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. Thirty 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:	4,191
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 Serono Co., Ltd., Beijing, China	Phase 4
Merck Serono Co., Ltd.	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		DISCN	Yes	No
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
Austria	151286
Austria	82667
Australia	3618484
Australia	565354
Canada	1260832	COMPOSITIONS BIO-ADHESIVES, METHODES DE TRAITEMENT Y FAISANT APPEL (BIOADHESIVE COMPOSITIONS AND METHODS OF TREATMENT THEREWITH)

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
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
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	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

Last updated: July 30, 2026

CRINONE (Progesterone) Market Dynamics and Financial Trajectory: Sales Trends, Exclusivity Timelines, Competitive Pressure, and Key IP Risks

Executive summary

• CRINONE (progesterone vaginal gel; Actavis/ETHYPHARM legacy brands) remains a niche, indication-linked product with demand tied to female infertility and assisted reproductive technology (ART) workflows.
• The market is shaped by treatment-setting substitution (other vaginal progesterone gels/creams, progesterone capsules, injectable progesterone) and by availability and payer formulary positioning more than by blockbuster-type category growth.
• Commercial performance is structurally constrained by low single-product scale, supply/distribution hurdles common to specialty sterile and semi-solid products, and generic and authorized-duplicate availability for progesterone formulations.
• IP value is mostly tied to formulation, manufacturing, and method-of-use rather than broad active-ingredient exclusivity, so risk of generic price pressure is persistent.

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What is CRINONE and what clinical use drives demand?

CRINONE is a progesterone vaginal gel used to support luteal phase and early pregnancy regimens in specific settings, most prominently within ART protocols.

Which indications create the “real world” revenue base?

Featured demand drivers:

• IVF and fertility clinic prescribing for luteal support.
• Timing-specific dosing that aligns with clinic workflow and inventory practices.
• Patient persistence depends on regimen adherence and local alternatives (switching is common early when tolerability or payer coverage changes).

How does formulation matter in switching decisions?

Because CRINONE is administered vaginally, product choice is influenced by:

• Gel comfort/tolerability and applicator usability.
• Pharmacy acquisition cost and shipping reliability.
• Payer coverage rules by NDC, plan policy, and step edits.

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What market dynamics shape CRINONE pricing and volume?

CRINONE’s dynamics follow the typical profile of a specialty hormone product: limited scale, high substitution risk, and revenue sensitive to formulary access.

Substitution pressure from other progesterone options

Key competitive substitution vectors:

• Other vaginal progesterones (gels and inserts) that are therapeutically similar.
• Oral progesterone in capsule form in some settings.
• Intramuscular progesterone where clinicians prefer a different administration approach.

Switching accelerates when:

• Multiple agents are on the same formulary tier.
• Clinics standardize on a single product due to training and procurement.
• Clinician familiarity changes due to supply issues or reimbursement shifts.

Payer and channel effects

CRINONE sales depend heavily on:

• Specialty pharmacy distribution versus standard pharmacy channels.
• Contracting and rebates with PBMs and women’s health-focused distributors.
• Whether the product is treated as a preferred brand or quickly “tracked” to a less expensive alternative.

Tendering and purchasing behavior in fertility clinics

ART clinics often purchase based on:

• Total regimen cost (drug acquisition plus ancillary supplies).
• Bulk purchasing discounts.
• Reliability of product supply and lot availability.

Those factors can move demand between specific brands quickly after supply or pricing changes.

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How has CRINONE’s financial trajectory evolved over recent years?

A complete financial trajectory requires audited company-level segment reporting or proprietary sales datasets. The public domain does not provide a single consistent, fully citable set of annual CRINONE net sales across all years.

What can be stated from structure and market position:

• CRINONE is exposed to structural pricing erosion typical of progesterone brands where generics/authorized versions compete within the same administration route.
• Demand is more volatile than blockbuster products because ART volumes vary by clinic utilization and economic cycles, and because treatment protocols shift.

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What patents protect CRINONE, and what does that mean for long-term exclusivity?

CRINONE’s exclusivity profile is usually driven by secondary IP:

• Formulation composition and stability (including the gel vehicle system).
• Delivery system design (applicator and unit-dose technology).
• Manufacturing methods and scale-up parameters.
• Method-of-use for specific luteal support or early pregnancy protocols.

In practice, this means:

• The “patent wall” is narrower than for active-ingredient entities in many cases.
• Competitors can sometimes enter with bioequivalent progesterone products if they design around protected formulation or manufacturing.

How to interpret patent strength in this space

For progesterone vaginal products, patent estates often break down into:

• A small set of potentially enforceable formulation claims.
• A limited number of method-of-use claims.
• Manufacturing patents that may be harder to “see” unless tied to specific NDA/ANDA filing disclosures.

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When does CRINONE lose exclusivity, and how does the timeline affect competitive entry?

Key exclusivity risks for progesterone products typically include:

• Generic/authorized generic entry after formulation or method-of-use protections expire.
• Paragraph IV-type challenges in jurisdictions with patent linkage frameworks.
• Label evolution that changes whether a competitor can claim the same usage.

Timeline mechanics for market impact

• Entry dates matter less than how quickly channels switch after first availability.
• Fertility clinics and specialty pharmacies can switch within weeks if the competitor is stocked and reimbursable.
• Price erosion often begins at the first meaningful competitive presence, not at the earliest approval date.

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What generic entry risks exist for CRINONE?

Generic entry risks are persistent due to:

• The presence of multiple progesterone delivery options.
• The ease of switching when payer coverage changes.
• The likelihood that competitors can target non-core protected formulation features.

Risk is highest when:

• The brand’s prescribing is not locked to one unique formulation IP claim.
• Generic product supply is stable and priced aggressively.
• The competitor has favorable contracting in specialty channels.

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What is the Orange Book status of CRINONE?

A definitive Orange Book status requires exact NDA/ANDA identification and the listed patent numbers per dosage form and strength.

Without an identified Orange Book listing mapping, an accurate status summary cannot be produced.

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What patent litigation affects CRINONE or progesterone vaginal gel competitors?

Patent litigation in this category typically includes:

• Paragraph IV challenges tied to formulation and method-of-use patents.
• Settlement agreements that define launch timing.

Without verifiable, listing-specific case data tied to CRINONE’s exact NDA and patent set, an accurate litigation and settlement timeline cannot be produced.

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How does CRINONE compare with other progesterone products on market access and uptake?

CRINONE competes on:

• Clinical familiarity in fertility practices.
• Specialty channel access and rebate positioning.
• Tolerability and administration ease.

Comparative uptake usually tracks:

• Payer preferred status.
• Availability and shipping reliability.
• Clinic standardization protocols.

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Which companies compete for CRINONE share?

Competitors in this therapeutic class generally include:

• Sponsors of other vaginal progesterone products.
• Manufacturers of authorized generic progesterone alternatives.
• Producers of injectable progesterone and oral progesterone regimens used as substitutes depending on clinic practice.

A specific competitive roster requires exact product identifiers and market share data.

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How does regulatory pathway status influence CRINONE’s commercial outlook?

Progesterone vaginal products are typically governed by standard generic/505(j)-type frameworks where applicable, but the practical effect on CRINONE is determined by:

• Whether competitors can match the protected formulation and the approved label.
• Whether exclusivity barriers remain through patent linkage or data exclusivity periods.

Regulatory developments that improve competitor feasibility tend to accelerate price competition through channel normalization.

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What formulation and manufacturing/IP barriers protect CRINONE the most?

For CRINONE-style semi-solid vaginal gels, the most relevant barriers are often:

• Vehicle composition and release profile.
• Stability and shelf-life management.
• Unit-dose container and applicator usability.
• Manufacturing controls that ensure consistent critical quality attributes (CQAs).

If those elements are protected, competitors need detailed development work and can face delays or require design-around strategies.

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Commercial risk scenarios: what happens to CRINONE sales if a key protection falls?

Post-protection fall-through typically follows a predictable pattern in specialty branded hormones:

1. Competitor launches and secures early stocking.
2. Payer routing changes, triggering formulary and pharmacy substitution.
3. Clinic switching occurs when acquisition costs fall and tolerability is comparable.
4. Net pricing compresses faster than unit volume declines, producing revenue contraction.

Brand survival usually depends on:

• Differentiation via patient/provider preference.
• Continued favorable reimbursement.
• Limited competitive entry scope (for example, competitors that cannot fully replicate the gel or the key label).

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Key Takeaways

• CRINONE’s market is niche and protocol-driven, making sales sensitive to ART clinic prescribing patterns and payer access.
• Competitive pressure is structurally high because progesterone therapy has multiple delivery routes and units that can substitute.
• Long-run protection, where present, is likely tied to formulation, manufacturing, and method-of-use rather than to broad active-ingredient exclusivity.
• Commercial trajectory is dominated by generic/authorized-duplicate feasibility and channel contracting, not by category growth.

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FAQs

1) Does CRINONE face faster substitution than injectable progesterone in fertility clinics?

Substitution speed depends on clinic protocol standardization and payer preferred status; vaginal gels often face quicker routing changes because pharmacists can more readily switch once covered.

2) Are progesterone vaginal gels viewed as interchangeable by payers?

Payers often treat products as therapeutically substitutable but route coverage through product-NDC preference lists, creating different out-of-pocket costs and utilization.

3) What drives higher CRINONE reimbursement: brand status or product form?

Brand status can help short term, but long-run reimbursement hinges on formulary tier placement and step therapy rules.

4) What common manufacturing risks can affect supply for vaginal progesterone gels?

Semi-solids can face fill-finish lot variability, container compatibility issues, stability constraints, and distribution holds that disrupt continuous clinic replenishment.

5) How do settlement agreements typically affect generic launch timing for progesterone brands?

Settlements usually set a calendar-based launch date and define design-around or labeling constraints, shifting the start of price pressure to the agreed launch window.

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References

1. [No citations available from the provided information.]