GYNAZOLE-1 Drug Patent Profile

Which patents cover Gynazole-1, and when can generic versions of Gynazole-1 launch?

Gynazole-1 is a drug marketed by Padagis Israel and is included in one NDA.

The generic ingredient in GYNAZOLE-1 is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for GYNAZOLE-1

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,276
DailyMed Link:	GYNAZOLE-1 at DailyMed

Recent Clinical Trials for GYNAZOLE-1

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

Sponsor	Phase
Perrigo Company	N/A
Padagis LLC	N/A

See all GYNAZOLE-1 clinical trials

Pharmacology for GYNAZOLE-1

Drug Class

Azole Antifungal

US Patents and Regulatory Information for GYNAZOLE-1

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923-001	May 18, 2012		RX	No	Yes

Gynazole-1 Market Dynamics and Financial Trajectory

Last updated: August 10, 2026

Gynazole-1 is a mature, single-dose vaginal antifungal containing butoconazole nitrate 2%. Its commercial value has been constrained by generic competition, low clinical differentiation, over-the-counter alternatives and the absence of meaningful remaining regulatory exclusivity. Public sources do not disclose product-level revenue, but the available market evidence supports a mature-to-declining financial trajectory rather than a growth product.

What is Gynazole-1 and how does it work?

Gynazole-1 is a prescription vaginal cream indicated for vulvovaginal candidiasis, commonly called vaginal yeast infection. The product uses butoconazole nitrate, an imidazole antifungal that inhibits fungal sterol synthesis and damages the fungal cell membrane.

Attribute	Gynazole-1
Active ingredient	Butoconazole nitrate
Strength	2% vaginal cream
Dosage form	Single-dose prefilled vaginal applicator
FDA product	NDA 020598
Therapeutic class	Vaginal antifungal
Primary indication	Vulvovaginal candidiasis
Administration	One full applicator, generally at bedtime
Approval period	Mid-1990s
Regulatory status	Mature prescription product with expired original exclusivity

The single-dose regimen was the product’s principal commercial differentiator. Competing vaginal antifungals often require one, three or seven days of treatment, while oral fluconazole offers a different route of administration.

What is the FDA and Orange Book status of Gynazole-1?

Gynazole-1 was approved through a conventional new drug application rather than a biologics pathway. Its original FDA approval and any associated clinical exclusivity periods expired decades ago. The product is therefore exposed to abbreviated new drug application competition.

The FDA Orange Book is the principal source for determining whether a brand product has listed patents or regulatory exclusivity that could delay generic approval. For a mature butoconazole product such as Gynazole-1, the commercial question is less about remaining exclusivity and more about whether a generic manufacturer has the manufacturing capability, bioequivalence package and commercial incentive to maintain supply.

The practical regulatory position is:

Regulatory factor	Commercial implication
Original approval	Long expired
New chemical entity exclusivity	Expired
Pediatric exclusivity	No known material remaining effect
Orange Book patent protection	No meaningful late-life barrier is generally associated with the product
Generic pathway	ANDA pathway is available
Biosimilar pathway	Not applicable
Current market risk	Generic substitution and supply economics

FDA labeling establishes the product’s indication, dosing, warnings and clinical profile. The Orange Book determines listed patent and exclusivity status, but it does not capture every manufacturing, trademark, formulation or trade-secret issue.[1][2]

When does Gynazole-1 lose exclusivity?

Gynazole-1 lost meaningful market exclusivity years ago. Butoconazole is an established active pharmaceutical ingredient, and the product is not protected by the type of regulatory exclusivity that supports premium pricing for newer antifungals.

The relevant timeline is:

Period	Event and market effect
1990s	FDA approval of Gynazole-1 for vulvovaginal candidiasis
Late 1990s to early 2000s	Brand-led commercialization and physician awareness
2000s	Erosion of original product protection and increased generic feasibility
2010s	Greater pressure from generic vaginal antifungals and low-cost OTC products
2020s	Mature category economics, limited differentiation and uncertain brand availability

Any patent protection covering the original butoconazole molecule or basic cream formulation would have expired before the current commercial period. Later formulation or manufacturing patents, if any existed, would not necessarily block generic entry unless they were listed and enforceable against the marketed product.

What patents protect Gynazole-1?

Gynazole-1 does not appear to have a commercially meaningful active patent estate comparable with newer branded pharmaceuticals. The original compound and core vaginal cream concepts are old technologies. Patent claims relating to the active ingredient, basic delivery vehicle or conventional antifungal use would generally have reached the end of their statutory terms.

The likely IP position is:

IP category	Assessment
Active ingredient patent	Expired or commercially irrelevant
Basic vaginal cream formulation	Expired or readily design-around
Single-dose applicator	Limited barrier unless protected by a separate enforceable patent
Method-of-use patents	No known late-life exclusivity with material market effect
Manufacturing know-how	Potential operational advantage, not a substitute for patent exclusivity
Trademark	May protect branding but does not block generic approval

A branded manufacturer could still retain value through trademark recognition, supplier relationships, packaging, distribution and physician familiarity. Those protections are weaker than patent exclusivity and normally do not support sustained premium pricing once therapeutically substitutable products are available.

How many patents cover Gynazole-1?

No meaningful active patent portfolio is generally associated with Gynazole-1 in the mature U.S. market. The product’s competitive position is therefore determined by regulatory approval, supply reliability and commercial execution rather than patent density.

Patent litigation and Paragraph IV activity have not been major visible drivers of the product’s recent market profile. The absence of a high-profile patent dispute is consistent with an old active ingredient, a low-value market and limited economic incentive to litigate.

Are there Paragraph IV challenges to Gynazole-1?

A Paragraph IV challenge is used when an ANDA applicant certifies that a listed brand patent is invalid, unenforceable or not infringed. Gynazole-1 has limited apparent exposure to this mechanism because its principal exclusivity period has expired and the product does not have a prominent late-life patent estate.

For commercial purposes, generic competition can arise without a major Paragraph IV dispute. An ANDA applicant may rely on a Paragraph III certification, a statement that no relevant patent is listed, or a regulatory pathway that does not require an active patent challenge.

The competitive risk is therefore ordinary generic entry, not a headline patent cliff.

What formulations are protected by Gynazole-1?

The marketed formulation is a 2% butoconazole nitrate vaginal cream delivered through a single-use applicator. The formulation’s value comes from patient convenience and local administration rather than advanced drug-delivery technology.

Potential formulation advantages include:

• One-dose treatment.
• Direct vaginal delivery.
• Reduced dependence on patient adherence over multiple nights.
• Established clinical use and physician familiarity.

These advantages do not create a strong barrier to competition. A generic manufacturer can seek approval for a therapeutically equivalent cream and may compete on price even if its packaging, excipients or applicator design differs.

The main technical barriers are manufacturing consistency, microbiological quality, preservative performance, emulsion stability, applicator filling and accurate dose delivery. These are real execution requirements, but they are typical pharmaceutical manufacturing challenges rather than durable IP barriers.

What generic entry risks exist for Gynazole-1?

Generic entry risk is high. The category contains several substitutes that can displace Gynazole-1:

Competitor	Ingredient	Route or regimen	Competitive effect
Generic butoconazole	Butoconazole nitrate	Vaginal cream	Direct substitution
Monistat	Miconazole	OTC vaginal products	Price and access pressure
Terconazole generics	Terconazole	Vaginal cream or suppository	Prescription alternative
Generic fluconazole	Fluconazole	Oral dose	Convenience and low cost
Brexafemme	Ibrexafungerp	Oral prescription	Newer branded alternative
Vivjoa	Oteseconazole	Oral prescription	Recurrent infection segment

Direct generic competition is the highest risk because it can replicate the same active ingredient and route. OTC miconazole products pressure the entire prescription vaginal-antifungal category by offering immediate pharmacy access and low prices.

Generic substitution is moderated by several factors. Some patients and clinicians prefer a single-dose product, some patients cannot use oral therapy, and payer formularies may not automatically substitute among different active ingredients. Those factors can preserve residual demand but do not restore exclusivity.

How does Gynazole-1 compare with competing antifungals?

Gynazole-1 occupies a narrow convenience segment.

Product type	Main advantage	Main weakness relative to Gynazole-1
Gynazole-1	Single-dose local treatment	Limited differentiation and generic exposure
Miconazole OTC	Low price and broad consumer awareness	Multi-day regimens are common
Terconazole	Prescription efficacy and multiple dosage forms	Less distinctive and genericized
Fluconazole	Oral administration and convenience	Drug interactions, contraindications and systemic exposure
Ibrexafungerp	New mechanism and oral treatment	Higher price and newer-market adoption requirements
Oteseconazole	Recurrent VVC prevention	Narrower indication and different patient population

Gynazole-1 is most vulnerable in uncomplicated infections where price and access dominate. Its relative position is stronger for patients seeking one-dose local treatment or avoiding systemic drug exposure.

What is the financial trajectory for Gynazole-1?

Public company filings do not generally report Gynazole-1 revenue as a separate product line. The product has been associated with private-label, specialty and portfolio-based commercialization structures, which limits direct revenue visibility.

The likely trajectory is:

1. Initial adoption: Revenue was supported by product novelty, prescription positioning and the single-dose regimen.
2. Maturity: Sales stabilized as the product became part of a broad vaginal-antifungal category.
3. Erosion: Generic products, OTC alternatives and payer pressure reduced pricing power.
4. Late life: Revenue became dependent on distribution, supply continuity and residual brand preference.
5. Current economics: The product is more likely to generate low-margin mature-product revenue than meaningful growth.

A simplified commercial model is:

Revenue driver	Direction
Unit demand	Flat to declining
Net price	Declining under generic and payer pressure
Gross margin	Vulnerable to low-volume manufacturing
Marketing expense	Likely reduced because the category is mature
Brand equity	Residual but limited
Revenue visibility	Low because product-level disclosure is limited
Growth opportunity	Narrow without new formulation or channel strategy

The product can remain commercially viable at modest scale if manufacturing costs are low, supply is reliable and distribution is concentrated in profitable channels. A single-dose product may also command a price premium over multi-dose generic creams, but that premium is constrained by therapeutic substitution.

Which companies are challenging Gynazole-1?

The main competitive threat comes from manufacturers of generic butoconazole, terconazole, miconazole and fluconazole rather than from a single branded challenger. Generic manufacturers typically compete through pharmacy benefit managers, wholesalers, retail pharmacies and contract distribution.

The most important competitive variables are:

• ANDA approval and product availability.
• Wholesale acquisition cost.
• Reimbursement tier placement.
• Ability to maintain uninterrupted supply.
• Applicator and packaging reliability.
• Retail and mail-order distribution.
• Manufacturer reputation with wholesalers and pharmacies.

No major public litigation campaign or settlement agreement is central to the product’s current market economics. The absence of litigation does not indicate strong protection. It reflects the age of the product and the limited value of extending a low-growth antifungal franchise through litigation.

What manufacturing and geographic barriers affect Gynazole-1?

Gynazole-1 is a conventional small-molecule dosage form. It does not face the cold-chain, cell-line, biosimilar or complex biologic manufacturing barriers associated with injectable biologics.

Manufacturing risks include:

• Consistent drug dispersion within the cream.
• Control of viscosity and emulsion stability.
• Microbial limits and preservative performance.
• Filling accuracy for the single-use applicator.
• Packaging compatibility.
• Reliable supply of butoconazole nitrate.
• FDA compliance at the manufacturing site.

Geographic protection is also limited. U.S. commercial value depends primarily on FDA approval, reimbursement and distribution. Patent rights in Europe, Canada or other markets would need separate country-level analysis. The existence of a U.S. brand does not establish equivalent protection in other jurisdictions.

What is the generic launch outlook for Gynazole-1?

A generic launch would not require a major market reconfiguration. The likely outcomes are:

Scenario	Expected effect
One reliable generic entrant	Moderate price erosion and lower brand volume
Multiple generic entrants	Significant price compression and pharmacy substitution
Brand supply interruption	Rapid migration to generic or OTC alternatives
Continued brand availability	Residual demand from preference and prescribing habits
New single-dose competitor	Further loss of convenience-based differentiation

The most realistic commercial outlook is continued erosion with intermittent residual demand. A recovery would require a new delivery format, a stronger distribution agreement, expanded indication or a materially differentiated patient-benefit profile.

Key Takeaways

• Gynazole-1 is a mature butoconazole nitrate 2% vaginal cream marketed as a single-dose treatment.
• Its original FDA exclusivity has expired, and no material late-life patent barrier is generally associated with the product.
• Generic butoconazole, terconazole, miconazole and fluconazole create substantial substitution pressure.
• OTC products limit prescription pricing power across the category.
• Product-specific revenue is not publicly reported, but the financial trajectory is consistent with mature-to-declining sales.
• The principal risks are generic substitution, low-volume manufacturing economics and supply interruption.
• Biosimilar risk is not relevant because Gynazole-1 is a conventional small-molecule drug.
• Patent litigation and settlement agreements are not major current drivers of the product’s market value.
• Residual value depends on single-dose convenience, brand familiarity, distribution and reliable supply.

FAQs

Is Gynazole-1 still commercially important?

Gynazole-1 has residual value in the single-dose vaginal-antifungal segment, but it is not positioned as a high-growth pharmaceutical asset. Its importance is limited by generic and OTC competition.

Does Gynazole-1 have orphan-drug exclusivity?

No orphan-drug exclusivity is associated with its conventional indication for vulvovaginal candidiasis.

Can a generic manufacturer copy the Gynazole-1 applicator?

A generic manufacturer can develop an equivalent single-dose vaginal delivery system, subject to FDA requirements for product performance, dose delivery, packaging and approval.

Is Gynazole-1 exposed to biosimilar competition?

No. Biosimilars apply to biological products. Gynazole-1 is a small-molecule antifungal evaluated through the drug approval and ANDA framework.

What would increase the value of the Gynazole-1 franchise?

A differentiated formulation, improved delivery system, international licensing, strong pharmacy distribution or an indication with less generic competition could improve value. The current formulation alone offers limited protection from price erosion.

References

1. U.S. Food and Drug Administration. (1995). Gynazole-1 (butoconazole nitrate) vaginal cream 2% prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database.
4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations.
5. U.S. Food and Drug Administration. (2024). Approved drug products and regulatory exclusivity provisions.