ELIGARD KIT Drug Patent Profile

Which patents cover Eligard Kit, and what generic alternatives are available?

Eligard Kit is a drug marketed by Tolmar and is included in four NDAs. There are two patents protecting this drug.

This drug has eleven patent family members in eleven countries.

The generic ingredient in ELIGARD 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 Eligard Kit

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

Summary for ELIGARD KIT

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Clinical Trials:	52
DailyMed Link:	ELIGARD KIT at DailyMed

Recent Clinical Trials for ELIGARD 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 ELIGARD KIT clinical trials

Pharmacology for ELIGARD KIT

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

US Patents and Regulatory Information for ELIGARD KIT

ELIGARD KIT 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
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes				Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes				Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002		RX	Yes	Yes			Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes			Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes			Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002		RX	Yes	Yes				Y

Expired US Patents for ELIGARD KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004

International Patents for ELIGARD KIT

See the table below for patents covering ELIGARD KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4686653
Japan	H05305135
Denmark	1586309
Australia	666676
Denmark	2158900
Mexico	PA03002552	FORMULACIONES DE ADMINISTRACION POLIMERICA DE LEUPROLIDA CON EFICACIA MEJORADA. (POLYMERIC DELIVERY FORMULATIONS OF LEUPROLIDE WITH IMPROVED EFFICACY.)

Supplementary Protection Certificates for ELIGARD KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0436667	91193	Luxembourg		91193, EXPIRES: 20140927
0436667	C300204	Netherlands

ELIGARD KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of ELIGARD (Leuprolide Acetate)

Introduction to ELIGARD

ELIGARD, developed and manufactured by TOLMAR Inc., is a gonadotropin-releasing hormone (GnRH) agonist used for the palliative treatment of advanced prostate cancer. It works by reducing the production of testosterone, which is known to stimulate the growth of prostate cancer cells[1][2][5].

Market Size and Growth

The leuprolide acetate market, which includes ELIGARD, has shown significant growth and is expected to continue this trend. As of 2022, the global leuprolide acetate market size was valued at over USD 2 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6% from 2023 to 2032, reaching an estimated value of USD 3.5 billion by 2032[4].

Key Market Drivers

Increasing Prevalence of Cancer

The rising incidence of cancer, particularly prostate cancer, is a major driver for the leuprolide acetate market. According to the World Health Organization (WHO), cancer caused over 10 million deaths in 2020, with prostate cancer being a significant contributor to this statistic[4].

Advantages of Pre-filled Syringes

The segment of pre-filled syringes, which includes ELIGARD, was worth over USD 910 million in 2022. The convenience, reduced patient risk, and lower time and monetary investment associated with pre-filled syringes are driving their adoption[4].

Customizable Dosing and Extended Control

ELIGARD offers customizable dosing options and extended control through its unique in situ polymeric gel technology, which enhances its efficacy and patient compliance. This technology allows for sustained efficacy throughout the dosing period, making it a preferred choice for healthcare providers[2].

Market Segments

Product Form

The leuprolide acetate market is segmented into lyophilized powder, vials, and pre-filled syringes. The pre-filled syringes segment is particularly strong due to its convenience and reduced risk of errors[4].

Application

The cancer segment, which includes advanced prostate cancer, held more than 25% of the revenue share in 2022. Other applications include central precocious puberty, endometriosis, and hormone therapy[4].

Route of Administration

The intradermal route of administration is gaining traction due to its long absorption duration, making it suitable for hormone therapy and other treatments. This segment is projected to exhibit a CAGR of over 5.5% from 2023 to 2032[4].

Distribution Channel

The market is classified into retail pharmacy, hospital pharmacy, and online pharmacy. The online pharmacy segment is expected to grow significantly, driven by the increasing patient inclination towards online shopping, especially post-COVID-19[4].

Regional Market Dynamics

North America

North America held more than 39% of the industry share in 2022, driven by the rising incidence of cancer and a favorable regulatory landscape. The U.S. FDA's approval processes support the growth of leuprolide acetate products in this region[4].

Challenges and Pitfalls

Drug Price Control Policies

Strict drug price control policies are a significant challenge for the leuprolide acetate market. These policies can lower prescription prices but also reduce Research and Development (R&D) funding, impacting business growth[4].

COVID-19 Impact

The COVID-19 pandemic affected the pharmaceutical industry, including the leuprolide acetate market, through changes in demand, supply shortages, and modifications to R&D procedures. However, the pandemic also accelerated the adoption of online pharmacies and other digital health solutions[4].

Supply and Manufacturing

TOLMAR Pharmaceuticals has ensured a consistent supply of ELIGARD, even during periods of reported shortages of other leuprolide acetate products. The company has increased production in its state-of-the-art cGMP facilities to meet demand and prevent any gaps in treatment for patients with advanced prostate cancer[5].

Financial Performance and Projections

Given the market size and growth projections, the financial trajectory for ELIGARD and similar leuprolide acetate products looks promising. Here are some key financial highlights:

• Market Size: The global leuprolide acetate market was valued at over USD 2 billion in 2022.
• Growth Rate: Expected to grow at a CAGR of 6% from 2023 to 2032.
• Projected Value: Estimated to reach USD 3.5 billion by 2032[4].

Competitive Landscape

The leuprolide acetate market is competitive, with several key players including TOLMAR Pharmaceuticals, Cipla Limited, and Eugia Pharma Specialty Limited. These companies are engaged in rigorous R&D programs and strategic collaborations to expand their product portfolios and customer base[4].

Key Takeaways

• Growing Market: The leuprolide acetate market, including ELIGARD, is expected to grow significantly due to the increasing prevalence of cancer.
• Customizable and Efficient: ELIGARD offers customizable dosing options and extended control through its unique technology.
• Regional Strength: North America is a key region for the market, driven by favorable regulatory conditions and high cancer incidence.
• Challenges: The market faces challenges from drug price control policies and the impact of the COVID-19 pandemic.
• Consistent Supply: TOLMAR Pharmaceuticals has ensured a consistent supply of ELIGARD to meet patient needs.

FAQs

Q: What is ELIGARD used for? A: ELIGARD is used for the palliative treatment of advanced prostate cancer. It works by reducing the production of testosterone, which stimulates the growth of prostate cancer cells[1][2][5].

Q: How does ELIGARD work? A: ELIGARD is a gonadotropin-releasing hormone (GnRH) agonist that reduces testosterone production in the body, thereby slowing the growth of prostate cancer cells[1][2][5].

Q: What are the key market drivers for ELIGARD? A: The increasing prevalence of cancer, particularly prostate cancer, and the advantages of pre-filled syringes are major drivers for the leuprolide acetate market[4].

Q: What are the potential side effects of ELIGARD? A: ELIGARD may cause increased risk of heart attack, stroke, elevated blood sugar, and an initial increase in testosterone levels, among other side effects. Patients should be monitored by their doctors for these conditions[5].

Q: How has the COVID-19 pandemic impacted the leuprolide acetate market? A: The pandemic has affected demand, supply chains, and R&D processes but has also accelerated the adoption of online pharmacies and digital health solutions[4].

Sources

1. TOLMAR Pharmaceuticals Established To Market ELIGARD For Advanced Prostate Cancer - PR Newswire.
2. ELIGARD® (Leuprolide Acetate) | for Advanced Prostate Cancer - ELIGARD HCP.
3. Update - Redeye - Redeye.
4. Leuprolide Acetate Market Share | Forecasts Report, 2023-2032 - Global Market Insights.
5. Tolmar Affirms Full Supply of ELIGARD® (Leuprolide Acetate) for the Palliative Management of Advanced Prostate Cancer - PR Newswire.