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Last Updated: April 13, 2025

PROMETRIUM Drug Patent Profile


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

Prometrium is a drug marketed by Virtus and is included in one NDA.

The generic ingredient in PROMETRIUM 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 Prometrium

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

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Summary for PROMETRIUM
Drug patent expirations by year for PROMETRIUM
Drug Prices for PROMETRIUM

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Recent Clinical Trials for PROMETRIUM

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SponsorPhase
Cystic Fibrosis FoundationPhase 4
Johns Hopkins UniversityPhase 4
Wake Forest University Health SciencesPhase 2

See all PROMETRIUM clinical trials

Pharmacology for PROMETRIUM
Drug ClassProgesterone

US Patents and Regulatory Information for PROMETRIUM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Virtus PROMETRIUM progesterone CAPSULE;ORAL 019781-001 May 14, 1998 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Virtus PROMETRIUM progesterone CAPSULE;ORAL 019781-002 Oct 15, 1999 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Virtus PROMETRIUM progesterone CAPSULE;ORAL 019781-003 Oct 15, 1999 DISCN No 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 3 of 3 entries

Market Dynamics and Financial Trajectory for Prometrium (Progesterone)

Introduction to Prometrium

Prometrium, a brand name for micronized progesterone, is a crucial hormone therapy used in various medical applications, including menopause, dysfunctional uterine bleeding, and endometrial cancer. Here, we delve into the market dynamics and financial trajectory of Prometrium and the broader progesterone market.

Market Size and Growth

The global progesterone market, which includes Prometrium, is projected to experience significant growth. As of 2024, the market size is estimated at USD 1.74 billion and is expected to reach USD 2.67 billion by 2029, growing at a CAGR of 8.92% during the forecast period[1].

By 2034, the market is anticipated to expand further, reaching USD 4.80 billion with a CAGR of 12.3% from 2024 to 2034[3].

Regional Market Performance

North America is the largest market for progesterone, driven by the high adaptability of advanced treatments and a significant disease burden, including rising cases of uterine body cancers and a growing population of menopausal women. The region is expected to continue dominating the market due to these factors and the strategic efforts of market players to enhance their R&D capabilities[1][3][4].

Asia Pacific is identified as the fastest-growing region, with a high CAGR expected over the forecast period. This growth is fueled by increasing healthcare awareness and the expanding pharmaceutical sector in the region[1].

Product Segments

The progesterone market is segmented into natural and synthetic progesterone. Natural progesterone, which includes products like Prometrium, is expected to witness lucrative growth. Drugs such as Crinone and Prometrium are major contributors to the revenue in this segment due to their widespread use and prescription rates[1].

Modes of Delivery

The market is also segmented by mode of delivery, with injectable, oral, and suspended forms being key categories. The injectable segment is set to acquire a significant market share, highlighting the preference for this mode of delivery in various therapeutic applications[3][4].

Applications

Prometrium and other progesterone products are used in several applications, including:

  • Menopause: For hormone replacement therapy to alleviate symptoms.
  • Dysfunctional Uterine Bleeding: To regulate menstrual cycles.
  • Endometrial Cancer: As part of the treatment regimen.
  • Contraception: In some cases, as part of hormonal contraceptives.
  • Hyperplastic Precursor Lesions: To prevent the progression of these lesions[1][4].

Impact of COVID-19

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

Key Players and Market Competition

Major players in the progesterone market include Cadila Pharmaceuticals, Alkem Labs, Cipla Limited, Lupin Limited, and Glenmark Pharmaceuticals. These companies are engaged in various strategies such as collaborative efforts to enhance R&D capabilities and launch new products to meet the growing demand for progesterone[1].

Financial Performance

The financial performance of Prometrium and similar products is robust. For instance, the Prometrium brand and its generic versions had U.S. sales of approximately $153 million for the twelve months ending in February 2017[5].

Regulatory and Compliance Aspects

Ensuring compliance with stringent regulatory requirements is crucial for market entry and growth. Companies like Dr. Reddy's Laboratories have successfully launched generic versions of Prometrium after receiving approval from regulatory bodies such as the U.S. FDA[5].

Future Outlook and Strategies

To capitalize on the growing demand, market players are focusing on:

  • Innovative Formulations: Developing new and more effective formulations of progesterone.
  • Market Expansion: Expanding into regions with high disease burdens.
  • Strategic Partnerships: Collaborating on R&D to enhance product offerings and meet growing demand[3][4].

Key Takeaways

  • The progesterone market, including Prometrium, is expected to grow significantly, driven by increasing demand for hormone replacement therapy and treatment of various health conditions.
  • North America dominates the market, while Asia Pacific is the fastest-growing region.
  • Natural progesterone products, such as Prometrium, are expected to witness healthy growth.
  • The market is driven by the rising prevalence of conditions like breast cancer, uterine body cancers, and menopausal symptoms.

FAQs

1. What is the current market size of the progesterone market? The progesterone market size is estimated at USD 1.74 billion in 2024[1].

2. Which region is expected to dominate the progesterone market? North America is expected to hold the largest share of the progesterone market[1][3][4].

3. What is the fastest-growing region in the progesterone market? Asia Pacific is the fastest-growing region in the progesterone market[1].

4. What are the primary applications of Prometrium and other progesterone products? Primary applications include menopause, dysfunctional uterine bleeding, endometrial cancer, contraception, and hyperplastic precursor lesions[1][4].

5. How has COVID-19 impacted the progesterone market? COVID-19 increased the demand for progesterone due to its potential in improving clinical outcomes for certain hospitalized patients, contributing to market growth during the pandemic[1].

Cited Sources

  1. Mordor Intelligence: Progesterone Market - Growth, Report, Applications & Manufacturers.
  2. FDA: Prometrium Label.
  3. PR Newswire: Progesterone Therapy in Demand for Personalized Medicine.
  4. Straits Research: Progesterone Market to be Worth USD 4.14 billion by 2032.
  5. BioSpace: Dr. Reddy's Laboratories Ltd. Announces The Launch Of Progesterone Capsules In The U.S. Market.

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