LUPRON DEPOT-PED KIT Drug Patent Profile

Which patents cover Lupron Depot-ped Kit, and what generic alternatives are available?

Lupron Depot-ped Kit is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. 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-PED KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven 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-ped Kit

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

Summary for LUPRON DEPOT-PED KIT

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	134
DailyMed Link:	LUPRON DEPOT-PED KIT at DailyMed

Recent Clinical Trials for LUPRON DEPOT-PED KIT

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

Sponsor	Phase
NRG Oncology	Phase 2
Prostate Cancer Foundation	Phase 2
Panbela Therapeutics	Phase 2

See all LUPRON DEPOT-PED KIT clinical trials

US Patents and Regulatory Information for LUPRON DEPOT-PED KIT

LUPRON DEPOT-PED KIT is protected by two US patents and one FDA Regulatory Exclusivity.

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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993		DISCN	Yes	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011		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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	9,617,303

Expired US Patents for LUPRON DEPOT-PED KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994	5,480,656
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	5,631,021
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	5,330,767
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	5,631,020

International Patents for LUPRON DEPOT-PED KIT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0586238	Procédé de préparation de microcapsules à libération prolongée (Method of producing sustained-release microcapsules)
China	1055618
Colombia	6180498	UNA COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO FISIOLOGICAMENTE ACTIVO SOLUBLE EN AGUA DISPERSADO UNIFORMEMENTE EN UNA MICROCAPSULA
Ireland	57721	METHOD FOR PRODUCING MICROCAPSULE

LUPRON DEPOT-PED KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUPRON DEPOT-PED KIT

Introduction to LUPRON DEPOT-PED KIT

LUPRON DEPOT-PED is a formulation of leuprolide acetate, specifically designed for the treatment of Central Precocious Puberty (CPP) in children. This medication is administered via intramuscular injection and works by suppressing the hormones that cause premature puberty.

Market Context: Pharmaceutical Industry Overview

The global pharmaceutical market is a vast and growing sector, estimated to be worth USD 1,482.0 billion in 2022 and projected to grow at a CAGR of 6.12% from 2023 to 2030. This growth is driven by factors such as the increasing prevalence of chronic diseases, a rising geriatric population, and significant investments in research and development[3].

Specific Market Segment: Hormonal Therapies

Within the pharmaceutical market, hormonal therapies like LUPRON DEPOT-PED play a crucial role, particularly in treating conditions such as CPP. The branded segment, which includes drugs like LUPRON DEPOT-PED, dominated the market with a revenue share of 67.60% in 2022. This dominance is attributed to the rising prevalence of chronic and rare conditions, along with the continuous development and approval of novel therapeutics[3].

FDA Approvals and Treatment Options

The FDA approval of new strengths for LUPRON DEPOT-PED, including three-month formulations, has expanded treatment options for children with CPP. This approval reduces the number of injections per year from 12 to as few as four, enhancing patient compliance and convenience[4].

Administration and Pharmacokinetics

LUPRON DEPOT-PED is administered via a prefilled dual-chamber syringe, which contains sterile lyophilized microspheres. These microspheres release leuprolide in two phases: an initial diffusion phase and a subsequent bioerosion phase. This mechanism ensures sustained hormone suppression over the intended dosing period, whether it be one, three, or six months[1].

Patient Savings and Support Programs

To make LUPRON DEPOT-PED more accessible, AbbVie offers a Co-pay Savings Card for eligible patients. This program can reduce the co-pay to as little as $10 per month for commercially insured patients, although it is not available for those covered by federal, state, or government-funded healthcare programs[2].

Financial Trajectory

Revenue and Market Share

LUPRON DEPOT-PED, as part of the broader hormonal therapy market, contributes significantly to the revenue of its manufacturer, AbbVie. The branded segment's dominance and the continuous need for treatments like LUPRON DEPOT-PED ensure a stable revenue stream. However, the patent expiry of branded drugs and the entry of generic alternatives can impact long-term revenue projections[3].

Cost and Affordability

The cost of LUPRON DEPOT-PED can be substantial, but savings programs and co-pay assistance can mitigate out-of-pocket expenses for eligible patients. For instance, the maximum monthly benefit under the co-pay assistance program can be up to $300 for monthly injections or $600 for quarterly injections[2].

Market Growth Drivers

• Increasing Prevalence of CPP: Central precocious puberty, though rare, affects one in every 5,000 to 10,000 children, more commonly in girls. This consistent demand ensures a steady market for LUPRON DEPOT-PED[4].
• Advancements in Formulations: The introduction of new strengths and longer-acting formulations enhances patient compliance and reduces the frequency of injections, making the treatment more appealing and convenient[4].
• Healthcare Spending: Increased healthcare spending globally, particularly in regions like North America, supports the growth of the pharmaceutical market, including drugs like LUPRON DEPOT-PED[3].

Challenges and Considerations

Side Effects and Safety

While LUPRON DEPOT-PED is effective, it comes with side effects such as injection-site pain, weight gain, headache, altered mood, and injection-site swelling. These side effects must be carefully managed to ensure patient comfort and adherence to the treatment regimen[4].

Regulatory and Patent Issues

The pharmaceutical industry is heavily regulated, and patent expiries can significantly impact revenue. As patents for branded drugs like LUPRON DEPOT-PED expire, generic alternatives may enter the market, potentially reducing market share and revenue[3].

Key Takeaways

• Market Position: LUPRON DEPOT-PED is a key player in the hormonal therapy segment, particularly for treating CPP.
• Financial Stability: The drug benefits from a stable revenue stream due to its branded status and continuous demand.
• Patient Support: Savings programs and co-pay assistance help make the treatment more affordable for eligible patients.
• Regulatory and Patent Considerations: The industry is subject to regulatory changes and patent expiries, which can impact long-term financial trajectories.

FAQs

Q: What is LUPRON DEPOT-PED used for?

A: LUPRON DEPOT-PED is used to treat Central Precocious Puberty (CPP) in children by suppressing the hormones that cause premature puberty.

Q: How is LUPRON DEPOT-PED administered?

A: It is administered as an intramuscular injection, available in one-month, three-month, and six-month formulations.

Q: What are the common side effects of LUPRON DEPOT-PED?

A: Common side effects include injection-site pain, weight gain, headache, altered mood, and injection-site swelling.

Q: Are there any savings programs available for LUPRON DEPOT-PED?

A: Yes, AbbVie offers a Co-pay Savings Card that can reduce the co-pay to as little as $10 per month for eligible patients.

Q: How does the FDA approval of new strengths impact treatment?

A: The FDA approval of three-month formulations reduces the number of injections per year, enhancing patient compliance and convenience.

Sources

1. Lupronpedpro.com: Dosing and Administration | LUPRON DEPOT-PED® (leuprolide acetate for depot suspension).
2. Luprongyn.com: LUPRON DEPOT® Copay Savings Card.
3. Grandviewresearch.com: Pharmaceutical Market Size, Share & Trends Report, 2030.
4. Prnewswire.com: Abbott Receives FDA Approval for Two Three-Month Strengths of LUPRON DEPOT-PED (leuprolide acetate for depot suspension) for the Treatment of Central Precocious Puberty (CPP).