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Last Updated: April 2, 2025

LUPRON Drug Patent Profile


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

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Lupron

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

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Drug patent expirations by year for LUPRON
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Recent Clinical Trials for LUPRON

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SponsorPhase
NRG OncologyPhase 2
Prostate Cancer FoundationPhase 2
Panbela TherapeuticsPhase 2

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US Patents and Regulatory Information for LUPRON

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie Endocrine Inc LUPRON leuprolide acetate SOLUTION;SUBCUTANEOUS 019010-001 Apr 9, 1985 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-009 Apr 14, 2023 RX Yes Yes 8,921,326 ⤷  Try for Free Y ⤷  Try for Free
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Leuprolide (LUPRON)

Introduction to Leuprolide (LUPRON)

Leuprolide, commonly known by the brand name LUPRON, is a synthetic analog of gonadotropin-releasing hormone (GnRH) that acts as a potent luteinizing hormone-releasing hormone (LHRH) agonist. It is widely used in the treatment of various hormone-dependent conditions, including prostate cancer, endometriosis, uterine fibroids, and precocious puberty.

Market Size and Growth Projections

The global leuprolide market has been experiencing significant growth and is projected to continue this trend in the coming years.

  • The market size was estimated at approximately $2.60 billion in 2023 and is expected to grow to $4.78 billion by 2034, with a compound annual growth rate (CAGR) of 5.7% from 2024 to 2034[1].
  • Another projection indicates that the market was valued at around $2.57 billion in 2023 and is projected to reach $3.58 billion by 2030, growing at a CAGR of 4.86% during this period[3].

Key Drivers of Market Growth

Several factors are driving the growth of the leuprolide market:

Increasing Prevalence of Hormone-Sensitive Conditions

  • The rising cases of prostate and breast cancer are significant drivers. For instance, in India, the cases of prostate cancer were 43,691 in 2022, and breast cancer cases were 221,757, with these numbers expected to rise significantly in the future[1].
  • Endometriosis, affecting one or more in ten women between the ages of 15 and 44 in the United States, also contributes to the demand for leuprolide[4].

Innovations in Formulations

  • The introduction of extended-release formulations has improved patient compliance and treatment outcomes. These innovations provide sustained hormone suppression with fewer injections, enhancing the overall efficacy of the treatment[3].

Partnerships and Research Collaborations

  • Pharmaceutical companies are forming partnerships with research institutions to develop new applications for leuprolide, potentially expanding its use beyond traditional indications and opening new revenue streams[3].

Personalized Medicine

  • The trend towards personalized medicine is gaining traction, with treatments being tailored based on individual patient profiles. This approach can lead to better outcomes and improved patient satisfaction[3].

Regional Market Dynamics

Asia Pacific

  • The Asia Pacific region is expected to grow at the fastest rate during the forecast period. Countries like China, India, Japan, and South Korea are major contributors to this growth due to their large-scale pharmaceutical industries and increasing healthcare investments[1].

Global Market Reach

  • The leuprolide market is global, with significant demand in regions like North America and Europe, driven by the high prevalence of hormone-sensitive conditions and advanced healthcare infrastructure.

Financial Performance of Key Players

AbbVie

  • While AbbVie's financial reports do not specifically highlight leuprolide, the company's overall performance in the pharmaceutical sector is relevant. AbbVie reported full-year net revenues of $54.318 billion in 2023, with a decrease of 6.4% on a reported basis. The company is strengthening its oncology and neuroscience portfolios through acquisitions, which could indirectly impact the market dynamics for leuprolide[2].

Astellas Pharma

  • Astellas Pharma, another major player, reported a revenue decrease of 2% YoY in Q1 of FY2023, mainly due to the impact of generics. However, their global sales of key products like XTANDI showed steady growth, indicating a robust performance in the oncology segment, which could be relevant to the leuprolide market[5].

Competitive Analysis

The leuprolide market is competitive, with several pharmaceutical companies involved in its production and distribution.

  • Market Leaders: Companies like AbbVie and Astellas Pharma are key players in the market, with significant investments in research and development to enhance their product portfolios.
  • Innovations and Partnerships: The competitive landscape is characterized by innovations in formulations and partnerships with research institutions to expand the applications of leuprolide[3].

Veterinary Use

In addition to human health, leuprolide is also used in veterinary treatments, which adds another layer of demand to the market.

  • The use of leuprolide in veterinary medicine for conditions such as prostate issues in dogs contributes to the overall growth of the market[4].

Regulatory Environment

The regulatory environment plays a crucial role in the growth and stability of the leuprolide market.

  • FDA Approvals: Leuprolide has been authorized by the FDA for various indications, including the treatment of endometriosis and prostate cancer. These approvals are critical for market growth and patient access[1].

Future Outlook

The future outlook for the leuprolide market is promising, driven by several factors:

  • Increasing Demand: The rising prevalence of hormone-sensitive conditions and the need for effective treatments will continue to drive demand.
  • Innovations: Ongoing innovations in formulations and treatment approaches will enhance patient outcomes and compliance.
  • Global Expansion: The market is expected to expand globally, with significant growth anticipated in regions like the Asia Pacific.
"The global Leuprolide market represents a significant opportunity for investment due to its steady growth driven by increasing demand for effective treatments for hormone-sensitive conditions and ongoing innovations within the pharmaceutical industry."[3]

Key Takeaways

  • The global leuprolide market is projected to grow significantly, driven by increasing demand for treatments of hormone-sensitive conditions.
  • Innovations in formulations and partnerships with research institutions are key drivers of market growth.
  • The Asia Pacific region is expected to grow at the fastest rate during the forecast period.
  • The market is competitive, with major pharmaceutical companies investing in research and development.
  • Veterinary use of leuprolide adds to the overall market demand.

FAQs

Q: What is leuprolide used for?

  • Leuprolide is used for treating various hormone-dependent conditions, including prostate cancer, endometriosis, uterine fibroids, and precocious puberty.

Q: What is the projected market size of leuprolide by 2034?

  • The global leuprolide market is projected to grow to $4.78 billion by 2034[1].

Q: Which region is expected to grow the fastest in the leuprolide market?

  • The Asia Pacific region is expected to grow at the fastest rate during the forecast period[1].

Q: What are the key drivers of the leuprolide market growth?

  • Key drivers include the increasing prevalence of hormone-sensitive conditions, innovations in formulations, and partnerships with research institutions[1][3].

Q: Is leuprolide used in veterinary medicine?

  • Yes, leuprolide is also used in veterinary treatments, contributing to the overall market demand[4].

Sources

  1. Towards Healthcare: Leuprorelin Drugs Market Companies, Trends & Data Insight
  2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results
  3. Market Research Intellect: Leuprolide Market Size And Projection
  4. Market Research Future: Leuprolide Acetate Market Projected To Grow Radiantly By 2030
  5. Astellas Pharma: Financial Results for the Q1 of FY2023 - Astellas Pharma Inc.

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