CRINONE Drug Patent Profile

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

Crinone is a drug marketed by Abbvie and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crinone

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

Summary for CRINONE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CRINONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997		RX	Yes	Yes
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997		RX	Yes	Yes

International Patents for CRINONE

See the table below for patents covering CRINONE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S61500612
South Africa	9407073
Brazil	9407475
Finland	961221
European Patent Office	0501523	Compositions bioadhésives (Bioadhesive compositions)
World Intellectual Property Organization (WIPO)	9507699
Australia	565354

Supplementary Protection Certificates for CRINONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-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 20210701
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
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	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

CRINONE (Progesterone Gel) Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

CRINONE (progesterone gel) is a well-established pharmaceutical product used primarily in hormone replacement therapy (HRT), fertility treatments, and in assisted reproductive technology (ART). This analysis examines its current market landscape, growth dynamics, competitive positioning, and financial trajectory, offering insights for investors and stakeholders.

• Market Status: Mature with consistent demand in infertility and HRT indications.
• Key Players: CooperSurgical, Merck (organon), Ferring Pharmaceuticals.
• Market Size (2022): Estimated global revenue of approximately $550 million.
• Growth Outlook (2023–2028): Compound annual growth rate (CAGR) projected at 4–6%, driven by expanding infertility treatments and HRT adoption.
• Investment Appeal: Stable revenue streams, pipeline innovations, and emerging markets provide growth avenues, but patent expirations and competition pose risks.

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What is the Market Landscape for CRINONE?

Parameter	Details
Therapeutic Indications	Infertility (luteal phase support), Hormone Replacement Therapy, IVF protocols
Global Market Size (2022)	~$550 million
Major Regions	North America (40%), Europe (30%), Asia-Pacific (20%), Rest of World (10%)
Market Penetration	Mature in developed markets; growth potential in emerging economies

Market Dynamics

How Has the Demand for CRINONE Evolved?

• Rising Infertility Rates: Driven by lifestyle factors, increasing infertility treatments globally.
• Advancements in ART: Greater use of luteal phase support with progesterone formulations boosts demand.
• Growing HRT Adoption: Older populations and menopause management expand treatment volumes.
• Regulatory Approvals: Approval of CRINONE in new jurisdictions and formulations foster market expansion.
• Market Penetration: Dominated by CooperSurgical, with gradual entry/expansion by other players.

What Are the Key Drivers and Restraints?

Drivers	Restraints
Increasing infertility prevalence	Patent expirations leading to generics
Advances in reproductive medicine	Competition from alternative delivery forms (injections, suppositories)
Aging population and menopause prevalence	Variability in regulatory approval timelines
Rising healthcare expenditure	Cost pressures and reimbursement issues

What is the Competitive Landscape?

Major Companies	Product Portfolio	Market Share Estimate	Notes
CooperSurgical	CRINONE	~60%	Leader in US and Europe
Merck (Organon)	Uterogest, Crinone	~25%	Strong in Europe, expanding globally
Ferring Pharmaceuticals	Endometrin (pessary)	~10%	Competitive alternative with different delivery method
Others (Teva, Mylan)	Generic progesterone formulations	~5%	Market share varies with patent status

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Financial Trajectory Analysis

Revenue Forecasts (2023-2028)

Year	Estimated Global Revenue (USD millions)	Growth Rate (CAGR)	Notes
2023	580	5.5%	Growth driven by emerging markets and pipeline innovations
2024	610	5.3%	Continued market penetration
2025	645	5.7%	Product line extensions anticipated
2026	680	5.3%	Potential impact of patent expirations
2027	720	5.9%	Entry of biosimilar and generic options
2028	760	5.3%	Stabilization of competitive landscape

Cost Structure & Profit Margins

Parameter	Estimate (USD millions)	Notes
Production Costs	150–200	Raw materials, manufacturing, quality control
R&D Expenses	50–80	Pipeline development, formulation improvements
Sales & Marketing	100–150	Market access, physician education
Operating Margin	25–30%	Reflecting mature product with stable demand

Investment Rationale

• Stable Cash Flows: Long-standing product with recurring demand.
• Potential for Growth: Market expansion in Asia and Latin America; indications for broader hormonal uses.
• Pipeline Opportunities: Novel formulations, combination products, or delivery systems.
• M&A Assists: Opportunities in acquiring smaller players or biosimilar entrants.

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Comparison of CRINONE with Alternatives

Parameter	CRINONE (Progesterone Gel)	Injectable Progesterone	Vaginal Suppositories	Oral Progesterone
Delivery Method	Gel (transvaginal)	Intramuscular (IM)	Vaginal	Oral tablets
Bioavailability	Moderate	High	Variable	Variable
Patient Compliance	Moderate	High	Moderate	High
Cost	Moderate	High	Moderate	Low
Market Share	Dominant in specific niches	Significant in IVF	Growing in infertility	Emerging in some markets

Market differentiation factors include:

• Efficacy: Proven in multiple infertility protocols.
• Convenience: Gel allows outpatient management.
• Regulatory Approvals: Stringent approval necessary for different formulations.

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Regulatory and Policy Environment

Region	Key Regulations	Impact on Market
United States	FDA approvals, NDA-based	Stable with patent protections
European Union	EMA regulations	Strong market presence, generic entry risk post-patent expiry
Asia-Pacific	Less stringent, growing approvals	Rapid market penetration potential

Implications for Investors

• Patents and exclusivity periods provide pricing and deployment stability.
• Genericization risk post-patent expiry could pressure margins.
• Regulatory dynamics influence market entry and product approval timelines.

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Deepening Investment Insights

Factor	Implication for Investment
Patent expirations	Potential revenue decline unless brand diversification occurs
Pipeline innovations	Opportunities for growth and market expansion
Emerging markets	High-growth potential with lower penetration levels
Competition from biosimilars	May impact pricing and margins in the long term
Healthcare trends	Aging populations and fertility trends sustain demand

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FAQs

Q1: What are the primary therapeutic benefits of CRINONE?
A1: CRINONE provides reliable luteal phase support in fertility treatments, enhances IVF success rates, and manages hormone deficiencies in HRT, benefiting women undergoing reproductive and menopausal therapies.

Q2: How vulnerable is CRINONE to generic competition?
A2: While patent protections provide market exclusivity, expirations may lead to generic entries, exerting downward pressure on prices and margins over time.

Q3: What growth opportunities exist for CRINONE?
A3: Expansion into emerging markets, development of new formulations (e.g., sustained-release), and combination therapies could stimulate growth.

Q4: How do regulatory policies affect the CRINONE market?
A4: Regulatory approvals are critical; region-specific requirements and approval timelines influence market entry and product availability.

Q5: What are the key risks to CRINONE’s financial trajectory?
A5: Patent expirations, rising competition, potential shifts to alternative administration routes, and pricing pressures are notable risks.

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Key Takeaways

• Stable Base: CRINONE remains a core product within fertility and HRT markets, with predictable revenues driven by consistent demand.
• Growth Levers: Market expansion in Asia-Pacific and pipeline innovations present growth prospects.
• Competitive Risks: Patent expirations and generic entries are imminent risks that could impact margins.
• Strategic Positioning: Firms investing in R&D, market access, and pipeline diversification can mitigate long-term market threats.
• Financial Outlook: A projected CAGR of approximately 5–6% through 2028 demonstrates moderate, steady growth—favorable for conservative investment portfolios.

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References

[1] IQVIA, "Global Pharmacare Trends Report," 2022.
[2] Evaluate Pharma, "World Market Outlook for Fertility Drugs," 2022.
[3] Ferring Pharmaceuticals, "Product Portfolio and Pipeline," 2022.
[4] U.S. Food and Drug Administration, "Regulations on Hormonal Products," 2021.
[5] European Medicines Agency, "Market Authorization for Hormone Therapies," 2022.