PROGESTERONE - Generic Drug Details

What are the generic sources for progesterone and what is the scope of patent protection?

Progesterone is the generic ingredient in six branded drugs marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Acertis Pharms, Abbvie, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in twenty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Progesterone has fifty-four patent family members in twenty-five countries.

There are fifty-seven drug master file entries for progesterone. Twenty-five suppliers are listed for this compound.

Summary for PROGESTERONE

International Patents:	54
US Patents:	3
Tradenames:	6
Applicants:	18
NDAs:	21
Drug Master File Entries:	57
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,215
Patent Applications:	7,663
Drug Prices:	Drug price trends for PROGESTERONE
Drug Sales Revenues:	Drug sales revenues for PROGESTERONE
What excipients (inactive ingredients) are in PROGESTERONE?	PROGESTERONE excipients list
DailyMed Link:	PROGESTERONE at DailyMed

See drug prices for PROGESTERONE

See drug sales revenues for PROGESTERONE

Recent Clinical Trials for PROGESTERONE

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

Sponsor	Phase
University of British Columbia	NA
National Institute on Aging (NIA)	PHASE4
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	PHASE4

See all PROGESTERONE clinical trials

Pharmacology for PROGESTERONE

Drug Class

Progesterone

Medical Subject Heading (MeSH) Categories for PROGESTERONE

Progestins

Anatomical Therapeutic Chemical (ATC) Classes for PROGESTERONE

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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
Accord Hlthcare	PROGESTERONE	progesterone	INJECTABLE;INJECTION	217707-001	Nov 21, 2023		DISCN	No	No
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	AB	RX	Yes	Yes
Acertis Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-003	Oct 15, 1999		DISCN	No	No
Lilly	PROGESTERONE	progesterone	INJECTABLE;INJECTION	009238-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-001	Sep 7, 2017	AB	RX	No	No

Expired US Patents for PROGESTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	7,393,543
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997	4,615,697
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	7,320,800
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997	5,543,150
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	7,300,664

International Patents for PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201491815
South Korea	20100133969
China	102098991
Singapore	187529	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF
New Zealand	587758	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF

Supplementary Protection Certificates for PROGESTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Progesterone

Last updated: July 27, 2025

Introduction

Progesterone, a naturally occurring steroid hormone, plays a critical role in female reproductive health, including menstrual cycle regulation, pregnancy maintenance, and embryogenesis. Its pharmaceutical application spans hormone therapy, fertility treatments, and neuroprotective indications. The evolving landscape of this drug exemplifies significant market dynamics influenced by technological advancements, regulatory decisions, and demographic shifts. Understanding its financial trajectory involves analyzing global demand patterns, manufacturing trends, competitive positioning, and emerging therapeutic indications.

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Global Market Overview

The progesterone market has experienced steady growth, driven predominantly by increasing prevalence of infertility, menopause management, and pregnancy-related complications. The global market was valued at approximately USD 1.5 billion in 2022 and is projected to reach USD 2.3 billion by 2030, growing at a compound annual growth rate (CAGR) of around 6% [1].

This growth stems from heightened awareness and acceptance of hormone replacement therapy (HRT), expanding use in assisted reproductive technologies (ART), and novel delivery methods, all contributing to broader accessibility and efficacy. North America remains the largest market, attributed to advanced healthcare infrastructure and high adoption rates, followed by Europe and Asia-Pacific regions, where demographic shifts and increasing healthcare investments fuel expansion.

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Market Drivers

Rising Incidence of Infertility and Pregnancy Complications

Infertility affects approximately 8-12% of reproductive-age couples worldwide [2]. Progesterone therapy facilitates luteal phase support in assisted reproductive techniques like in vitro fertilization (IVF), emphasizing its critical role in fertility treatments. As IVF procedures become more widespread, demand for pharmaceutical-grade progesterone surges correspondingly.

Advancements in Drug Delivery Technologies

Traditional intramuscular injections have been complemented by intravaginal gels, vaginal inserts, and oral formulations, reducing patient discomfort and improving compliance. Novel delivery systems such as biodegradable implants and nano-formulations enhance bioavailability, broadening therapeutic options [3].

Increased Use in Menopause and HRT

The aging global population sustains high demand for hormone replacement therapy to alleviate menopausal symptoms. Progesterone, combined with estrogen, reduces endometrial hyperplasia risk, solidifying its role in women's health management [4].

Regulatory Approvals and Patent Expirations

Approval of biosimilar and generic progesterone formulations in various markets has increased accessibility and reduced costs, stimulating market growth. Patent expirations of branded products have opened opportunities for competition, further expanding the market landscape [5].

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Market Challenges

Regulatory and Safety Concerns

Although progesterone is well-established, safety concerns—particularly relating to breast cancer risk and cardiovascular effects—prompt regulatory scrutiny. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) closely monitor safety profiles, impacting product approval and market expansion.

Pricing and Reimbursement Dynamics

Pricing pressures from governments, insurers, and generics influence profitability. Reimbursement policies, especially in emerging markets, can restrict market penetration unless supported by evidence of cost-effectiveness.

Market Saturation and Competition

The proliferation of biosimilars and generic formulations intensifies competition, leading to price erosion. Larger pharmaceutical firms are investing in niche indications and delivery innovations to differentiate their products.

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Emerging Therapeutic and Market Opportunities

Neuroprotective and Concussion Treatment

Recent research indicates progesterone’s neuroprotective effects, prompting clinical trials for traumatic brain injury (TBI) and neurodegenerative conditions. If approved, these indications could significantly diversify the market and increase revenue streams [6].

Personalized Medicine and Biomarker Development

Advancements in genomic and biomarker research enable personalized hormone therapy. Tailored treatments can improve efficacy and safety, driving higher adoption and premium pricing.

Expansion in Developing Markets

Asia-Pacific and Latin America exhibit growing healthcare infrastructure and unmet medical need. Local manufacturing and strategic partnerships facilitate market penetration, boosting revenues and broadening access.

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Financial Trajectory Analysis

Revenue Projections and Market Share

Based on current growth rates, major pharmaceutical companies specializing in hormone therapies can expect a compounded revenue increase between 5-7% annually over the next decade. Leading players such as Pfizer, Merck, and Crinone (a progesterone gel brand) are expected to dominate, albeit facing increasing competition from biosimilars and regional manufacturers.

Research & Development Investment

Investment in novel delivery systems, biosimilars, and new therapeutic indications is crucial. R&D budgets dedicated to progesterone are projected to grow at a CAGR of approximately 8%, reflecting the importance of innovation for staying competitive.

Cost Dynamics and Margins

Manufacturing costs for traditional formulations remain relatively steady; however, innovations in production and packaging, along with regulatory compliance costs, influence margins. Economies of scale and regional manufacturing hubs are essential strategies for maintaining profitability.

Strategic Business Implications

Manufacturers pursuing licensing, partnerships, and acquisitions in emerging markets aim to capture early-stage growth. Patent expirations of conventional formulations necessitate continuous pipeline expansion, including biosimilars and novel indications, to sustain long-term revenues.

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Regulatory Environment and Policy Impact

Regulatory frameworks in major markets heavily influence financial performance. The FDA’s guidance on hormone therapy safety and EMA’s rigorous approval processes can introduce delays or restrict certain indications, affecting revenue projections.

Policies favoring biosimilar uptake and affordability initiatives further reshape competitive dynamics, potentially compressing profit margins but expanding volume sales [7].

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Conclusion

The progesterone market presents a balanced synergy of steady growth driven by demographic and technological factors, and challenges stemming from safety concerns, regulatory landscapes, and intense competition. Companies that innovate in delivery systems, diversify indications, and strategically penetrate emerging markets are positioned for favorable financial trajectories. Overall, the evolving landscape underscores the importance of ongoing research, regulatory agility, and market adaptation.

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Key Takeaways

• The global progesterone market anticipates a CAGR of approximately 6%, driven by fertility treatments, menopause management, and emerging indications.
• Innovations in drug delivery and expanding therapeutic areas will be pivotal in maintaining growth momentum.
• Competitive pressures from biosimilars and generics necessitate strategic R&D investments and diversification.
• Regulatory scrutiny on safety and reimbursement policies remains a critical determinant of market dynamics and profitability.
• Expansion opportunities lie within neuroprotective applications and emerging markets, offering substantial revenue potential.

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FAQs

1. What are the main therapeutic indications for pharmaceutical progesterone?
Progesterone is primarily used in fertility treatments (luteal support and assisted reproduction), hormone replacement therapy for menopausal women, and management of pregnancy-related complications such as recurrent miscarriage.

2. How is the market for progesterone expected to evolve in the next decade?
The market is projected to grow steadily at about 6% CAGR, driven by technological advances, expanding indications like neuroprotection, and increased adoption in emerging economies.

3. What are the recent innovations improving progesterone delivery?
Innovations include vaginal gels, sustained-release inserts, biodegradable implants, and nano-formulations, which enhance patient compliance and bioavailability.

4. How do patent expirations influence the progesterone market?
Patent expirations enable the entry of biosimilars and generics, which increase competition, decrease prices, and expand access, but may challenge branded drug profitability.

5. What emerging therapeutic applications could diversify the progesterone market?
Research into progesterone’s neuroprotective properties for TBI, stroke, and neurodegenerative diseases offers future market expansion opportunities beyond traditional women's health applications.

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References

[1] MarketsandMarkets. "Hormone Replacement Therapy Market by Type, Application, End User – Global Forecast to 2030." 2022.
[2] World Health Organization. "Infertility Fact Sheet," 2021.
[3] Taylor, S. et al. "Innovations in Hormone Delivery Systems," Journal of Pharmaceutical Sciences, 2020.
[4] North American Menopause Society. "Menopausal Hormone Therapy Guidelines," 2021.
[5] IMS Health Reports. "Impact of Patent Expirations on the Hormone Market," 2022.
[6] Stein, D. et al. "Progesterone’s Role in Neuroprotection," Neuroscience & Biobehavioral Reviews, 2021.
[7] European Medicines Agency. "Biosimilar & Generic Guidelines," 2022.