VAGISTAT-1 Drug Patent Profile

When do Vagistat-1 patents expire, and when can generic versions of Vagistat-1 launch?

Vagistat-1 is a drug marketed by Combe and is included in one NDA.

The generic ingredient in VAGISTAT-1 is tioconazole. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the tioconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vagistat-1

A generic version of VAGISTAT-1 was approved as tioconazole by PERRIGO on November 21^st, 2001.

Summary for VAGISTAT-1

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	77
Patent Applications:	5,782
DailyMed Link:	VAGISTAT-1 at DailyMed

US Patents and Regulatory Information for VAGISTAT-1

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Combe	VAGISTAT-1	tioconazole	OINTMENT;VAGINAL	020676-001	Feb 11, 1997		OTC	Yes	Yes

VAGISTAT-1 Market Dynamics, Competitive Position, and Financial Trajectory

Last updated: July 31, 2026

VAGISTAT-1 is an over-the-counter, single-dose vaginal antifungal containing tioconazole 6.5%. Its commercial position depends on convenience, retail distribution, price, and brand recognition rather than exclusivity. The product operates in a mature category with generic and private-label competition, limited switching costs, and no apparent prescription-drug patent barrier. Public filings do not report standalone VAGISTAT-1 revenue, so its financial trajectory is best assessed through category structure, product positioning, ownership, pricing, and channel economics.

What is VAGISTAT-1 and how does it work?

VAGISTAT-1 is a vaginal ointment for treating vulvovaginal candidiasis, commonly called a vaginal yeast infection. Its active ingredient is tioconazole at a 6.5% concentration. The product is administered as a single vaginal dose, which differentiates it from three-day and seven-day antifungal regimens. The FDA OTC labeling directs consumers to use the product for symptoms associated with vaginal yeast infection and to seek medical advice when symptoms recur or do not improve. [1]

Tioconazole is an imidazole antifungal. It inhibits fungal sterol synthesis and disrupts the fungal cell membrane. The product is intended for uncomplicated vaginal yeast infections and is not a broad treatment for all causes of vaginal irritation, discharge, or pain.

VAGISTAT-1 product profile

Attribute	VAGISTAT-1
Active ingredient	Tioconazole
Strength	6.5%
Dosage form	Vaginal ointment
Administration	Single dose
Regulatory status	OTC
Therapeutic category	Vaginal antifungal
Primary indication	Vaginal yeast infection
Prescription requirement	No
Key commercial advantage	One-dose convenience
Principal competitors	Monistat, generic tioconazole, store-brand vaginal antifungals

What is the FDA regulatory status of VAGISTAT-1?

VAGISTAT-1 is an OTC vaginal antifungal product regulated under the FDA framework for vaginal drug products. Tioconazole 6.5% is an established OTC active ingredient and dosage strength under the FDA’s vaginal drug product monograph framework. [2]

The product does not depend on an individual prescription-drug approval to maintain its market position. Its regulatory risk is therefore tied to compliance with OTC labeling, manufacturing controls, adverse-event reporting, product quality, and FDA enforcement rather than to renewal of a prescription approval.

The FDA OTC monograph pathway reduces development and regulatory costs compared with a new prescription drug. It also lowers barriers for competing manufacturers because a company can market a compliant product without acquiring a new chemical entity or obtaining a product-specific exclusivity period.

Does VAGISTAT-1 have FDA exclusivity?

VAGISTAT-1 does not have the type of new-drug exclusivity associated with a recently approved prescription product. It is an OTC product containing an established antifungal active ingredient. Its commercial protection comes primarily from trademarks, packaging, retail placement, consumer awareness, and distribution agreements.

The product’s single-dose formulation may have historical formulation or packaging rights, but those rights would not prevent compliant competitors from selling tioconazole 6.5% products. The principal commercial protection is brand equity, not regulatory exclusivity.

What patents protect VAGISTAT-1?

VAGISTAT-1 is not generally understood to have a meaningful active-ingredient patent estate supporting its current sales. Tioconazole is an established compound, and the product is sold in an OTC category with multiple competing formulations.

No Orange Book strategy is central to the product’s market position. Orange Book listings primarily govern approved prescription and certain other FDA-approved products. An OTC monograph product is not normally protected through Orange Book-listed patents in the same manner as a branded prescription medicine. [3]

Potential intellectual-property protection may include:

• The VAGISTAT trademark.
• Product packaging and trade dress.
• Proprietary applicator or tube design.
• Manufacturing know-how.
• Supplier contracts.
• Private-label or retailer distribution arrangements.

These rights can support pricing and shelf position but are weaker barriers than composition-of-matter patents.

When does VAGISTAT-1 lose exclusivity?

VAGISTAT-1 has no identifiable future patent-expiration event that would trigger generic entry. Generic and private-label competition is already structurally permitted because the product is based on an established OTC active ingredient.

The relevant commercial timeline is therefore driven by brand performance:

Commercial factor	Effect on VAGISTAT-1
OTC monograph availability	Keeps entry barriers low
Tioconazole ingredient maturity	Limits premium pricing
Single-dose administration	Supports consumer convenience
Retailer private labels	Creates direct price competition
Advertising expenditure	Can sustain brand awareness
Drugstore shelf placement	Influences volume and margin
Consumer switching cost	Low
Patent expiry event	Not a major market driver

Which companies compete with VAGISTAT-1?

VAGISTAT-1 competes in a fragmented OTC vaginal antifungal market. The main branded competitor is Monistat, which uses miconazole in one-day, three-day, and seven-day products. Generic and private-label manufacturers compete with tioconazole, miconazole, and clotrimazole products.

VAGISTAT-1 versus Monistat

Factor	VAGISTAT-1	Monistat
Main active ingredient	Tioconazole	Miconazole
Typical consumer proposition	One-dose treatment	Broad regimen selection
Brand architecture	Focused single-dose product	Large vaginal-health franchise
Competitive strength	Convenience and familiar one-dose format	Brand recognition and product breadth
Generic exposure	High	High
Prescription conversion	Limited relevance	Limited relevance
Pricing power	Moderate to low	Moderate, depending on format

Monistat has a broader brand platform and greater ability to segment consumers by treatment duration. VAGISTAT-1’s advantage is a simple one-dose proposition. Its disadvantage is the limited ability to defend price when generic and store-brand products offer similar active ingredients.

VAGISTAT-1 versus generic tioconazole

Generic tioconazole is the closest product substitute. The clinical and regulatory similarity between branded and generic offerings makes price, availability, packaging, and retailer promotion central purchasing factors.

Pharmacy chains and mass retailers can use private-label products to capture margin and reduce dependence on branded suppliers. That dynamic can pressure VAGISTAT-1 wholesale pricing even when consumer demand remains stable.

How strong is the patent estate for VAGISTAT-1?

The patent estate is weak as a long-term financial defense. The product has several characteristics associated with low patent durability:

1. The active ingredient is established.
2. The dosage form is conventional.
3. The product is sold OTC.
4. The active ingredient is available to competing manufacturers.
5. The category includes several therapeutic substitutes.

Formulation and device patents could create narrow protection if they cover a specific vehicle, applicator, delivery system, or manufacturing process. Such patents would not necessarily prevent competitors from marketing other tioconazole products. They would also be vulnerable to design-around strategies.

Manufacturing know-how may have greater practical value than patents. Consistent production of a stable vaginal ointment, reliable fill weights, acceptable applicator performance, and control of microbial quality can reduce recalls and preserve retailer relationships. These advantages are operational rather than legally exclusive.

Are there Paragraph IV challenges to VAGISTAT-1?

Paragraph IV litigation is not the primary competitive mechanism for VAGISTAT-1. Paragraph IV challenges apply to patents listed for approved drug products in the FDA Orange Book. An OTC monograph product does not generally create the same abbreviated new drug application patent-certification pathway used for branded prescription drugs. [3]

Competition is more likely to arise through:

• Launches of compliant OTC products.
• ANDA products where a separate approved prescription product exists.
• Private-label supply agreements.
• Retailer substitution.
• Price reductions.
• Promotional campaigns.
• Formulation and packaging alternatives.

There is no major public Paragraph IV litigation narrative associated with VAGISTAT-1 comparable to branded prescription drugs with listed patents and multi-year settlement agreements.

What formulation patents protect VAGISTAT-1?

No commercially decisive formulation patent is publicly established as the basis for VAGISTAT-1’s current market position. A vaginal ointment containing tioconazole can potentially be differentiated through its excipient system, viscosity, spreadability, retention, applicator design, or packaging. Those features may improve user experience, but they do not automatically create enforceable market exclusivity.

The practical formulation issues include:

• Uniform tioconazole distribution.
• Stability over shelf life.
• Compatibility with the applicator.
• Ease of administration.
• Reduction of leakage.
• Consumer tolerance.
• Packaging integrity.
• Microbiological quality.

A competing manufacturer can often use a different excipient system or delivery device while retaining the same active ingredient and therapeutic purpose.

What is the financial trajectory for VAGISTAT-1?

VAGISTAT-1 is best characterized as a mature OTC cash-flow product rather than a growth-stage pharmaceutical asset. Its revenue trajectory is likely shaped by category stability, distribution, brand investment, and price competition.

No public audited financial series separately identifies VAGISTAT-1 revenue, gross margin, or unit volume. The product is sold within a broader consumer-health portfolio, so company filings generally do not provide product-level financial disclosure. This limits precise valuation based on reported brand sales.

Revenue drivers

The main revenue drivers are:

• Seasonal demand for vaginal antifungal products.
• Retail distribution across pharmacies, mass merchants, grocery stores, and e-commerce.
• Consumer preference for one-dose treatment.
• Brand advertising and search visibility.
• Retail promotions.
• Availability of lower-priced generic substitutes.
• Pricing and supply terms with retailers.
• Product placement near other feminine-health products.

Margin profile

OTC vaginal antifungals can have attractive gross margins because the active ingredient is mature and the formulation is not biologically complex. Net margins are reduced by:

• Retailer trade spending.
• Coupons and promotional allowances.
• Consumer advertising.
• Packaging costs.
• Distributor margins.
• Compliance and quality costs.
• Returns and inventory write-downs.
• Private-label price pressure.

A branded single-dose product may retain a retail premium over generic products, but the premium is constrained by direct substitution and low consumer switching costs.

What generic launch risks exist for VAGISTAT-1?

Generic and private-label entry risk is high in structural terms. The principal risk is not a future patent cliff. It is gradual share erosion through products that offer the same active ingredient, concentration, and treatment duration at a lower price.

A likely generic-entry pattern is:

Scenario	Commercial effect
Stable branded demand	VAGISTAT-1 retains a premium segment
Retailer private-label expansion	Shelf space and unit share decline
Aggressive generic pricing	Brand revenue and margins contract
Strong consumer advertising	Brand maintains awareness and conversion
Distribution loss	Rapid volume decline
Supply disruption	Retailers substitute competing products
E-commerce growth	Price comparison intensifies

The product is more exposed to substitution at the retailer level than to physician prescribing behavior. Retailers can shift shelf allocation quickly when a store brand offers higher margin or lower consumer pricing.

What patent litigation and settlement agreements affect VAGISTAT-1?

There is no major publicly established patent litigation or Paragraph IV settlement framework driving VAGISTAT-1’s market. Its competitive environment is principally commercial and regulatory.

Potential disputes would more likely concern:

• Trademark infringement.
• Trade dress.
• Advertising claims.
• Product labeling.
• OTC monograph compliance.
• Contract manufacturing.
• Retail distribution.
• Product quality or recall issues.

These disputes could affect sales execution but would not normally create a long period of market exclusivity.

What licensing deals and manufacturers influence VAGISTAT-1?

VAGISTAT-1’s economics may include brand ownership, contract manufacturing, wholesale distribution, and retailer supply agreements. Product-level licensing terms are not generally reported in public financial statements.

For an OTC product, manufacturing and distribution contracts can be commercially important because they determine:

• Cost of goods.
• Minimum production volumes.
• Geographic availability.
• Retailer service levels.
• Inventory ownership.
• Recall allocation.
• Gross-to-net deductions.
• Ability to respond to demand spikes.

A change in manufacturer or distributor can affect availability and retailer confidence even when the underlying product has stable consumer demand.

What geographic markets does VAGISTAT-1 cover?

VAGISTAT-1 is primarily associated with the U.S. OTC vaginal antifungal market. Geographic expansion is constrained by country-specific rules for vaginal antifungals, labeling, claims, and product registration. A U.S. OTC monograph position does not automatically confer authorization in Canada, Europe, or other markets.

International expansion would require separate assessment of:

• Local OTC or prescription classification.
• Active-ingredient monographs.
• Product claims.
• Language requirements.
• Pharmacovigilance.
• Importation and manufacturing controls.
• Local retail access.
• Reimbursement and pharmacy practices.

The U.S. market remains the most relevant commercial jurisdiction for the brand.

What generic launch scenarios should investors monitor?

Investors and commercial partners should monitor five indicators:

1. Retailer assortment changes. Reduced facings or discontinuation at major chains can precede revenue decline.
2. Price gaps. A widening gap between VAGISTAT-1 and store-brand tioconazole can accelerate substitution.
3. Search and advertising activity. Lower brand visibility can weaken direct-to-consumer demand.
4. Stock availability. Out-of-stocks can permanently shift consumers to alternatives.
5. New delivery formats. Competitors may use applicator or packaging improvements to compete for the convenience segment.

A stable unit market can still produce declining brand revenue if the product loses share to lower-priced alternatives. Conversely, a mature category can produce durable cash flow when the brand maintains distribution and avoids supply disruption.

Key Takeaways

• VAGISTAT-1 is a single-dose OTC vaginal antifungal containing tioconazole 6.5%.
• Its principal advantage is convenience, not patent protection.
• The product faces direct competition from Monistat, generic tioconazole, miconazole, clotrimazole, and private-label products.
• No major Orange Book, Paragraph IV, or patent-expiration event is central to its commercial outlook.
• Formulation, packaging, manufacturing, trademark, and distribution rights may provide narrow protection but do not create strong market exclusivity.
• Standalone revenue and profitability are not publicly reported.
• The financial profile is that of a mature consumer-health brand exposed to retailer bargaining power, private-label substitution, promotional spending, and distribution quality.
• The most important risks are share erosion, price compression, loss of shelf space, and supply disruption.

FAQs

Is VAGISTAT-1 the same as Monistat?

No. VAGISTAT-1 contains tioconazole, while most Monistat products contain miconazole. Both are OTC vaginal antifungals, but they use different active ingredients and treatment formats.

Is VAGISTAT-1 available as a generic?

Tioconazole 6.5% products can be marketed by competing manufacturers under the applicable OTC regulatory framework. Store-brand and generic competition is therefore a central risk to the branded product.

Does VAGISTAT-1 have an Orange Book patent?

VAGISTAT-1 is an OTC monograph product, and its commercial position is not generally based on Orange Book-listed patents. Its protection is primarily branding, distribution, packaging, and manufacturing execution.

Can VAGISTAT-1 be sold outside the United States?

A U.S. OTC status does not automatically authorize sales in other countries. Each market applies its own rules for classification, labeling, manufacturing, and product registration.

What would most increase VAGISTAT-1 revenue?

Revenue would most likely increase through expanded retail distribution, stronger advertising, improved availability, premium positioning for one-dose convenience, and successful defense against private-label substitution.

References

1. U.S. National Library of Medicine. (n.d.). VAGISTAT-1- tioconazole ointment drug label. DailyMed. https://dailymed.nlm.nih.gov/dailymed/

2. U.S. Food and Drug Administration. (n.d.). OTC Monograph M005: Vaginal Drug Products for Over-the-Counter Human Use. https://www.accessdata.fda.gov/

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm