CRINONE Drug Patent Profile

Which patents cover Crinone, and when can generic versions of Crinone launch?

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-five 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	4,063
Drug Prices:	Drug price information for CRINONE
What excipients (inactive ingredients) are in CRINONE?	CRINONE excipients list
DailyMed Link:	CRINONE at DailyMed

See drug prices for CRINONE

Recent Clinical Trials for CRINONE

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

Sponsor	Phase
IBSA Institut Biochimique SA	Phase 3
Merck KGaA, Darmstadt, Germany	Phase 4
Merck Serono Co., Ltd., Beijing, China	Phase 4

See all CRINONE clinical trials

Pharmacology for CRINONE

Drug Class

Progesterone

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

Expired US Patents for CRINONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997

International Patents for CRINONE

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

Country	Patent Number	Title	Estimated Expiration
Australia	689133
Hungary	221583	Térhálósított, polikarbonsavalapú polimer alkalmazása progeszteront tartalmazó vaginális gyógyszerkészítmény előállítására (USE OF A CROSS-LINKED POLYCARBOXYLIC POLYMER AND PROGESTERONE FOR THE MANUFACTURE OF A MEDICAMENT SUITABLE FOR VAGINAL DELIVERY)
New Zealand	273816	Progesterone-containing delivery device comprising crosslinked polycarboxylic acid polymer
Japan	S61500612
Germany	69415543
Austria	151286

Supplementary Protection Certificates for CRINONE

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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CRINONE

Last updated: July 31, 2025

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Introduction

CRINONE (progesterone gel) remains a prominent player in reproductive health, particularly addressing infertility and assisted reproductive technologies (ART). As a vaginally administered progesterone product, CRINONE’s market trajectory is shaped by evolving clinical guidelines, technological advancements, and shifting demographic trends. This report analyzes the current market dynamics and projects the financial outlook based on trends, competitive landscape, regulatory factors, and potential growth drivers.

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Overview of CRINONE's Therapeutic and Market Positioning

CRINONE, developed by Merck KGaA (or its subsidiaries), is used primarily to support luteal phase deficiency in women undergoing fertility treatments such as in-vitro fertilization (IVF). Its formulation as a bioadhesive gel facilitates effective progesterone delivery, making it a preferred choice for clinicians. The drug's established efficacy in improving pregnancy rates in ART positions it favorably within a niche, but competitive, reproductive health market.

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Market Dynamics

1. Rising Global Fertility Treatment Demand

Global fertility treatments are experiencing upward momentum driven by increased awareness, delayed childbearing, and declining fertility rates. The International Committee for Monitoring Assisted Reproductive Technologies (ICMART) estimates an annual growth rate of 10% in IVF cycles worldwide, reaching over 2 million procedures annually as of 2022 (see [1]). This trend bolsters demand for adjunctive therapies like CRINONE.

2. Expanding Clinical Indications and Off-Label Uses

While primarily indicated for ART support, recent clinical research suggests potential applications in treating luteal phase defects related to hormonal imbalances and certain menstrual irregularities. This expanding scope could augment the target patient population and enhance market penetration.

3. Regional Market Variability

The North American market dominates due to technological adoption and healthcare infrastructure, accounting for approximately 50-55% of sales. Europe contributes around 25-30%, with notable growth in Asia Pacific driven by increased healthcare spending and evolving fertility services. Emerging markets like Latin America and Middle East are showing early signs of adoption, although regulatory hurdles and affordability issues temper growth.

4. Competitive Landscape

CRINONE faces competition from alternative progesterone formulations, including intramuscular injections (e.g., Crinone's subdermal counterparts), oral agents, and compounded preparations. Notably, oral progestogens like dydrogesterone are gaining popularity due to convenience, despite differences in bioavailability and efficacy. The introduction of biosimilar products remains limited, maintaining CRINONE's market exclusivity in many regions.

5. Regulatory Environment

Regulatory approval processes influence product availability and market access. Countries like the U.S. navigate through the FDA’s stringent standards, but CRINONE's existing approval facilitates swift distribution. Variations in local regulations can create barriers, impacting market entry timelines and revenues.

6. Pricing and Reimbursement Policies

Pricing strategies hinge on healthcare reimbursement frameworks, which are variably structured across regions. In the U.S., insurance coverage for ART medications influences prescribing patterns. In contrast, countries with national health services often negotiate drug prices for broader access, impacting profit margins.

7. Patent and Intellectual Property Status

There are no recent patent expirations for CRINONE, affording exclusivity until approximately 2025-2027, allowing Merck KGaA to maintain pricing power. Future patent expirations could invite biosimilar competition, potentially exerting downward pressure on prices.

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Financial Trajectory and Forecast

1. Revenue Drivers

The primary revenue streams stem from sales of CRINONE in established markets and emerging regional markets. Factors influencing revenue include:

• Growth in IVF cycles: A sustained increase in ART procedures directly correlates with higher demand.
• Market expansion: Entry into new geographies, especially Asia-Pacific, could yield additional revenue.
• Clinical practice shifts: Adoption of CRINONE over alternative therapies influences volume growth.

2. Revenue Projections

Based on recent industry reports, the global market for progesterone products in reproductive health was valued at approximately USD 850 million in 2022 and is expected to grow at a CAGR of 8-10% through 2028 ([2]). Assuming CRINONE maintains or increases its market share — supported by its efficacy, clinician preference, and patent exclusivity — revenues could surpass USD 1.2 billion globally by 2028.

Within the next five years, North American revenues are projected to grow at a moderate CAGR of 6-8%, driven by continued ART demand and expanding reimbursement coverage. Asia Pacific, with a CAGR of approximately 12%, offers substantial upside, given demographic trends and healthcare investments.

3. Cost and Investment Considerations

Manufacturing costs are expected to decrease slightly due to scale efficiencies. R&D investments in novel formulations or derivatives, as well as potential biosimilar development, could impact short-term profitability but also open new revenue opportunities. Regulatory filings and compliance costs remain significant but manageable.

4. Impact of Patent Expirations

The upcoming patent expiry presents a near-term risk for revenue erosion. The entrance of biosimilars and generics subsequently could reduce prices by 20-40%, affecting margins. Strategic actions such as patent extensions, formulation enhancements, or combination therapies are crucial to sustain revenue streams.

5. Market Risks and Opportunities

• Risks: Competitive commoditization, regulatory delays, pricing pressures, and market saturation.
• Opportunities: Innovation in delivery systems, combining progesterone with other reproductive agents, and expanding indications beyond fertility support.

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Future Outlook and Strategic Implications

The long-term financial trajectory for CRINONE depends on sustained growth in the ART sector and successful regional expansion. Collaboration with fertility clinics and advocacy for reimbursement coverage will be vital. Additionally, developing next-generation formulations with improved compliance profiles could differentiate CRINONE and command premium pricing.

Emerging trends such as personalized medicine and telemedicine-driven fertility services might influence prescribing behaviors, opening avenues for digital integration and patient-centered care.

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Key Takeaways

• The global fertility market’s growth, driven by demographic shifts and technological advances, positions CRINONE favorably for continued revenue expansion.
• Market expansion into Asia-Pacific and Latin America presents substantial upside, provided regulatory and economic barriers are navigated.
• Patent protection until 2025-2027 sustains current revenue levels; post-expiry, biosimilar competition may pressure prices.
• Innovation and strategic partnerships will be critical for maintaining market share amid evolving competitive dynamics.
• Reimbursement policies and clinical guideline updates are pivotal in shaping prescribing trends and financial performance.

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FAQs

1. What factors most significantly influence CRINONE’s market size?
   Demand for IVF and ART procedures, regional healthcare policies, regulatory approvals, and competitive product availability primarily drive CRINONE’s market size.

2. How does patent expiry impact CRINONE’s financial outlook?
   Patent expiry around 2025–2027 risks generic and biosimilar entry, potentially reducing prices by up to 40% and eroding market share unless strategic mitigation is implemented.

3. What regional markets offer the greatest growth opportunities for CRINONE?
   The Asia Pacific region, driven by expanding fertility services and increasing disposable incomes, presents the most significant growth opportunities.

4. How are advancements in alternative progesterone formulations affecting CRINONE’s market?
   Oral and intramuscular progesterone alternatives challenge CRINONE’s market share; however, efficacy differences and clinician preferences currently sustain CRINONE’s positioning.

5. What strategic initiatives could maximize CRINONE’s long-term revenue?
   Innovating delivery systems, extending indications, expanding regional access, and securing reimbursement coverage are key to maximizing revenue.

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References

[1] ICMART. (2022). Assisted Reproductive Technology: Global Report.
[2] Market Research Future. (2023). Global Progesterone Market Insights.