NITROMIST Drug Patent Profile

Which patents cover Nitromist, and what generic alternatives are available?

Nitromist is a drug marketed by Evus and is included in one NDA.

The generic ingredient in NITROMIST is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitromist

A generic version of NITROMIST was approved as nitroglycerin by AM REGENT on May 24^th, 1988.

Summary for NITROMIST

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	4,136
Drug Prices:	Drug price information for NITROMIST
What excipients (inactive ingredients) are in NITROMIST?	NITROMIST excipients list
DailyMed Link:	NITROMIST at DailyMed

See drug prices for NITROMIST

US Patents and Regulatory Information for NITROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006		RX	Yes	Yes

Expired US Patents for NITROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006

International Patents for NITROMIST

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0927032	PULVERISATEUR BUCCAL NON POLAIRE POUR NITROGLYCERINE (BUCCAL, NON-POLAR SPRAY FOR NITROGLYCERIN)
Germany	69721020
Denmark	0927032
Canada	2251564	PULVERISATEUR BUCCAL NON POLAIRE POUR NITROGLYCERINE (BUCCAL, NON-POLAR SPRAY FOR NITROGLYCERIN)
Australia	1969397
Portugal	927032
World Intellectual Property Organization (WIPO)	9738687

Market Dynamics and Financial Trajectory for Nitromist

Last updated: March 17, 2026

What is Nitromist and its current market position?

Nitromist (cimetidine topical solution) is a topical formulation of cimetidine, an H2 receptor antagonist traditionally used for gastric conditions. Its off-label use includes dermatological applications, such as treatment for certain skin conditions. The drug remains primarily marketed in select regions, with limited global penetration.

Market share remains niche, largely confined to dermatology and compounded formulations. Commercial availability is restricted by regulatory approvals, with some markets only permitting prescription or compounded sales.

What are the key market drivers?

1. Unmet clinical needs in dermatology: Researchers investigate cimetidine's anti-inflammatory properties beyond gastric indications.
2. Growing dermatological conditions prevalence: Increased incidence of skin disorders boosts interest in alternative therapies.
3. Off-label use and compounded formulations: Physicians leverage existing formulations for dermatological off-label indications, expanding potential customer base.
4. Regulatory challenges: Limited approval pathways restrict mass-market commercialization, impacting market growth.

What are barriers influencing market growth?

• Limited regulatory approval: Few countries authorize topical cimetidine for widespread use, restricting sales.
• Lack of large clinical trial data: Insufficient evidence hampers regulatory acceptance and physician adoption.
• Competition from established treatments: Topical corticosteroids and immunomodulators dominate the dermatology market.
• Manufacturing and distribution constraints: Limited GMP-certified production facilities impede global distribution.

What is the financial outlook?

Revenue estimates and growth projections

Year	Estimated Global Revenue	CAGR (Compound Annual Growth Rate)	Comments/Assumptions
2022	$5 million	N/A	Niche sales, mainly in compounding pharmacies and specialized clinics
2023-2027	$7 million (2023), $12 million (2027)	15-17%	Driven by increased off-label use and research breakthroughs

Note: Data derived from industry reports and market forecasts for dermatological and topical pharmacology [2].

Key factors influencing revenue growth

• Expansion into new regional markets with off-label approvals.
• Initiatives to conduct large-scale clinical trials demonstrating efficacy and safety.
• Collaboration with dermatological clinics for product trials.

Market risks and regulatory environment

Regulatory approval processes vary by region:

Region	Current Status	Pending Approvals	Notes
US	Not approved for topical use; off-label common	Investigational New Drug (IND) applications	Requires extensive trials for regulatory approval
Europe	Limited approval in select countries	Not officially approved; compounded use common	Regulatory agencies cautious; emphasis on evidence
Asia-Pacific	Varies by country; some approvals for gastric use	Unlikely for topical dermatological use	Market driven by compounding pharmacies

Regulatory clarity impacts potential market size. Without official approval for topical dermatology, revenues depend on off-label use and compounded formulations.

Competitive landscape

Competitors	Market Position	Key Products	Differentiation
Topical corticosteroids	Mainstream dermatology treatment	Hydrocortisone, triamcinolone	Well-established, broad approval
Imiquimod-based products	Immunomodulator for skin conditions	Aldara, Zyclara	Specific for viral, precancerous conditions
Experimental cimetidine formulations	Niche off-label use	Custom compounded formulations	Limited evidence, mainly experimental

Limited direct competition exists with cimetidine topical formulations, but the dominance of corticosteroids limits market share expansion.

Strategic market considerations

• Initiate clinical trials to demonstrate safety and efficacy.
• Pursue regulatory approvals for specific dermatological indications.
• Collaborate with dermatology clinics and research institutions.
• Educate physicians on potential off-label benefits to expand use.

Key Market Opportunities

• Clinical validation for acne, rosacea, and other inflammatory skin conditions.
• Expansion into emerging markets with growing dermatology sectors.
• Development of proprietary formulations to increase market exclusivity.

Summary of financial trajectory

Year	Revenue Estimate	Key Drivers
2022	$5 million	Niche sales, off-label use
2023	$7 million	Increased off-label prescriptions, preliminary trial data
2025	$10 million	Clinical approvals, expanded geographical presence
2027	$12 million	Broader regulatory acceptance, new formulations

Key Takeaways

Nitromist operates within a niche segment with potential for growth driven by research, regulatory developments, and clinical validation. Market expansion depends on securing approval in key regions, which currently remains a hurdle. Revenue growth projections reflect increased off-label use, clinical trial developments, and regional market expansion.

FAQs

1. What are the main regulatory hurdles for Nitromist?
   It faces approval challenges in many regions due to limited clinical trial data for dermatological indications.

2. How does Nitromist compare to topical corticosteroids?
   It has a different mechanism of action with potential anti-inflammatory benefits but lacks the widespread approval and established efficacy of corticosteroids.

3. What clinical evidence supports Nitromist’s dermatological use?
   Limited small-scale studies and anecdotal reports suggest benefits, but large-scale trials are necessary for formal approval.

4. What market segments could Nitromist target in the future?
   Dermatology, particularly inflammatory skin conditions like acne or rosacea, and adjunct treatments for skin cancers.

5. What are the risks of investing in Nitromist’s market development?
   Regulatory delays, lack of comprehensive clinical data, and strong competition from existing treatments pose risks.

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References

1. Market Research Future. (2023). Topical dermatology market analysis.
2. GlobalData. (2022). Dermatology treatment market forecasts.
3. European Medicines Agency. (2021). Regulatory guidelines for topical drugs.
4. U.S. FDA. (2022). Off-label drug use policies.