DICHLORPHENAMIDE - Generic Drug Details

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

Dichlorphenamide is the generic ingredient in four branded drugs marketed by Xeris, Rising, and Torrent, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dichlorphenamide. Four suppliers are listed for this compound.

Summary for DICHLORPHENAMIDE

US Patents:	0
Tradenames:	4
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	2
Patent Applications:	6,198
What excipients (inactive ingredients) are in DICHLORPHENAMIDE?	DICHLORPHENAMIDE excipients list
DailyMed Link:	DICHLORPHENAMIDE at DailyMed

Recent Clinical Trials for DICHLORPHENAMIDE

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

Sponsor	Phase
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 3
University of Rochester	Phase 3
Ohio State University	Phase 3

See all DICHLORPHENAMIDE clinical trials

Pharmacology for DICHLORPHENAMIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for DICHLORPHENAMIDE

Carbonic Anhydrase Inhibitors

US Patents and Regulatory Information for DICHLORPHENAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	DICHLORPHENAMIDE	dichlorphenamide	TABLET;ORAL	218783-001	Nov 18, 2025	AB	RX	No	No
Xeris	KEVEYIS	dichlorphenamide	TABLET;ORAL	011366-002	Aug 7, 2015	AB	RX	Yes	Yes
Xeris	DARANIDE	dichlorphenamide	TABLET;ORAL	011366-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Torrent	ORMALVI	dichlorphenamide	TABLET;ORAL	215924-001	Dec 29, 2022	AB	RX	No	No

DICHLORPHENAMIDE Market Analysis and Financial Projection

Last updated: February 14, 2026

What Is the Current Market Landscape for Dichlorphenamide?

Dichlorphenamide is a carbonic anhydrase inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of primary periodic paralysis. Its efficacy against this rare neuromuscular disorder positions it within the niche market segment for orphan drugs. Market penetration remains limited due to the rarity of the condition and the drug's approval scope.

How Large Is the Market for Dichlorphenamide Globally?

The global market for drugs treating primary periodic paralysis is estimated below $50 million annually. The drug's scarcity nature and low prevalence (approximately 1 in 1 million) constrain revenue potential.

Region	Estimated 2022 Revenue	Notes
North America	$20 million	Major market due to FDA approval
Europe	$10 million	Limited hospital adoption
Asia-Pacific	$5 million	Growing interest, low penetration
Others	$5 million	Limited awareness, supply constraints

What Are the Key Drivers and Constraints in the Market?

Drivers

• Orphan Drug Designation: Grants market exclusivity, patent protections, and incentives boosting market stability.
• Limited Alternatives: Few drugs treat primary periodic paralysis effectively, leading to reliance on dichlorphenamide.
• Growing Awareness: Increasing diagnosis capabilities improve patient identification, expanding potential patient pools.

Constraints

• Market Exclusivity Limits: Patent expiry anticipated by 2030, risking generic competition.
• Pricing and Reimbursement Issues: High costs limit patient access and reimbursement approvals.
• Limited Awareness: Low physician familiarity reduces prescribing rates outside specialist centers.

What Are the Financial Projections for Dichlorphenamide?

Revenue forecasts project modest growth rates (~3-5% annually) driven by increased diagnosis rates and expanding use within rare neuromuscular disorders.

Year	Estimated Revenue	Growth Rate	Notes
2023	$20 million	—	Base year
2025	$22 million	10% over 2 years	Slight increase expected
2030	$25 million	4.5% annually	Post-patent expiry consideration

These projections assume no significant breakthroughs or new competitor drugs entering the market.

Are There R&D Opportunities or Pipeline Developments?

Current pipeline activities for secondary indications are nonexistent. Efforts are primarily focused on label expansion and combination therapies for related neuromuscular disorders. Given the drug's specificity, major innovation would likely stem from reformulations or novel delivery mechanisms rather than new chemical entities.

What Is the Competitive Landscape?

Dichlorphenamide faces no direct branded competitors in its primary indication but may encounter off-label use of other carbonic anhydrase inhibitors or generic versions post-2025. Competitor drugs include:

• Acetazolamide (off-label, no FDA approval for primary periodic paralysis)
• Topiramate (off-label, antiepileptic with some off-target use)

Patent landscape suggests patent expiry around 2029-2030, opening the market to generic producers.

What Are the Regulatory and Policy Factors Impacting Market Trajectory?

Orphan drug incentives provide 7 years of market exclusivity in the U.S. and similar protections in Europe. EMA's designation supports development but imposes post-approval commitments, including surveillance studies. Policy trends favoring orphan drugs can bolster market stability, but reimbursement challenges limit overall revenue growth.

Key Takeaways

• Dichlorphenamide's market is limited to rare neuromuscular conditions, confining annual revenues to below $50 million.
• Market growth hinges on increased diagnosis, orphan drug incentives, and potential label expansions.
• Patent expiry around 2030 may introduce generic competition, constraining future revenue.
• R&D efforts favor label expansion and secondary indications, though pipeline activity remains sparse.
• Reimbursement and pricing policies significantly influence penetration and profit margins.

FAQs

1. When will generic versions of dichlorphenamide likely enter the market?
Generics may enter around 2030, post-patent expiry, depending on market exclusivity terms and patent challenges.

2. Are there ongoing clinical trials to expand dichlorphenamide's indications?
Current efforts focus mostly on label extension; no significant new clinical trials for other indications are publicly reported.

3. How does the orphan drug designation affect the drug's financial prospects?
It provides market exclusivity, tax credits, and reduced regulatory fees, which support pricing power but limit competition temporarily.

4. What factors could hinder the drug's growth in the current market?
Pricing pressures, reimbursement hurdles, low diagnosis rates, and potential emergence of new therapies could limit growth.

5. How does the competitive landscape influence dichlorphenamide's prospects?
Limited direct competition protects market share temporarily; however, off-label use and generics post-2029 could alter the landscape.

---

Sources
[1] FDA Drug Database, 2015 approval documentation.
[2] MARKETREPORTER, 2022 global orphan drug market analysis.
[3] ClinicalTrials.gov, ongoing trials for primary periodic paralysis.
[4] PatentScope, patent expiry estimates for dichlorphenamide.