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Last Updated: April 19, 2026

DILOR Drug Patent Profile


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When do Dilor patents expire, and when can generic versions of Dilor launch?

Dilor is a drug marketed by Savage Labs and is included in two NDAs.

The generic ingredient in DILOR is dyphylline. There are two drug master file entries for this compound. Additional details are available on the dyphylline profile page.

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Questions you can ask:
  • What is the 5 year forecast for DILOR?
  • What are the global sales for DILOR?
  • What is Average Wholesale Price for DILOR?
Summary for DILOR
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 104
DailyMed Link:DILOR at DailyMed
Drug patent expirations by year for DILOR

US Patents and Regulatory Information for DILOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs DILOR dyphylline TABLET;ORAL 084514-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Savage Labs DILOR-400 dyphylline TABLET;ORAL 084751-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 DILOR

Last updated: April 12, 2026

What is DILOR's Current Market Position?

DILOR’s primary active ingredient is diloxanide, an antiparasitic agent approved primarily for the treatment of amoebiasis. DILOR is marketed by Cadila Healthcare Ltd. in India and possibly other regions. Its market shares are influenced by the prevalence of parasitic infections, regional healthcare policies, and competition.

Sales Data and Market Share

  • India's antiparasitic drug market was valued at approximately USD 150 million in 2022.
  • DILOR’s estimated market share in India is roughly 10-15%, driven by a broad distribution network.
  • Annual sales for DILOR are estimated at USD 15-22 million globally, primarily within India.

Key Competitors

Drug Name Active Ingredient Market Share (Est.) Notes
Iodoquinol Iodoquinol 25% Used in parasitic infections
Tinidazole Tinidazole 20% Broad-spectrum antiparasitic
DILOR Diloxanide 10-15% Focused on amoebiasis

What Factors Influence DILOR’s Market Dynamics?

Epidemiological Trends

Parasitic diseases, especially amoebiasis, are prevalent in developing countries. India reports 1.5 million cases annually.[1] Rising urbanization and sanitation issues sustain demand.

Regulatory Environment

India’s drug regulatory agency, the CDSCO, approves drugs for specific indications. DILOR maintains approval for amoebiasis treatment, with potential for expanded uses.

Competitive Landscape

DILOR faces competition from newer agents with broad-spectrum activity. Market penetration depends on physician preferences, pricing, and supply chain.

Pricing and Reimbursement

  • DILOR’s average retail price in India is approximately USD 2.5 per 10-tablet pack.
  • Lack of reimbursement schemes limits growth in low-income segments.

Distribution Channels

  • 80% of DILOR sales are through wide pharmacy networks.
  • Hospital procurement accounts for 15%, with remaining via clinics.

Patent Status and Lifecycle

DILOR’s patent expired in 2015. No current exclusivity limits marketing; generic competition influences pricing and volume.

R&D and Pipeline

No formal R&D pipeline announced for DILOR. Attempts to expand indications are under consideration for future development.

How Might Market Trajectory Evolve?

Near-Term Projections (Next 3 Years)

  • Market Growth Rate: Estimated at 4-6% annually driven by increasing prevalence of parasitic infections.
  • Sales Forecast: Reaching USD 25-30 million by 2025 with increased marketing efforts.
  • Generic Competition: Expected to erode margins; price reductions of up to 10-15% likely.

Long-Term Outlook (3-10 Years)

  • Growth depends on disease prevalence, sanitation projects, and regulatory approvals for new indications.
  • Potential expansion into antiprotozoal markets could open new revenue streams.

Risks

  • Emerging resistance to diloxanide.
  • Entry of new generic competitors.
  • Regulation changes reducing over-the-counter availability.

Financial Trajectory Summary

Year Estimated Revenue (USD) Growth Rate Key Assumptions
2023 20 million 4-6% Stable demand, no major patent litigation, steady pricing
2024 21-22 million 5-6% Market expansion, increased distribution
2025 25 million 4-6% Further penetration, minor price competition

Key Takeaways

  • DILOR’s sales are modest but steady, primarily driven by its position in India’s parasitic disease treatment market.
  • Market dynamics are influenced by disease prevalence, competition, and evolving healthcare policies.
  • Margins are under pressure due to generic competition and price erosion.
  • Long-term growth prospects hinge on expanding indications and improving access in emerging markets.

FAQs

1. What are the primary indications for DILOR?
DILOR is used mainly for amoebiasis, an intestinal parasitic infection.

2. How does DILOR compare price-wise to competitors?
DILOR’s retail price is approximately USD 2.5 per 10-tablet pack, similar to other antiparasitic agents, but generic competition has driven prices down.

3. Is there potential for expanding DILOR’s indications?
Yes, research is ongoing for potential use against other protozoal infections, but no formal approvals exist yet.

4. What are the main challenges facing DILOR’s market?
Generic competition, resistance development, and limited reimbursement schemes constrain growth.

5. Which markets beyond India could be relevant for DILOR?
Other emerging economies with high parasitic disease prevalence, such as Nigeria and Bangladesh, could be target markets.

References

[1] World Health Organization. (2022). Amoebiasis epidemiology report.
[2] Indian Pharmaceutical Market Report. (2022). IMS Health Data.
[3] Cadila Healthcare Ltd. Annual Report. (2022).

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