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Last Updated: April 1, 2025

Leuprolide acetate; norethindrone acetate - Generic Drug Details


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What are the generic drug sources for leuprolide acetate; norethindrone acetate and what is the scope of freedom to operate?

Leuprolide acetate; norethindrone acetate is the generic ingredient in one branded drug marketed by Abbvie Endocrine and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for leuprolide acetate; norethindrone acetate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:leuprolide acetate; norethindrone acetate at DailyMed
Recent Clinical Trials for leuprolide acetate; norethindrone acetate

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 3

See all leuprolide acetate; norethindrone acetate clinical trials

US Patents and Regulatory Information for leuprolide acetate; norethindrone acetate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-002 Dec 14, 2012 DISCN Yes No ⤷  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 2 of 2 entries

Expired US Patents for leuprolide acetate; norethindrone acetate

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 ⤷  Try for Free ⤷  Try for Free
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-002 Dec 14, 2012 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 2 of 2 entries

Leuprolide Acetate and Norethindrone Acetate: Market Dynamics and Financial Trajectory

Introduction

Leuprolide acetate and norethindrone acetate are crucial medications in the treatment of various hormonal disorders. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand for these drugs.

Market Size and Growth Projections

The global leuprolide acetate market is anticipated to experience significant growth over the coming years. As of 2024, the market is valued at approximately USD 3.82 billion and is expected to reach USD 5.81 billion by 2031, with a compound annual growth rate (CAGR) of 6.2%[1].

Another projection indicates that the market could reach USD 3.58 billion by 2030, growing at a CAGR of 4.86% from 2024 to 2030[3].

Key Drivers of Market Growth

Increasing Prevalence of Prostate Cancer and Endometriosis

The rising incidence of prostate cancer and endometriosis globally is a major driver of the leuprolide acetate market. Prostate cancer is one of the most common cancers affecting men worldwide, and leuprolide acetate is a widely used treatment for this condition[1][3][4].

Advancements in Drug Delivery Formulations

The development of advanced drug delivery formulations, such as injections and implants, has enhanced the efficacy and reduced the treatment duration of leuprolide acetate. This has further boosted market growth[1].

Improvements in Healthcare Infrastructure

Enhancements in healthcare infrastructure and accessibility to medical facilities worldwide have improved early diagnosis and treatment for various medical conditions. This has increased the demand for leuprolide acetate[3].

Market Segmentation

Product Type

The intramuscular segment is expected to grow at the fastest rate due to the higher efficacy and longer duration of action of intramuscular injections compared to subcutaneous injections[3].

Application

The prostate cancer segment is the largest and is expected to continue growing due to the increasing prevalence of prostate cancer. Other significant segments include endometriosis, uterine fibroids, and central precocious puberty[3].

Route of Administration

Injections are the largest segment and are expected to continue growing due to their high efficacy compared to other routes of administration[3].

Regional Market Analysis

North America

North America currently dominates the global leuprolide acetate market, with an estimated market share of 40.3% in 2024. The region's strong healthcare infrastructure, presence of key market players, and robust distribution channels contribute to its leadership position[1].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing market for leuprolide acetate, driven by the growing medical needs of the expanding patient population in countries like China and India. The region's pharmaceutical industry is expanding due to lower manufacturing and labor costs, and the availability of cost-effective generic versions[1].

Impact of Norethindrone Acetate

Combination Therapy

The combination of norethindrone acetate (NETA) and leuprolide acetate (LA) has been shown to enhance ovarian suppression and reduce ovarian cyst formation. This combination is particularly effective in patients undergoing ovarian stimulation followed by follicle aspiration and in-vitro fertilization (IVF)[2][5].

Clinical Outcomes

Studies have demonstrated that the addition of NETA to LA reduces the incidence of ovarian cysts without affecting clinical pregnancy and delivery rates. This combination significantly decreases the overall cost per cycle[2][5].

Challenges and Pitfalls

Price Erosion and Generic Versions

The advent of generic versions of leuprolide acetate once leading brand drugs lose their patents can lead to price erosion, hampering revenue growth for market leaders[1].

Regulatory Requirements

Stringent regulatory requirements for drug approval can slow down the entry of new players into the market. However, market players can leverage licensing deals to manufacture and sell generic versions in emerging markets[1].

Drug Price Control Policies

Strict drug price-control policies can adversely impact the market by standardizing medication costs, which can reduce R&D funding and programs[4].

Distribution Channels

Online Pharmacies

The online pharmacy segment is expected to grow significantly, driven by the increasing patient inclination toward online shopping, particularly after the COVID-19 outbreak. This segment's growth is attributed to its wide reachability and inclusion of cutting-edge products[4].

Financial Impact of COVID-19

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

Key Players and Strategic Moves

Major pharmaceutical companies are undertaking rigorous R&D programs and strategic collaborations to expand their customer base and product portfolio. For instance, companies like Cipla Limited and Eugia Pharma Specialty Limited have introduced U.S. FDA-approved leuprolide acetate products, broadening their complex product range[4].

Conclusion

The leuprolide acetate market is poised for significant growth driven by increasing prevalence of prostate cancer and endometriosis, advancements in drug delivery formulations, and improvements in healthcare infrastructure. The combination of norethindrone acetate with leuprolide acetate enhances clinical outcomes and reduces costs. However, the market faces challenges such as price erosion from generic versions and stringent regulatory requirements.

Key Takeaways

  • The global leuprolide acetate market is expected to grow significantly, reaching USD 5.81 billion by 2031.
  • Increasing prevalence of prostate cancer and endometriosis are major drivers of market growth.
  • Advanced drug delivery formulations and improvements in healthcare infrastructure are boosting demand.
  • North America dominates the market, but Asia Pacific is the fastest-growing region.
  • Combination therapy with norethindrone acetate enhances ovarian suppression and reduces costs.
  • The market faces challenges from price erosion and stringent regulatory requirements.

FAQs

What is the current market size of leuprolide acetate?

The global leuprolide acetate market is valued at approximately USD 3.82 billion in 2024[1].

What is the expected CAGR of the leuprolide acetate market from 2024 to 2031?

The market is expected to grow at a CAGR of 6.2% from 2024 to 2031[1].

What are the primary applications of leuprolide acetate?

The primary applications include treating prostate cancer, endometriosis, uterine fibroids, and central precocious puberty[3].

How does the combination of norethindrone acetate and leuprolide acetate impact clinical outcomes?

The combination enhances ovarian suppression, reduces ovarian cyst formation, and significantly decreases the overall cost per cycle without affecting clinical pregnancy and delivery rates[2][5].

Which region is expected to be the fastest-growing market for leuprolide acetate?

The Asia Pacific region is expected to be the fastest-growing market, driven by the growing medical needs in countries like China and India[1].

Sources

  1. Coherent Market Insights: Leuprolide Acetate Market - Report & Production Statistics
  2. PubMed: A combination of norethindrone acetate and leuprolide ...
  3. Maximize Market Research: Leuprolide Acetate Market: An In-Depth Market Analysis & Forecast
  4. Global Market Insights: Leuprolide Acetate Market Share | Forecasts Report, 2023-2032
  5. Watermark: A combination of norethindrone acetate and leuprolide acetate ...

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