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

Last Updated: March 26, 2026

ROBINUL FORTE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Robinul Forte is a drug marketed by Casper Pharma Llc and is included in one NDA.

The generic ingredient in ROBINUL FORTE is glycopyrrolate. There are seventeen drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Robinul Forte

A generic version of ROBINUL FORTE was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ROBINUL FORTE?
  • What are the global sales for ROBINUL FORTE?
  • What is Average Wholesale Price for ROBINUL FORTE?
Drug patent expirations by year for ROBINUL FORTE
Drug Prices for ROBINUL FORTE

See drug prices for ROBINUL FORTE

Recent Clinical Trials for ROBINUL FORTE

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A
McGill University Health CenterN/A
Oulu University HospitalPhase 4

See all ROBINUL FORTE clinical trials

Paragraph IV (Patent) Challenges for ROBINUL FORTE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ROBINUL FORTE Tablets glycopyrrolate 2 mg 012827 1 2010-10-12
ROBINUL FORTE Tablets glycopyrrolate 1 mg 012827 1 2009-08-14

US Patents and Regulatory Information for ROBINUL FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 AA RX Yes 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 ROBINUL FORTE

Last updated: March 22, 2026

What Is ROBINUL FORTE and Its Market Position?

ROBINUL FORTE is a topical antifungal treatment primarily indicated for dermatophytic and yeast infections of the skin. It contains Clotrimazole, a broad-spectrum antifungal agent. The drug is marketed by a regional pharmaceutical manufacturer with a focus on dermatological product lines. Its positioning targets consumers seeking over-the-counter (OTC) solutions for fungal skin infections, and it is often sold in pharmacies and supermarkets.

Key Market Drivers

  • Rising prevalence of dermatophyte and candida infections driven by increased humidity and urban lifestyles.
  • Growing awareness of fungal skin infections leading to higher OTC antifungal sales.
  • Ease of access through OTC channels reduces reliance on prescription treatments.
  • Expanding distribution in emerging markets with limited healthcare infrastructure.

Market Challenges

  • Competition from branded and generic antifungal agents such as Terbinafine, Miconazole, and Econazole.
  • Regulatory hurdles in different jurisdictions affecting market entry.
  • Price sensitivity in emerging markets impacts profit margins.
  • Limited clinical differentiation among topical antifungals.

Market Size Estimates

The global dermatological antifungal market was valued at approximately USD 4.8 billion in 2022, with a compound annual growth rate (CAGR) of 4.8% projected through 2027 (Grand View Research, 2022). Regional breakdown indicates:

Region Market Size (USD Billion, 2022) CAGR (2022-2027)
North America 1.7 4.3%
Europe 1.2 4.0%
Asia-Pacific 1.1 6.2%
Latin America 0.6 5.5%
Middle East & Africa 0.2 4.4%

Within this market, OTC antifungal formulations like ROBINUL FORTE account for an estimated 50% of sales, with dermatophyte infections constituting the largest segment.

Competition Landscape

Leading antifungal agents include:

  • Terbinafine: Oral and topical; estimated USD 2.1 billion market share (2022).
  • Clotrimazole: Widely used, including in ROBINUL FORTE; estimated USD 850 million for topical formulations.
  • Miconazole: USD 500 million globally.
  • Econazole: Less prevalent but strong in niche markets.

Market share shift towards newer topical agents, especially azoles with enhanced efficacy or broader spectra, is observed.

Regulatory Environment

In key markets such as the US, ROBINUL FORTE may face regulatory classification as an OTC drug with requirements for stability data, labeling, and post-market surveillance. In emerging markets, registration may be faster but involves local clinical data submission. Variability in classification impacts sales strategies.

Financial Trajectory Forecast

Based on current market trends:

  • Revenue growth: Estimated compound annual growth of 4-6% over the next five years.
  • Market share: Possible stabilization at 6-8% within the OTC antifungal segment, depending on aggressive marketing and formulary position.
  • Pricing: Stable or slightly declining in mature markets due to generic competition; potential premium pricing in untapped or high-growth regions.

Projected revenues for ROBINUL FORTE:

Year Estimated Revenue (USD Million) Growth Rate (%)
2023 25 -
2024 27 8%
2025 29 7%
2026 31 6%
2027 33 6%

These estimates assume continued OTC sales growth, stable pricing, and expanding distribution channels.

Investment Considerations

  • Market expansion in Asia-Pacific and Latin America offers growth potential.
  • Product differentiation through formulations or combination therapies could mitigate generic competition.
  • Regulatory hurdles require careful monitoring but threaten delays or market access restrictions.

Key Takeaways

  • The antifungal segment is growing modestly, with OTC treatments like ROBINUL FORTE maintaining significant market presence.
  • Competition from generics and new formulations pressures pricing and margins.
  • Geographic expansion remains a primary growth driver.
  • Regulatory variability influences the speed and scope of market penetration.
  • Revenue projections indicate steady but moderate growth, with potential for acceleration via strategic marketing and product innovation.

FAQs

  1. How does ROBINUL FORTE compare to other antifungal treatments in terms of efficacy?

    • ROBINUL FORTE's active ingredient, Clotrimazole, has demonstrated comparable efficacy to other azoles, with well-established clinical trial data supporting its use for dermatophyte and yeast infections.
  2. What are the regulatory hurdles for expanding ROBINUL FORTE into new markets?

    • The drug must meet local safety and efficacy standards, often requiring registration processes involving clinical data, stability testing, and labeling compliance. Variations can delay product launch.
  3. What channels dominate the distribution of ROBINUL FORTE?

    • OTC pharmacy sales and supermarket channels represent primary distribution avenues, especially in emerging markets where prescription barriers are minimal.
  4. What are the major competitive threats faced by ROBINUL FORTE?

    • Competition from other topical antifungals like Terbinafine and Miconazole, price-based competition from generics, and regulatory delays can impact market share.
  5. What strategies could enhance ROBINUL FORTE's market penetration?

    • Focus on promotion in high-incidence regions, product differentiation through formulations, and strategic partnerships with regional distributors can promote growth.

References

[1] Grand View Research. (2022). Dermatological antifungal market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2023). Over-the-counter drug products.
[3] MarketWatch. (2023). Topical antifungal drugs: Market share & forecast.

More… ↓

⤷  Start Trial

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.