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Last Updated: December 22, 2024

PROGESTERONE Drug Patent Profile


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When do Progesterone patents expire, and what generic alternatives are available?

Progesterone is a drug marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly. and is included in fifteen NDAs.

The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Progesterone

A generic version of PROGESTERONE was approved as progesterone by FRESENIUS KABI USA on April 25th, 2001.

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Drug patent expirations by year for PROGESTERONE
Drug Prices for PROGESTERONE

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Drug Sales Revenue Trends for PROGESTERONE

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Recent Clinical Trials for PROGESTERONE

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SponsorPhase
Instituto Valenciano de Infertilidad, IVI VALENCIAN/A
Ohio State UniversityPhase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 3

See all PROGESTERONE clinical trials

Pharmacology for PROGESTERONE
Drug ClassProgesterone
Medical Subject Heading (MeSH) Categories for PROGESTERONE

US Patents and Regulatory Information for PROGESTERONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny PROGESTERONE progesterone CAPSULE;ORAL 207724-001 Sep 7, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma PROGESTERONE progesterone INJECTABLE;INJECTION 210965-001 Dec 6, 2018 AO RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-001 Oct 26, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma PROGESTERONE progesterone CAPSULE;ORAL 200900-002 Aug 16, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms PROGESTERONE progesterone CAPSULE;ORAL 202121-002 Feb 29, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PROGESTERONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Progesterone

Market Size and Growth Projections

The progesterone market is poised for significant growth over the coming years. As of 2024, the market size is estimated to be around USD 1.74 billion, with projections indicating it will reach USD 2.67 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 8.92% during this period[1][3][4].

Regional Market Performance

North America

North America is expected to dominate the progesterone market, driven by the increasing adaptability of advanced treatments among the population and the high disease burden in the region. The rise in cases of breast, uterine, and other cancers, along with the growing population of menopausal women, contributes to this dominance[1].

Asia Pacific

The Asia Pacific region is identified as the fastest-growing market for progesterone. This growth is fueled by increasing healthcare awareness, government initiatives to enhance maternal health, and the massive population in countries like China. The CAGR in this region is expected to be higher than in other regions, driven by urbanization and lifestyle changes that increase the prevalence of hormonal diseases[1][4].

United Kingdom and China

In the United Kingdom, the progesterone market is supported by strong healthcare facilities and a focus on women's health, leading to a CAGR of 13.70% from 2024 to 2034. Government schemes and favorable reimbursement programs further boost market growth[4].

In China, the market is expected to grow at a CAGR of 13.20% during the same period, driven by government-led initiatives for maternal health and the expanding healthcare infrastructure[4].

United States

The U.S. market is also experiencing significant growth, with a CAGR of 12.60% from 2024 to 2034. This is attributed to the increasing adoption of bioidentical hormone therapy and the expanding interest in organic alternatives. Strict regulatory rules ensure the safety of these therapies, sustaining consumer confidence[4].

Key Drivers of Market Growth

Increasing Prevalence of Breast Cancer

One of the primary drivers of the progesterone market is the increasing prevalence of breast cancer. According to the International Agency for Research on Cancer (IARC), about 2.2 million new cases of breast cancer were reported worldwide in 2020, and this number is expected to reach 3 million by 2040. This rise in breast cancer cases significantly increases the demand for progesterone, which is used in treating associated symptoms like breast tenderness[1][3].

Technological Advancements

Technological advancements in drug delivery systems and the development of new formulations are also driving market growth. For instance, the launch of new products like Utrozhestan (progesterone) by Besins Healthcare in Russia has contributed to the market's expansion[1].

Patient Awareness and Monitoring

Increasing patient awareness and the routine monitoring of progesterone formulations are additional factors fueling market growth. Patients are becoming more informed about the benefits and uses of progesterone, leading to higher demand for these treatments[1].

Product Segments

Natural vs. Synthetic Progesterone

The progesterone market is segmented into natural and synthetic progesterone. Natural progesterone, derived from sources like soybeans or the Mexican yam Dioscorea Villosa, is expected to witness significant growth. Drugs such as Crinone and Prometrium are major contributors to the revenue in this segment[1].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the progesterone market. Clinical trials, such as the one conducted at Cedars-Sinai Medical Center, showed that progesterone could improve clinical outcomes for certain hospitalized male patients with COVID-19. This increased the demand for progesterone, contributing to market growth during the pandemic[1].

Market Trends

Focus on Women's Health

There is a growing focus on women's health globally, which is driving the demand for progesterone. Government initiatives and progressive policy frameworks, especially in regions like the United Kingdom and China, are supporting this trend[4].

Bioidentical Hormone Therapy

The increasing adoption of bioidentical hormone therapy in regions like the United States is another significant trend. This shift towards organic and natural alternatives is boosting the demand for progesterone[4].

Challenges and Regulatory Environment

Stringent Regulations

Despite the growth drivers, the progesterone market faces challenges such as stringent regulations. These regulatory hurdles can impede market growth by ensuring strict safety standards and potentially slowing down the approval process for new products[3][4].

Carcinogenicity Concerns

There are also concerns regarding the carcinogenic potential of progesterone, particularly in relation to breast cancer. While the clinical relevance of these findings is still under investigation, they could impact consumer confidence and regulatory approvals[2].

Financial Outlook

The financial trajectory of the progesterone market is robust, with significant growth projected over the next decade. Here are some key financial highlights:

  • Market Size in 2024: USD 1.74 billion[1]
  • Projected Market Size in 2029: USD 2.67 billion[1]
  • CAGR from 2024 to 2029: 8.92%[1]
  • Projected Market Size in 2034: USD 4.80 billion[4]
  • CAGR from 2024 to 2034: 12.30%[4]

Key Players

The progesterone market is competitive, with several key players driving innovation and growth. Some of the major companies operating in this market include Cadila Pharmaceuticals, Alkem Labs, Cipla Limited, Lupin Limited, and Glenmark Pharmaceuticals[1].

Conclusion

The progesterone market is poised for substantial growth, driven by increasing demand due to the rising prevalence of breast cancer, technological advancements, and growing patient awareness. While regulatory challenges and carcinogenicity concerns exist, the overall financial outlook is positive, with significant growth projected over the next decade.

Key Takeaways

  • The progesterone market is expected to grow from USD 1.74 billion in 2024 to USD 2.67 billion by 2029.
  • The Asia Pacific region is the fastest-growing market for progesterone.
  • North America holds the largest market share due to high disease burden and advanced treatment adaptability.
  • The increasing prevalence of breast cancer is a key driver of market growth.
  • Natural progesterone is expected to witness lucrative growth due to its widespread use in drug therapies.
  • Regulatory challenges and carcinogenicity concerns are potential impediments to market growth.

FAQs

What is the current size of the progesterone market?

The progesterone market size is estimated to be USD 1.74 billion in 2024[1].

Which region is expected to dominate the progesterone market?

North America is expected to hold the largest share of the progesterone market[1].

What is the fastest-growing region for the progesterone market?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period[1].

What are the key drivers of the progesterone market growth?

The increasing prevalence of breast cancer, technological advancements in drug delivery systems, and growing patient awareness are key drivers of market growth[1][3].

Which segment of progesterone is expected to witness healthy growth?

The natural progesterone segment is expected to witness lucrative growth due to its widespread use in drug therapies[1].

Sources

  1. Mordor Intelligence: Progesterone Market - Growth, Report, Applications & Manufacturers
  2. DrugBank: Progesterone: Uses, Interactions, Mechanism of Action
  3. Technavio: Progesterone Market Growth Analysis - Size and Forecast 2024-2028
  4. Future Market Insights: Progesterone Market Size, Share, Trends & Forecast by 2034

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