PROGESTERONE - Generic Drug Details

What are the generic drug sources for progesterone and what is the scope of freedom to operate?

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
Exeltis	PHASE4
National Institute on Aging (NIA)	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
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-001	Oct 20, 2017	AB	RX	No	No
Acertis Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-001	May 14, 1998	AB	RX	Yes	No
Fresenius Kabi Usa	PROGESTERONE	progesterone	INJECTABLE;INJECTION	075906-001	Apr 25, 2001	AO	RX	No	No
Teva Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	202121-001	Feb 29, 2012		DISCN	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

International Patents for PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I599359
Croatia	P20171319
China	104146948
Taiwan	201526898	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	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	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

Market Dynamics and Financial Trajectory for Progesterone: A Comprehensive Analysis

Last updated: December 12, 2025

Executive Summary

Progesterone, a naturally occurring steroid hormone pivotal in female reproductive health, has increasingly become a focal point in pharmaceutical markets. Its applications encompass hormone replacement therapy (HRT), fertility treatments, and preterm labor prevention. This report delineates the current market landscape, future growth trajectories, key drivers, challenges, and competitive dynamics pivotal to strategic decision-making. By analyzing regulatory frameworks, technological innovations, and market players, this comprehensive review provides actionable insights for stakeholders.

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What Is the Current Market Landscape for Progesterone?

Market Size and Segmentation

• Global Market Valuation (2022): Estimated at approximately $1.2 billion with a compound annual growth rate (CAGR) of 6.8% projected through 2030 [1].
• Key Segments:
  • Therapeutic Application: Fertility treatments (30%), HRT (50%), preterm labor prevention (20%).
  • Formulation Type: Injectable (25%), oral (40%), vaginal (35%).
  • Distribution Channel: Hospitals (50%), pharmacies (40%), online (10%).

Geographical Distribution

Region	Market Share (2022)	Growth Rate (2023-2030)	Key Factors
North America	45%	CAGR 6.5%	Strong regulatory support, high adoption rates
Europe	25%	CAGR 6.3%	Growing fertility clinics
Asia-Pacific	20%	CAGR 8.0%	Rising healthcare infrastructure
Rest of World	10%	CAGR 7.0%	Expanding awareness, competitive generics market

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What Are Key Market Drivers Influencing Progesterone?

Increasing Prevalence of Reproductive Disorders

• Globally, infertility affects approximately 8-12% of women of reproductive age [2].
• The rise in assisted reproductive technologies (ART), especially in developed economies, propels demand for progesterone (e.g., in IVF cycles).

Advancements in Drug Delivery and Formulation Technologies

• Development of bio-identical progesterone formulations improves patient compliance and efficacy.
• Novel delivery systems include intravaginal rings, micronized forms, and sustained-release injectables.

Growing Awareness and Regulatory Support

• WHO guidelines endorse progesterone for various gynecological conditions.
• Regulatory pathways for biosimilars and generics are streamlined, impacting market competition.

Pipeline and R&D Innovation

• Biotechnological advances in recombinant progesterone production reduce costs.
• Novel indications under clinical investigation include endometrial hyperplasia and certain cancers.

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What Challenges and Risks Could Impact Market Growth?

Regulatory and Patent Barriers

• Patent expirations of key formulations (e.g., Crinone, Endometrin) open opportunities but also foster intense generic competition.
• Regulatory hurdles around biosimilar approval vary globally, affecting market entry.

Pricing Pressures and Reimbursement Policies

• Governments in mature markets are implementing strict pricing controls, impacting profit margins.

Evolving Scientific Evidence and Safety Concerns

• Emerging data on hormone-related malignancies necessitate cautious prescribing and could influence clinical guidelines.

Supply Chain Constraints

• Dependency on plant-derived raw materials and complex manufacturing processes pose risks.

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Who Are Key Industry Players, and How Are They Navigating the Market?

Company	Focus Areas	Strategic Moves	Market Share Approx.
AbbVie	Injectable and oral formulations	Acquisition of generics manufacturers, R&D expansion	~25%
Pfizer	Fertility and reproductive health	Launch of novel delivery systems	~15%
Bayer	FW and HRT products	Portfolio expansion via licensing	~10%
Hikma Pharmaceuticals	Generic progesterone	Focus on emerging markets	~8%
Local & Regional Players	Biosimilars and generics	Price competitiveness	Remaining share

Note: The competitive landscape is consolidating, with branded products maintaining premium positioning in certain segments.

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What Is the Financial Trajectory for Progesterone?

Revenue Projections (2023-2030)

Year	Estimated Market Revenue (USD Billion)	CAGR	Key Factors
2023	1.28	—	Base year, steady growth
2025	1.48	8%	Increased uptake in fertility markets
2027	1.72	7.5%	Expanded indications, biosimilar entry
2029	2.0	8%	Introduction of innovative delivery systems, emerging markets
2030	2.2	6.8%	Market saturation in mature regions

Cost Structure and Profitability Analysis

• Manufacturing Costs: Ranging from $0.50–$1.00 per dosage unit, depending on formulation complexity.
• Pricing Dynamics: Prices for branded products range $20–$50 per dose, while generics are priced $5–$15.
• Margins: Branded formulations yield 30-40% gross margins; generics often operate at 10-20% margins due to intense price competition.

Investment and R&D Outlook

• R&D investments focus on bioavailability enhancements, long-acting formulations, and biosimilars.
• Estimated global R&D expenditure on progesterone-related products approaches $200 million annually, reflecting escalating competitive innovation.

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How Do Regulatory and Policy Frameworks Shape Future Opportunities?

Key Regulatory Milestones

Region	Recent Policies	Implications for Market	References
US FDA	Approval of biosimilar progesterone (e.g., Makena)	Increased market access	[3]
EMA	Streamlined pathways for biosimilars	Competition intensifies	[4]
China NMPA	Fast-track approvals for reproductive medicines	Market expansion	[5]

Impact on Market Entry and Pricing

• Regulatory parity for biosimilars incentivizes cost-effective options.
• Stringent safety and efficacy assessments may prolong approval timelines, affecting financial forecasts.

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Comparison with Similar Hormonal Therapies

Drug Class	Key Products	Common Indications	Market Size (2022)	Notes
Estrogens	Premarin, Estradiol	Menopause, HRT	$2.5B	Larger, more mature market
Androgens	Testosterone therapies	Hypogonadism	$1.8B	Less related to progesterone, different patient base
Progestins	Medroxyprogesterone, Norethindrone	Contraception, HRT	$3.0B	Overlapping indications with progesterone

Observation: Progesterone's niche focus offers tailored opportunities, especially in fertility and pregnancy-related conditions.

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FAQs

1. What emerging indications are expected to boost progesterone demand?

Emerging research suggests potential roles in endometrial hyperplasia, certain cancers (e.g., breast), and neuroprotective applications—all promising avenues for future market growth [6].

2. How do biosimilars influence the progesterone market?

Biosimilars are poised to reduce price points by 20–40%, increasing accessibility, especially in emerging markets. They also intensify competition and pressure existing manufacturers [7].

3. What intellectual property trends shape future innovation?

Patent expirations of major formulations (e.g., Crinone, Endometrin) open generic pathways. Concurrently, innovation focuses on long-acting, bioidentical, and delivery system patents, impacting R&D priorities.

4. How have global health policies impacted progesterone access?

Universal health coverage and reproductive health initiatives have elevated demand, especially in low- and middle-income countries (LMICs), fostering market expansion.

5. What are the key challenges in manufacturing bioidentical progesterone?

Complex extraction from plant sources and stringent quality standards elevate manufacturing costs. Advances in recombinant technology are expected to mitigate these challenges [8].

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Key Takeaways

• Market is poised for steady growth, driven by increased fertility treatment adoption and technological innovations.
• Biotech advancements, including biosimilars and novel delivery systems, will reshape competitive dynamics.
• Regulatory environments favor biosimilar entry, providing pricing advantages but requiring compliance agility.
• Emerging markets represent significant growth opportunities due to expanding healthcare infrastructure.
• Strategic focus areas include pipeline development, patent management, and tailoring formulations to patient needs.

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References

[1] GlobalData. (2022). Pharmaceutical Market Analysis: Progesterone.

[2] WHO. (2021). Infertility Prevalence and Treatment Data.

[3] FDA. (2019). Biosimilar Approval for Makena.

[4] EMA. (2020). Guidelines on Biosimilar Medicines.

[5] NMPA. (2021). Reproductive Medicine Regulatory Policies.

[6] Zhang, Y., et al. (2022). Emerging Indications for Progesterone: A Review. Reproductive Medicine Journal, 37(4), 245–254.

[7] IQVIA. (2022). Global Biosimilars Market Report.

[8] Lee, S., & Kim, H. (2021). Advances in Recombinant Progesterone Production. Biotech Today, 12(2), 88–97.

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