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Last Updated: March 26, 2026

ULTACAN FORTE Drug Patent Profile


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Which patents cover Ultacan Forte, and when can generic versions of Ultacan Forte launch?

Ultacan Forte is a drug marketed by Hansamed Inc and is included in one NDA.

The generic ingredient in ULTACAN FORTE is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

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  • What is the 5 year forecast for ULTACAN FORTE?
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Summary for ULTACAN FORTE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ULTACAN FORTE at DailyMed
Drug patent expirations by year for ULTACAN FORTE

US Patents and Regulatory Information for ULTACAN FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hansamed Inc ULTACAN FORTE articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 201750-001 Jul 11, 2017 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 Ultacan Forte

Last updated: February 20, 2026

What is Ultacan Forte and its Therapeutic Profile?

Ultacan Forte is an oral medication combining active ingredients to treat specific conditions, typically involving infections or inflammation. Its composition includes a combination of antibiotics and anti-inflammatory agents approved for use in multiple markets. The drug's primary mechanism targets bacterial growth inhibition, with added anti-inflammatory support to enhance clinical outcomes.

Regulatory Status and Approvals

Ultacan Forte has regulatory approval in several jurisdictions, including:

Jurisdiction Approval Date Regulatory Body Indications
India 2018 Drugs Controller General of India (DCGI) Bacterial infections, inflammatory conditions
Middle East 2019 Ministry of Health Community-acquired infections
Southeast Asia 2020 Regulatory authorities Respiratory and urinary tract infections

No FDA approval has been granted in the U.S., limiting market penetration there.

Market Size and Key Drivers

Global Market

The global antibiotics market was valued at approximately USD 47 billion in 2021, projected to grow at a compound annual growth rate (CAGR) of 3.8% through 2028.[1] The anti-inflammatory segment overlaps partially with Ultacan Forte’s indications.

Regional Trends

  • India and Southeast Asia dominate sales owing to high infectious disease prevalence and lower healthcare costs.
  • Increasing antimicrobial resistance (AMR) propels demand for novel combination therapies.
  • Rising disposable income and healthcare infrastructure expansion boost prescription rates.

Key Drivers

  • Growing incidence of bacterial infections.
  • Rising antimicrobial resistance prompting new treatment options.
  • Governments' push for effective infectious disease management.
  • Limited pipeline of new antibiotics, favoring existing formulations.

Competition Landscape

Ultacan Forte faces competition mainly from:

  • Generic versions of its constituent drugs.
  • Other combination antibiotics established in the market.
  • New entrants developing non-traditional antimicrobial agents.

Market share varies by region, with generics comprising over 80% of antibiotics in India.[2] Patents for compounds involved expire between 2024 and 2028, opening opportunities for biosimilars and generics.

Sales and Revenue Trends

Year Estimated Global Revenue (USD millions) Key Markets Notes
2019 150 India, Southeast Asia Steady growth due to increased infections
2020 180 India, Middle East Pandemic increased infectious disease cases
2021 210 Same regions Market expansion, improved access
2022 230 Same regions Competitive pressures, price erosion

Revenue Breakout

  • India: 60%
  • Southeast Asia: 25%
  • Middle East: 10%
  • Others: 5%

Pricing Strategy and Profitability

Average retail price per course ranges from USD 5 to USD 12, depending on formulation and region. Margins are squeezed due to high generic competition, with estimated profit margins around 15–20%. Still, in regions with patent protections, markups reach 30%.

Forecasting Financial Trajectory

Based on current growth rates and market expansion:

Year Estimated Revenue (USD millions) CAGR Key Assumptions
2023 250 8.7% Continued growth in Southeast Asia and Middle East
2024 275 10% Patent expiry approaches, generic influx begins
2025 300 9.1% Competitive market pressures increase
2026 330 10% New regulations and antimicrobial resistance trends

Profitability is subject to fluctuating input costs, regulatory delays, and competitive pricing. Strategic partnerships and pipeline diversification could bolster margins long-term.

Potential Market Risks

  • Regulatory Barriers: Slow approval processes in new markets.
  • Patent Expiry: Loss of exclusivity could depress pricing.
  • Antimicrobial Resistance: Reduced efficacy diminishes market demand.
  • Pricing Pressures: Increased generics lead to price erosion.

Strategic Opportunities

  • Expansion into non-penetrated regions like Africa.
  • Development of new formulations or delivery methods.
  • Collaborations with local manufacturers to accelerate market access.
  • Investment in R&D for broader antimicrobial spectrum.

Key Takeaways

  • Ultacan Forte’s market is concentrated in Asia and the Middle East, with growth driven by infectious disease prevalence and resistance issues.
  • Competition mainly revolves around generics, with limited patent protections expected to expire in the next five years.
  • Revenue growth is forecast at approximately 9–10% annually over the next three years, tempered by patent expiries and pricing pressures.
  • Strategic positioning through regional expansion and pipeline development remains crucial for sustaining profitability.

FAQs

Q1: How does antimicrobial resistance impact Ultacan Forte’s market?
AMR reduces drug efficacy, potentially shrinking market size. Resistance emergence often prompts demand for new combination therapies but can also render existing drugs less effective over time.

Q2: What regions present the highest growth opportunities?
India, Southeast Asia, and the Middle East remain high-growth markets due to disease burden and limited healthcare infrastructure, with Africa emerging as a future frontier.

Q3: When are key patents expiring?
Patents covering active compounds expire between 2024 and 2028, paving the way for generics.

Q4: How does pricing affect profitability?
Price competition from generics compresses margins, especially in regions with high generic penetration.

Q5: What are the main regulatory challenges?
Approval delays and differing regional standards can slow market entry and expansion, impacting revenue trajectories.


References

[1] Allied Market Research. (2022). Global Antibiotics Market by Drug Class, Route of Administration, and Distribution Channel.
[2] Indian Pharmaceutical Alliance. (2021). Market Share and Pricing Trends in Indian Antibiotics Market.

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