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Last Updated: December 23, 2024

eligard kit Drug Patent Profile


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Which patents cover Eligard Kit, and when can generic versions of Eligard Kit launch?

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 4th, 1998.

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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
Drug patent expirations by year for eligard kit
Recent Clinical Trials for eligard kit

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

SponsorPhase
NRG OncologyPhase 2
Panbela TherapeuticsPhase 2
Prostate Cancer FoundationPhase 2

See all eligard kit clinical trials

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 021488-001 Feb 13, 2003 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 ⤷  Subscribe ⤷  Subscribe
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for eligard kit

See the table below for patents covering eligard kit around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 4135830 SYSTÈMES ET PROCÉDÉS DE COMBINAISON D'ENSEMBLES VALVE DE SERINGUE (SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES) ⤷  Subscribe
Japan 3451259 ⤷  Subscribe
Australia 6614294 ⤷  Subscribe
New Zealand 286487 METHOD OF FORMING AN IN SITU IMPLANT USING A THERMOPLASTIC POLYMER ⤷  Subscribe
Japan 4686653 ⤷  Subscribe
Canada 1340694 IMPLANTS BIODEGRADABLES FORMES IN SITU ET METHODES POUR LES OBTENIR (BIODEGRADABLE IN-SITU FORMING IMPLANTS AND METHODS OF PRODUCING THE SAME) ⤷  Subscribe
European Patent Office 1126822 COMPOSITIONS DE DISTRIBUTION LIQUIDES A LIBERATION CONTROLEE AVEC FAIBLE DECHARGE INITIALE DE MEDICAMENT (CONTROLLED RELEASE LIQUID DELIVERY COMPOSITIONS WITH LOW INITIAL DRUG BURST) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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.

More… ↓

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