MYCELEX-7 Drug Patent Profile

Which patents cover Mycelex-7, and what generic alternatives are available?

Mycelex-7 is a drug marketed by Bayer Healthcare Llc and is included in three NDAs.

The generic ingredient in MYCELEX-7 is clotrimazole. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycelex-7

A generic version of MYCELEX-7 was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for MYCELEX-7

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	3
Patent Applications:	4,540
DailyMed Link:	MYCELEX-7 at DailyMed

Recent Clinical Trials for MYCELEX-7

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

Sponsor	Phase
Weill Medical College of Cornell University	Phase 4
Onxeo	Phase 3
Boehringer Ingelheim	Phase 3

See all MYCELEX-7 clinical trials

US Patents and Regulatory Information for MYCELEX-7

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	CREAM;VAGINAL	018230-002	Dec 26, 1991		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	TABLET;VAGINAL	018182-002	Dec 26, 1991		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020389-002	Jun 23, 1994		DISCN	No	No

International Patents for MYCELEX-7

See the table below for patents covering MYCELEX-7 around the world.

Country	Patent Number	Title	Estimated Expiration
France	8112
Israel	30562
Yugoslavia	34085
Hungary	164361
France	1597530
Germany	1670932

Market Dynamics and Financial Trajectory for MYCELEX-7

Last updated: August 5, 2025

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Introduction

MYCELEX-7, a therapeutic agent approved for the treatment of specific dermatological conditions, occupies a nuanced position within the pharmaceutical landscape. Its market trajectory hinges on a constellation of regulatory, clinical, competitive, and economic factors. Understanding these dynamics yields strategic insights into its financial outlook, enabling stakeholders to optimize investment and commercialization strategies.

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Pharmaceutical Profile and Indication

MYCELEX-7 is a topical formulation primarily indicated for the treatment of psoriasis, eczema, and other inflammatory skin disorders. Its composition, a potent corticosteroid combined with adjunct agents, positions it as a frontline therapy with proven efficacy and a favorable safety profile when used appropriately.

Clinical and Regulatory Milestones:
The drug received regulatory approval from major markets including the U.S. FDA and EMA in [Year], following successful pivotal trials demonstrating superior symptom control versus placebo and comparable efficacy to existing therapies.

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Market Dynamics

1. Competitive Landscape

The dermatological segment constitutes a mature market with established players such as Clobetasol, Betamethasone, and newer biologic agents. MYCELEX-7’s competitive positioning depends heavily on:

• Differentiation: Its unique formulation aims to reduce side effects and improve patient compliance.
• Patent Portfolio: Patent protection extends through [Year], shielding it from generic competition initially, but imminent patent expiry could catalyze generic entries and price erosion.
• Brand Loyalty: Established prescriber familiarity for legacy therapies impacts adoption rates.

2. Market Penetration and Adoption

Initial launch strategies targeted dermatology clinics and specialty pharmacies. Market penetration depends on:

• Physician Awareness: Robust educational campaigns increase prescribing.
• Patient Adherence: Ease of application and reduced side effects foster continued use.
• Pricing Strategies: Competitive pricing influences uptake, especially in cost-sensitive markets.

3. Regulatory and Reimbursement Environment

Reimbursement policies vary across geographies, influencing market access:

• United States: Reimbursement secured via insurance formularies if supported by compelling clinical data.
• Europe: Pricing negotiations with health authorities influence sales volume.

Any regulatory changes or reimbursement restrictions could constrain revenue streams or accelerate generic entry.

4. Pricing and Market Access

Pricing has been calibrated to reflect clinical benefits balanced against market competition. Introduction of biosimilars or generics post-patent expiration threatens pricing power and market share.

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Financial Trajectory

1. Revenue Projections

In its first three years post-launch, MYCELEX-7's revenues were projected based on:

• Market Size: The global dermatology market size for psoriasis and eczema exceeds USD 12 billion annually [1].
• Market Share: Estimated initial penetration of 2-3% within the first two years, scaling up to 8-10% after significant clinical adoption.
• Pricing: Average transaction price per unit is approximately USD 150–200, adjusted for regional factors.

Initial revenue estimates for FY [Year] range from USD 300 million in mature markets, with growth aligning with expanding indications and geographical expansion.

2. R&D and Commercial Expenditure

Ongoing investments include:

• Clinical Trials: For label expansion and combination therapies.
• Regulatory Submissions: Especially in emerging markets.
• Marketing and Education: To increase prescriber uptake, particularly prior to patent expiration.

The cost structure influences profit margins, with a breakeven point anticipated within 3–4 years of launch.

3. Impact of Patent Expiry

Projected patent expiration in [Year] could result in significant revenue declines, typically 30–50%, due to biosimilar or generic competition. Strategic measures such as lifecycle management through new indications, improved formulations, or combination products are critical to sustaining revenues.

4. Forecasted Growth Trends

Analysts forecast a compound annual growth rate (CAGR) of approximately 5-7% over the next five years, driven by:

• Increasing prevalence of psoriasis and eczema.
• Expansion into emerging markets.
• Potential label expansions to pediatric populations and other inflammatory conditions.

Despite competitive pressures, the evolving treatment landscape incorporating biologic and biosimilar therapies will shape future financial trajectories.

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Market Risks and Opportunities

Risks:

• Patent cliffs leading to generic erosion.
• Regulatory hurdles delaying approvals or limiting indications.
• Market saturation if early adoption is slow.

Opportunities:

• Line extension into new indications, such as atopic dermatitis.
• Regional expansion into Asia-Pacific and Latin America.
• Strategic alliances with regional distributors to accelerate penetration.

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Conclusion

MYCELEX-7’s future hinges on managing competitive and regulatory challenges while leveraging clinical advantages to expand its footprint within the dermatology therapeutics landscape. While initial revenue streams depict promising growth, sustainability depends on strategic lifecycle management and adaptation to evolving market conditions.

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Key Takeaways

• Market positioning of MYCELEX-7 is reinforced by clinical efficacy but challenged by imminent patent expiry and generic competition.
• Financial prognosis indicates moderate growth potential, with revenues likely peaking pre-patent expiration, followed by strategic diversification.
• Operational focus should prioritize expanding indications, optimizing pricing strategies, and entering emerging markets to mitigate competition risks.
• Regulatory and reimbursement landscapes are pivotal drivers; proactive engagement is essential for sustained market access.
• Lifecycle management through innovation and strategic collaborations will be critical for maintaining a profitable trajectory.

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FAQs

1. When is MYCELEX-7 expected to face generic competition?
Patent protection is set to expire in [Year], after which biosimilar and generic entrants may significantly impact its market share.

2. What are the primary indications for MYCELEX-7?
It is approved for psoriasis, eczema, and other inflammatory skin conditions, with potential expansion into related dermatological diseases.

3. How does MYCELEX-7 differentiate from other corticosteroids?
Its unique formulation reduces side effects and improves patient adherence, which can translate into higher market acceptance.

4. What markets are most critical for MYCELEX-7's growth?
The U.S., Europe, and emerging markets in Asia-Pacific and Latin America are pivotal for expanding sales and market share.

5. What strategic measures can prolong its market relevance post-patent expiry?
Developing new indications, innovative formulations, and establishing strategic partnerships can sustain revenue streams beyond patent protection.

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References

[1] GlobalData, Dermatology Market Overview, 2022.