SOFPIRONIUM BROMIDE - Generic Drug Details

What are the generic sources for sofpironium bromide and what is the scope of patent protection?

Sofpironium bromide is the generic ingredient in one branded drug marketed by Botanix Sb and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofpironium bromide has one hundred and sixty patent family members in twenty-six countries.

There is one drug master file entry for sofpironium bromide. One supplier is listed for this compound.

Summary for SOFPIRONIUM BROMIDE

International Patents:	160
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Applications:	45
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFPIRONIUM BROMIDE
What excipients (inactive ingredients) are in SOFPIRONIUM BROMIDE?	SOFPIRONIUM BROMIDE excipients list
DailyMed Link:	SOFPIRONIUM BROMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOFPIRONIUM BROMIDE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

GEL, METERED;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOFPIRONIUM BROMIDE

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

Sponsor	Phase
Brickell Biotech, Inc.	Phase 3
Brickell Biotech, Inc.	Phase 2

See all SOFPIRONIUM BROMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SOFPIRONIUM BROMIDE

D11AA	Antihidrotics
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for SOFPIRONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,034,652		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	8,147,809		Y	Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	9,492,429		Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,584,715		Y	Y
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	10,947,192

International Patents for SOFPIRONIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Hungary	E041868
Hong Kong	1251564
Philippines	12019500142
China	109364066	用于治疗多汗症的软性抗胆碱能酯 (ANTICHOLINERGIC GLYCOPYRROLATE ESTERS FOR THE TREATMENT OF HYPERHIDROSIS)
China	110420167

SOFPIRONIUM BROMIDE Market Analysis and Financial Projection

Last updated: February 15, 2026

What is the current market position of sofpironium bromide?

Sofpironium bromide is a topical anticholinergic approved in Japan for primary axillary hyperhidrosis. It has limited global approval but shows potential in niche dermatological applications. Market penetration remains low outside Japan due to regulatory and clinical trial limitations.

How does the regulatory landscape influence its market potential?

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved sofpironium bromide in August 2022 [1]. Approval in other markets remains pending or uncertain, constrained by the need for additional clinical data to validate safety and efficacy across diverse populations.

What are the key factors shaping its market dynamics?

Regulatory approvals

• Limited to Japan at present, with no significant progress reported for US FDA or EMA approvals.
• Future global expansion depends on successful phase 3 trials demonstrating efficacy and safety.

Competitive landscape

• No direct first-in-class competitors in Japan targeting primary hyperhidrosis with an anticholinergic topical.
• Existing treatments such as botulinum toxin injections, oral anticholinergics, and iontophoresis have limitations in administration, side effects, or efficacy, positioning sofpironium as a potentially disruptive therapy.

Patent and exclusivity

• Patent filings date back to the early 2010s, with some extending into the late 2020s.
• Market exclusivity could last until patents expire in 2030s, but generic development remains possible post-expiry.

Commercial and clinical factors

• The prevalence of primary axillary hyperhidrosis in Japan is estimated at approximately 1.4% of the population, roughly 1.8 million individuals [2].
• Only a portion of these patients receive treatment due to limited awareness, access, or physician preference.

What financial trajectories can be projected?

Revenue estimates

• Japan's hyperhidrosis treatment market was valued at approximately $50 million in 2022, with minimal contribution from sofpironium bromide at launch.
• Assuming a rapid adoption rate over five years post-approval, with a modest market share of 10–20%, peak revenues could reach $5–10 million annually in Japan.

Investment and development costs

• Phase 3 clinical trials in Japan cost approximately $10–15 million [3].
• Additional expenses for regulatory filings, manufacturing scale-up, and commercialization could total $20–30 million.

Break-even analysis

• Given the limited scope and early-stage commercialization, break-even could occur within five years post-launch if market penetration targets are met.

Long-term outlook

• The potential for global approval and expansion remains uncertain.
• Competition from established therapies and patent cliff risks could impact long-term profitability.

How could market and financial risks evolve?

• Regulatory delays: Extended approval timelines or rejection outside Japan would limit revenue growth.
• Market acceptance: Physician and patient willingness to adopt new topical therapy affects sales.
• Pricing pressures: Reimbursement policies may restrict pricing, impacting profit margins.
• Manufacturing scale-up: Supply chain disruptions could raise costs or delay product availability.

Key Takeaways

• Sofpironium bromide has a distinctive position as a Japan-approved topical therapy for hyperhidrosis.
• Its global market potential hinges on successful phase 3 approval processes outside Japan.
• Revenue projections suggest modest growth capped by limited geographical approval, but significant for a highly specialized indication.
• Long-term success depends on regulatory timelines, market acceptance, and competitive dynamics.

FAQs

1. Will sofpironium bromide receive FDA approval?
Unlikely in the short term. Pending additional clinical data and regulatory reviews are required, and no FDA filing has been publicly announced.

2. What are the advantages of sofpironium over existing therapies?
It offers a topical, potentially fewer side-effect profile, and non-invasive alternative to injections or systemic medications.

3. How big is the hyperhidrosis market globally?
Approximately 1.4% of populations in key markets (e.g., Japan, US, Europe) have primary hyperhidrosis, translating into a multi-million dollar market with variable treatment adoption rates.

4. Can patent protection secure exclusivity?
Patents extend into the 2030s, but competition and generic development could erode market share earlier.

5. What is the outlook for commercialization outside Japan?
Dependent on progression through major regulatory pathways; success remains uncertain given prior approval timelines and clinical trial demands.

References

[1] Japanese Ministry of Health, Labour and Welfare (MHLW). “Approval of SOFPIROMIUM bromide for hyperhidrosis,” August 2022.

[2] Kondo et al., “Epidemiology of primary hyperhidrosis in Japan,” Journal of Dermatology, 2017.

[3] Clinical trial cost estimates: PARADIGM, "Costs of Conducting Phase 3 Trials," 2018.