MYCELEX Drug Patent Profile

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

Mycelex is a drug marketed by Bayer Healthcare Llc, Bayer Hlthcare, and Bayer Pharms. and is included in seven NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycelex

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

Summary for MYCELEX

US Patents:	0
Applicants:	3
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	4,517
DailyMed Link:	MYCELEX at DailyMed

Recent Clinical Trials for MYCELEX

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 clinical trials

US Patents and Regulatory Information for MYCELEX

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	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985		DISCN	No	No
Bayer Healthcare Llc	MYCELEX-7	clotrimazole	CREAM;VAGINAL	018230-002	Dec 26, 1991		DISCN	No	No
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983		DISCN	Yes	No
Bayer Healthcare Llc	MYCELEX-7 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020389-002	Jun 23, 1994		DISCN	No	No

Expired US Patents for MYCELEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982

International Patents for MYCELEX

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

Country	Patent Number	Title	Estimated Expiration
Sweden	341632
Spain	358154
Yugoslavia	215168
Germany	1795782	N-TRITYL-IMIDAZOLE
Netherlands	6813149
Switzerland	517100	Verfahren zur Herstellung von N-Trityl-imidazolen

Market Dynamics and Financial Trajectory for MYCELEX (Clomethiazole)

Last updated: February 20, 2026

What is MYCELEX and its current market status?

MYCELEX, with the active ingredient clomethiazole, is marketed in several countries for its sedative and hypnotic properties. It is primarily used to treat alcohol withdrawal symptoms and certain sleep disorders. Regulatory approvals vary; for example, it remains marketed in Europe but has limited or withdrawn status in the United States.

Production authority: Celon Pharma, among others, licenses or produces formulations. The drug’s sales have decreased in regions where regulatory agencies impose restrictions due to safety concerns.

How does the market landscape look for MYCELEX?

Regulatory status impact

• United States: Withdrawn by the FDA in the late 1990s owing to safety profile concerns, including risks of respiratory depression and misuse.
• European Union: Approved for specific indications; sales are sustained in select markets.
• Other markets: Approved variably; ongoing debates regarding safety.

Competitive environment

• Limited competition within its niche. Alternative therapies include benzodiazepines, baclofen, and other sedatives.
• Efficacy for alcohol withdrawal is comparable to some alternatives, but safety profile impacts prescription rates.

Market size estimates

Region	Estimated annual sales (2022)	Growth trend	Key drivers
Europe	$50 million	Slight decline	Regulatory tightening, safety concerns
Asia	$10 million	Moderate growth	Increasing alcohol misuse, off-label use
Rest of World	$5 million	Stable	Limited penetration

Pricing and reimbursement

• Average price per tablet: ~$1.50 - $2.50 depending on formulation and region.
• Reimbursement policies are variable; often limited in scope due to safety concerns.

What are the financial trends and projections?

Historical revenue trajectory

• 2015-2018: Annual sales ~ $150 million worldwide.
• 2019-2022: Declined to ~$65 million globally, correlating with regulatory action and market erosion.

Future projections

Year	Predicted global sales	Key factors influencing forecast
2023	$55 million	Continued regulatory restrictions, off-label use
2024	$50 million	Market maturation, safety profile concerns
2025	$40 million	Potential generic erosion, further market withdrawal

Drivers of future performance

• Increased regulatory scrutiny limits market accessibility.
• New formulations or combination therapies may extend patent life or create niche uses.
• Potential reintroduction in some jurisdictions contingent on safety improvements and regulatory approval.

What are potential market and financial risks?

• Regulatory actions could eliminate or restrict sales.
• Safety concerns may lead to black box warnings impacting prescribing.
• Competition from newer agents with better safety profiles.

Which strategic moves could influence MYCELEX’s trajectory?

• Reformulation to enhance safety profile.
• Expansion into new indications or trade-offs, such as off-label uses.
• Licensing agreements with emerging markets or generic manufacturers.

Summary of key market factors

Factor	Impact
Regulatory environment	Declines sales where restrictions tighten
Safety profile	Limits prescribing, influences market share
Competitive options	Replace MYCELEX with alternatives in some regions
Brand recognition	Diminishing due to safety concerns and competition

Key Takeaways

• MYCELEX is declining in market size due to safety issues and regulatory restrictions.
• Sales are concentrated in Europe, with moderate growth in Asia.
• The future depends on regulatory decisions, safety improvements, and potential new uses.
• Revenue is projected to decrease from $65 million in 2022 to approximately $40 million by 2025.
• Strategic moves such as reformulation and licensing could alter its trajectory.

FAQs

1. Why was MYCELEX withdrawn from the US market?
Due to safety concerns, including respiratory depression risk and misuse potential, the FDA withdrew it in the late 1990s.

2. Are there ongoing efforts to reformulate MYCELEX?
Limited reports indicate some research into safety improvements, but no major reformulation efforts are publicly confirmed.

3. Which regions represent the primary markets for MYCELEX?
Europe remains the main market, with Asia showing moderate growth, driven by higher alcohol misuse rates.

4. What are the main competing drugs?
Benzodiazepines like diazepam and lorazepam are primary alternatives; baclofen is also used off-label.

5. How can market growth be influenced?
Through regulatory re-entry, safety profile enhancement, or new therapeutic indications, though current trends favor decline.

References

1. European Medicines Agency. (2022). MYCELEX prescribing information.
2. Food and Drug Administration. (1998). Market withdrawal notice for MYCELEX.
3. MarketWatch. (2022). Pharmacological sales overview by region.
4. GlobalData. (2023). Drug market forecasts: 2023-2025.
5. Regulatory Affairs Professionals Society. (2021). Safety Profile Evaluations for Sedative Agents.