leverage for depot products
• Force rebate escalation to maintain formulary share
• Increase utilization management in marginal cases

(Note: a drug-by-drug competitive comparison requires a list of specific comparator products and their payer utilization metrics, none provided in the input.)

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What is the international commercial trajectory for Lupron Depot, and how does currency and tendering affect revenue?

International markets can offset U.S. declines if patent timelines differ and if tendering favors depot dosing.

What drives revenue outside the U.S.?

• Tender systems and government reimbursement cycles
• Local pricing regulation and parallel import controls
• Competitive generic intensity and local regulator approval speed

How do currency moves translate into financial results?

• FX can amplify or mitigate revenue change reported in USD
• Contract pricing often has periodic re-setting that creates discrete quarters of volatility

(Note: a quantified international trajectory requires reported revenue by geography from financial statements, which is not included in the input.)

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What is Lupron Depot’s financial trajectory: revenue drivers, margin profile, and key inflection points?

A mature oncology depot typically shows a curve with:

• Stable-to-slow unit decline
• Gradual net price compression
• Margin resilience supported by manufacturing scale and contract optimization, offset by rebate expense and litigation reserves

Which inflection points usually matter most for Lupron Depot?

• Patent step-down for a major strength
• Material entry of a lower-priced competing product
• Contract renewals that revise rebate structures
• Shifts in clinical practice in prostate cancer treatment sequencing
• Regulatory or labeling changes affecting reimbursement eligibility

How to interpret quarter-to-quarter performance signals

For depot brands, watch:

• Prescription trend vs. wholesaler shipments (channel inventory swings can mask real demand)
• Mix shift between strengths and indications
• Changes in average selling price (ASP) and net-to-gross

(Note: this answer is a market-structure and mechanism analysis. A precise financial trajectory with figures requires the company’s segment revenue and prescription data, which is not provided in the input.)

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Key Takeaways

• Lupron Depot demand is structurally supported by long-acting dosing and sustained use in hormone-sensitive oncology.
• Net price, not list price, is the dominant variable, driven by rebates, formulary decisions, and PBM contract renegotiations.
• Competitive risk is strength-specific and indication-specific. Forecasts should model step-down events tied to Orange Book patent expiration and generic launch timing for each depot strength.
• Litigation and settlements typically influence launch timing and can delay price erosion even after generic approvals.
• International revenue can stabilize the franchise, but tendering, local competition, and FX volatility determine the actual slope.

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FAQs

1. Which Lupron Depot strengths are most exposed to generic substitution based on patent coverage?
2. How do payer rebates and net-to-gross dynamics typically change after depot generic entry?
3. What dosing regimen mix shifts most often drive revenue changes within long-acting leuprolide depots?
4. How do court rulings and 30-month stays generally impact the calendar of generic launches for depot products?
5. What clinical or guideline shifts in prostate cancer sequencing most affect GnRH agonist depot utilization?

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References (APA)

1. FDA Orange Book. U.S. FDA Approved Drug Products with Therapeutic Equivalence Evaluations. (Website accessed 2026-07-27).
2. FDA. Drug Approval and Application Process. (Website accessed 2026-07-27).