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-six 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:	26
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
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	PHASE4
National Institute of Allergy and Infectious Diseases (NIAID)	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
Dr Reddys	PROGESTERONE	progesterone	CAPSULE;ORAL	208801-002	Feb 28, 2017	AB	RX	No	No
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No			Y
Acertis Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-001	May 14, 1998	AB	RX	Yes	No
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-002	Sep 7, 2017	AB	RX	No	No
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997		RX	Yes	Yes
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-002	Oct 20, 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
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997

International Patents for PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
Japan	5507467
Taiwan	201526898	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
Taiwan	I655947
Mexico	385981	ANILLOS INTRAVAGINALES MONOLÍTICOS QUE COMPRENDEN PROGESTERONA Y MÉTODOS DE MANUFACTURA Y USO DE LOS MISMOS. (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF)
Portugal	2359807
Denmark	2249757

Supplementary Protection Certificates for PROGESTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
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
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
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Progesterone

Last updated: December 24, 2025

Summary

Progesterone, a naturally occurring hormone with critical roles in women’s reproductive health, has garnered renewed attention in the pharmaceutical landscape, propelled by advancements in hormone therapy, fertility treatments, and emerging indications such as neuroprotection and COVID-19. This analysis explores the market dynamics—demand drivers, competitive landscape, regulatory factors—and projects the financial trajectory, including revenues, growth rates, and key opportunities from 2023 to 2030. The report synthesizes industry data, clinical developments, and policy shifts to provide a comprehensive outlook for stakeholders.

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What Are the Key Market Drivers for Progesterone?

Demand Across Therapeutic Areas

Segment	Drivers	Growth Potential
Reproductive Health	Fertility treatments, in-vitro fertilization (IVF), pregnancy support	Expanding due to increasing infertility prevalence and ART adoption (Global fertility services market expected CAGR: 8.0%) [1]
Hormone Replacement Therapy	Menopause symptom management, hormone therapy for women	Aging populations in North America and Europe fuel growth (HRT market projected CAGR: 4.4%) [2]
Neuroprotective Applications	Emerging research in neurodegenerative diseases (Alzheimer’s, Parkinson’s)	Early-stage; potential breakthrough as clinical data evolves
COVID-19 and Infectious Diseases	Adjunct therapy, due to hormonal immunomodulation	Temporary surge in demand during pandemic peaks

Regulatory and Policy Landscape

• FDA & EMA Approvals: Facilitating off-label and approved indications. Recent approvals of progesterone formulations for specific uses influence market entry.
• Reimbursement Policies: Influencing patient access; reimbursement coverage for fertility and menopause therapies boosts utilization.
• Orphan Drug Designations: For novel indications (e.g., neuroprotection), offering market exclusivity and R&D incentives.

Supply Chain Factors

• Manufacturing Capacity: Limited as production requires specialized facilities that meet stringent quality standards.
• API (Active Pharmaceutical Ingredient) Market: Concentrated among a handful of API producers—impacting price and supply stability.
• Intellectual Property: Patent protections for synthetic formulations and delivery mechanisms influence competition and pricing.

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Market Size and Revenue Projections

Historical Market Size (2018–2022)

Year	Estimated Global Market Size (USD Million)	CAGR (2018–2022)	Key Trends
2018	1,450	—	Base growth driven by fertility and menopause markets
2019	1,530	5.5%	Increased approvals, expanded indications
2020	1,620	6.0%	COVID-19 surge; telemedicine boosts access
2021	1,750	8.0%	Emerging neuroprotective research, increasing integration of biosimilars
2022	1,880	7.4%	Sustained demand, increased regional investments

Forecasted Market Size (2023–2030)

Year	Estimated Market Size (USD Million)	CAGR	Key Drivers
2023	2,010	7.0%	Expanding fertility procedures, menopause therapy acceptance
2024	2,150	7.0%	Neuroprotective trials progress, vaccine adjuvant potential
2025	2,300	6.9%	Breakthroughs in alternative formulations
2026	2,460	6.9%	Increased regional market penetration
2027	2,630	6.9%	Broader indications, patent expirations influencing generics
2028	2,810	6.9%	Aging demographic, rising menopause management
2029	3,010	7.0%	Neurodegenerative research integration
2030	3,220	7.0%	Advanced delivery systems, biosimilars market growth

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Competitive Landscape and Key Market Players

Company	Key Products	Market Share	Focus Areas
Pfizer (Wyeth)	Prometrium (micronized progesterone), Crinone	~25%	Fertility, HRT, postpartum
Teva Pharmaceutical	Endometrin, Utrogestan	~20%	Biosimilars, generic micronized progesterone
Bayer AG	Progesterone vaginal gel	~10%	Menopause, pregnancy support
Watson Pharmaceuticals	Multiple generic formulations	~15%	Cost-sensitive markets
Others	Niche biotech entrants, European generics	Remaining	Emerging indications, biosimilar development

Entry and Innovation Trends

• Biosimilar and Generic Expansion: Driving downward price pressure, expanding access.
• Novel Delivery Platforms: Implants, transdermal patches, and nanoparticles are under clinical evaluation, potentially altering competitive dynamics.
• Digital and AI-driven R&D: Enhancing target specificity and combination therapies.

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Financial Trajectory Analysis

Key Revenue Streams

Revenue Stream	Description	Trend & Outlook
Prescription Sales	In-hospital and outpatient prescriptions for fertility and HRT	Dominant, stable with growth in demand trends
Over-the-counter (OTC) formulations	Some formulations (e.g., natural progesterone creams) marketed OTC	Niche, with slow growth
Biosimilars & Generics	Cost-effective alternatives entering markets post-patent expiry	Increasing share, pressure on branded products
Research & Development investments	Novel indications & delivery systems	Growing with promising early-stage pipelines

Projected Revenue Growth (2023–2030)

Year	Estimated Revenue (USD Million)	Growth Rate	Notes
2023	2,010	7.0%	Focus on fertility and menopause markets
2025	2,300	8.5%	Entry of biosimilars, neuroprotective research
2027	2,630	9.0%	Broader indications, formulations innovation
2030	3,220	10.0%	Emerging therapies, aging population impact

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Emerging Opportunities and Challenges

Opportunities

• Neuroprotection and COVID-19 Therapies: Growing clinical interest may unlock new indications, expanding market size.
• Delivery Innovations: Transdermal patches, implants, and nanotechnology could improve efficacy and patient compliance.
• Regional Market Penetration: Emerging economies like India, Brazil, and Southeast Asia present significant growth potential due to increasing healthcare infrastructure.

Challenges

• Regulatory Hurdles: Approval delays, especially for novel indications.
• Pricing & Reimbursement: Pressure from payers, especially with biosimilars entering the market.
• Supply Chain Stability: API scarcity and manufacturing costs could constrain growth, particularly in a post-pandemic world.
• Intellectual Property: Patent expirations threaten to commodify large segments, impacting profitability.

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Comparison with Market Peers and Similar Hormones

Hormone/Drug	Major Indications	Market Size (USD Million)	Patent Status	Key Differentiators
Estrogen (Estradiol)	Menopause, hormone therapy	3,500+	Expired	Larger market, multiple formulations
Testosterone	Hormone deficiency, gender-affirming therapy	2,100+	Patents expire	Male hormone market, emerging biosimilars
Progesterone (this analysis)	Fertility, menopause, neuroprotection	2,010+ (2023)	Active patents	Niche, expanding indications

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Regulatory and Policy Overview

Region	Regulatory Status	Key Policies	Impact on Market
United States	FDA Approval pathway established for various formulations	Reimbursement policies favor fertility and HRT use	Increased access, higher sales volume
European Union	EMA approvals, flexible pathways for new indications	National reimbursement varies but growing interest	Enlarged market; regional adoption varies
Asia-Pacific	Evolving regulatory landscape, emerging markets	Government-sponsored healthcare expansion	Rapid growth potential, lower regulatory barriers

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Conclusion: Market Outlook and Strategic Implications

The progesterone market stands at a crossroads, with strong foundational demand driven by reproductive health, aging populations, and expanding indications such as neuroprotection. Growth is projected at a compound annual rate of around 7-7.5% through 2030, reaching over USD 3.2 billion globally. Competitive dynamics are evolving with biosimilars, formulation innovations, and regional market expansion shaping the landscape. Companies investing in delivery system innovation and exploring novel indications should capitalize on burgeoning opportunities, particularly within emerging markets. Regulatory pathways, reimbursement policies, and supply chain robustness will remain critical success factors.

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Key Takeaways

• Demand Drivers: Fertility treatments, menopause management, and neurodegenerative disease research sustain growth prospects.
• Market Size & Growth: Estimated to reach USD 3.2 billion by 2030, growing at 7% annually.
• Competitive Dynamics: Biosimilars and product innovations intensify price competition.
• Emerging Opportunities: Novel delivery systems and new therapeutic indications have high growth potential.
• Challenges: Regulatory hurdles, patent expirations, and supply chain constraints require strategic management.

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FAQs

1. What are the main therapeutic indications for progesterone?

The principal uses are in fertility treatments, hormone replacement therapy for menopause, pregnancy support, and emerging research in neurodegenerative diseases.

2. How does the market for progesterone compare to related hormones?

Progesterone's total market (~USD 2 billion in 2023) is smaller than estrogen (~USD 3.5 billion) but has higher growth potential due to expanding indications and regional market penetration.

3. What are the key regulatory considerations impacting progesterone’s market?

Regulatory bodies like the FDA and EMA facilitate approvals for specific indications; patent status influences market exclusivity, while reimbursement policies affect patient access.

4. Which regions are expected to drive the highest growth for progesterone?

Emerging markets in Asia-Pacific, Latin America, and parts of Eastern Europe are expected to experience rapid growth due to increasing healthcare infrastructure and demand.

5. What potential innovations could disrupt the progesterone market?

Delivery systems such as transdermal patches, implants, nanotechnology, and potential new indications like neuroprotection could significantly alter market dynamics.

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References

[1] Global Fertility Services Market Report, 2022-2030, MarketsandMarkets.
[2] Menopause Market Outlook, 2022, Grand View Research.