You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

DICHLORPHENAMIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

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

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

Summary for DICHLORPHENAMIDE
US Patents:0
Tradenames:3
Applicants:2
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 86
Clinical Trials: 2
Patent Applications: 6,088
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

SponsorPhase
University of RochesterPhase 3
National Institute of Neurological Disorders and Stroke (NINDS)Phase 3
National Center for Research Resources (NCRR)Phase 3

See all DICHLORPHENAMIDE clinical trials

Pharmacology for DICHLORPHENAMIDE
Medical Subject Heading (MeSH) Categories for DICHLORPHENAMIDE

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

Market Dynamics and Financial Trajectory for Dichlorophenamide

Last updated: July 28, 2025

Introduction

Dichlorophenamide (DCP) is a carbonic anhydrase inhibitor primarily used in the management of specific neurological and metabolic disorders. As a derivative of the chlorophenamide class, it shares pharmacological properties with other carbonic anhydrase inhibitors like acetazolamide. Despite being a niche pharmaceutical, DCP’s market dynamics are shaped by its clinical indications, regulatory status, patent landscape, and emerging research. This analysis explores the current market environment, financial prospects, and competitive factors affecting Dichlorophenamide.

Pharmacological Profile and Clinical Applications

Dichlorophenamide functions by inhibiting carbonic anhydrase enzymes, which regulate acid-base balance and fluid secretion. Its primary licensed indication is the treatment of medically refractory idiopathic intracranial hypertension (IIH) and secondary trials for other neurological conditions such as episodic ataxia. The drug’s efficacy in reducing intracranial pressure has established niche clinical utility. Nonetheless, its adoption remains limited outside specialized centers due to side effect profiles—primarily metabolic disturbances and renal issues—and the availability of alternative therapies.

Market Landscape and Key Drivers

Regulatory and Patent Environment

Currently, Dichlorophenamide is not under active patent protection, having entered generic markets in many regions. The absence of exclusivity significantly impacts revenue potential, constraining investment and development. Nevertheless, orphan drug designations or exclusivities granted by regulatory authorities for specific indications could influence market exclusivity and development incentives.

Competitive Dynamics

The competitive landscape features several carbonic anhydrase inhibitors, including acetazolamide and methazolamide, with broader approval and established clinical use. DCP’s niche positioning limits its market size; however, it benefits from specialized applications where alternatives are less effective.

Prescriber Trends and Adoption Barriers

The adoption of Dichlorophenamide hinges on clinician familiarity, perceived efficacy, and side effect profile. Given the availability of more established treatments, DCP faces barriers to widespread use. Nonetheless, in cases of refractory IIH, where existing therapies falter, DCP may see increased prescription rates.

Market Size and Revenue Projections

Due to its limited indications, the global market for Dichlorophenamide remains relatively small—estimated at a few million dollars annually. The total addressable market is primarily confined to specialized neurology centers. If a new indication emerges, or if regulatory agencies extend approval, market size could expand considerably.

Financial Trajectory and Outlook

Current Revenue Streams

Presently, revenue derives mainly from off-label use, compounded by generic sales. Pharmaceutical companies may experience minimal margins due to competition and patent expiry. Without exclusive rights or significant market penetration, forecasted revenues are modest.

Growth Opportunities

  • New Indications: Clinical trials exploring DCP’s efficacy for conditions like metabolic alkalosis or specific epilepsy subtypes could unlock additional revenue streams.
  • Formulation Innovations: Sustained-release or combination formulations could enhance convenience, improve compliance, and potentially command premium prices.
  • Regulatory Incentives: Patents or orphan drug designations could offer market exclusivity, incentivizing investment and elevating financial forecasts.

Risks and Challenges

  • Market Penetration: Limited awareness and clinician familiarity could hinder uptake.
  • Side Effect Profile: Concerns about metabolic disturbances may constrain therapeutic applications.
  • Competitive Alternatives: More established drugs with proven safety and efficacy profiles are entrenched in treatment algorithms.

Emerging Trends and Future Outlook

The future financial trajectory for Dichlorophenamide will depend largely on research developments and regulatory strategies. Increased funding for neurological disorder research could catalyze new uses, while advancements in personalized medicine might refine patient selection, boosting efficacy and adoption. However, without intellectual property protections or major breakthroughs, DCP’s market growth remains constrained.

Pharmaceutical companies may consider licensing, strategic collaborations, or clinical development investments aimed at repositioning DCP. Furthermore, health systems’ acceptance and insurance reimbursement policies will influence patient access and, consequently, revenue streams.

Regulatory Landscape Impact

Regulatory agencies’ perspectives on safety and efficacy are critical. If approval paths for new indications are streamlined, or if safety profiles improve through formulation modifications, DCP’s financial prospects could improve markedly. Conversely, safety concerns could diminish its market potential.

Conclusion

Dichlorophenamide’s market dynamics are shaped by its niche clinical uses, patent expiration, and competition from entrenched therapies. While current revenues are limited, emerging research and strategic regulatory pathways could influence its financial trajectory. Companies seeking to capitalize on DCP’s potential must navigate clinical, regulatory, and commercial complexities, aligning development strategies to address unmet medical needs with optimized formulations and targeted indications.


Key Takeaways

  1. Limited Market Potential: DCP’s current applications and patent expirations restrict its revenue-generating capacity, confining it to a niche market.
  2. Research-Driven Opportunities: Expanding clinical trials could reveal new indications, unlocking growth and increasing market size.
  3. Regulatory Strategies are Critical: Securing orphan drug exclusivity or patent protections could significantly enhance profitability.
  4. Competitive Challenges: Established therapies like acetazolamide maintain dominant positions due to broader approval and clinical familiarity.
  5. Investment and Development Risks: Safety concerns, market acceptance, and competitive landscape pose hurdles requiring strategic planning.

FAQs

1. What are the primary clinical indications for Dichlorophenamide?
Dichlorophenamide is mainly indicated for treating idiopathic intracranial hypertension and has been explored for other neurological conditions. Its off-label use is limited due to side effects and competition from better-established drugs.

2. How does patent expiration affect Dichlorophenamide's market?
Patent expiration leads to generic competition, substantially reducing exclusivity and pricing power, which diminishes profitability and deters investment in further development.

3. Are there any regulatory incentives that could boost DCP’s market?
Yes; orphan drug designation or new indication approvals can provide market exclusivity and financial incentives, potentially revitalizing its commercial outlook.

4. What emerging research trends could influence Dichlorophenamide’s market trajectory?
Research into new neurological and metabolic applications, formulation enhancements, and safety improvements could expand its use and market share.

5. What are the main barriers to DCP’s wider adoption?
Limited awareness, side effect concerns, competition from established drugs, and lack of significant patent protection are primary hurdles to broader clinical adoption.


Sources:

  1. [Clinical Pharmacology Literature on Dichlorophenamide]
  2. [FDA Drug Approvals and Regulatory Data]
  3. [Market Research Reports on Niche Neurological Drugs]
  4. [Patent Databases on Chlorophenamide Derivatives]

(Note: Specific references are based on existing knowledge and hypothetical datasets pertinent to the analysis.)

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.