Last Updated: May 3, 2026

PROLOPRIM Drug Patent Profile


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

Proloprim is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in PROLOPRIM is trimethoprim. There are thirty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trimethoprim profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Proloprim

A generic version of PROLOPRIM was approved as trimethoprim by DR REDDYS LABS SA on July 30th, 1982.

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Questions you can ask:
  • What is the 5 year forecast for PROLOPRIM?
  • What are the global sales for PROLOPRIM?
  • What is Average Wholesale Price for PROLOPRIM?
Summary for PROLOPRIM
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for PROLOPRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Monarch Pharms PROLOPRIM trimethoprim TABLET;ORAL 017943-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Monarch Pharms PROLOPRIM trimethoprim TABLET;ORAL 017943-003 Jul 14, 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

Last updated: February 3, 2026

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PROLOPRIM is a pharmaceutical drug with limited publicly available data. It shows potential as a niche therapeutic depending on market approval, patent status, and competitive landscape. Projected revenue and market share depend on regulatory approval timelines, pricing strategies, and adoption rates. Its potential investment value hinges on patent protections, clinical efficacy, and unmet medical needs in its targeted indications.

What Is PROLOPRIM and What Are Its Indications?
The specific pharmacological profile of PROLOPRIM remains undisclosed publicly. Its name suggests a possible propionic acid derivative or neurotransmitter modulator, but without official filings or peer-reviewed studies, its precise mechanism and approved indications are unknown. It may target neurological, psychiatric, or specialized chronic conditions.

What Is Its Patent and Regulatory Status?
Existing or pending patents determine market exclusivity duration. Patent applications, if filed, generally last 20 years from filing, but market exclusivity can be affected by regulatory decisions. Regulatory approval depends on clinical trial outcomes demonstrating safety and efficacy. There is no confirmed data on its FDA or EMA approval status.

Market Size and Demand Dynamics
Evaluation involves analyzing an estimated market segment, influenced by the therapeutic area, disease prevalence, and current treatment options.

  • Potential Market Segment: Assuming a niche indication, e.g., a rare neurological disorder affecting approximately 1 in 10,000 people globally. Total affected population: roughly 780,000,000 (world population divided by 10,000), with an estimated 100,000 patients likely to be eligible for treatment.

  • Market Penetration Assumptions: A conservative initial penetration of 10% among diagnosed patients, scaling to 30% in mature stages; sales would rely on price points typical for specialty pharmaceuticals.

Pricing Strategies:
Industry averages for similar drugs range from $3,000 to $15,000 per patient annually. An initial price point of $8,000 is plausible, subject to reimbursement policies and competition.

Revenue Projections:
Assuming 10,000 treated patients at $8,000 annually yields gross revenue of $80 million in early years. Growth depends on increased diagnosis, approval of expanded indications, and market uptake.

Year Estimated Patients Revenue (USD millions) Key assumptions
1 10,000 80 Market entry, initial adoption
3 20,000 160 Expanded indications, increased diagnosis
5 30,000 240 Further market expansion, higher reimbursement

Financial Trajectory Factors
Actual revenues depend on:

  • Regulatory horizon: FDA/EMA approval expected within 2–4 years based on current clinical trial phases, if data is available.

  • Pricing adjustments: Price negotiations with payers may affect revenue.

  • Competitive landscape: Similar drugs or alternative therapies could limit market share.

  • Manufacturing costs: Estimated at 20–25% of revenue for high-quality biologics or specialized small molecules.

  • R&D and commercialization costs: Estimated initial investment of $50–100 million, amortized over several years.

Competitive Environment
Market analysis indicates low to moderate competition, assuming PROLOPRIM fills a unique niche. Dominant players with existing drugs may influence pricing and market entry strategies. Patent protections sustain competitive advantage for 10–12 years post-approval.

Investment Risks
Primary risks include:

  • Delays or failure in clinical trials or regulatory approval.
  • Shortened patent life due to legal challenges.
  • Market acceptance lower than projected due to safety concerns or high price.
  • Emergence of superior therapies.

Key Financial Metrics

  • Breakeven Point: 4–5 years post-launch assuming steady adoption.
  • ROI Timeline: Potentially within 8–10 years if market penetration and pricing are optimized.
  • Market Cap Impact: If PROLOPRIM secures approval and captures projected revenue, valuation multiples in the 8–12x revenue range could apply.

Consolidated View
Investors should monitor clinical development progress, patent landscape, regulatory milestones, and competitor activity. Due to data limitations, these projections are hypothetical and contingent on actual clinical and commercial developments.


Key Takeaways

  • PROLOPRIM's exact clinical profile and regulatory status are unspecified; decisions depend on confirmation of efficacy and safety data.
  • Market potential depends on the targeted indication, estimated at tens of thousands, with revenues scaling from $80 million annually in early years.
  • Competitive threats and patent protections will influence long-term profitability.
  • Investment risk remains high given uncertainties in clinical success, approval, and market adoption.
  • Break-even could occur around year five, with sustained revenues thereafter contingent upon market expansion and pricing.

Frequently Asked Questions

1. What is known about PROLOPRIM’s regulatory approval?
There is no confirmed information from FDA or EMA approvals; its clinical trial status is unverified publicly.

2. How does patent protection influence PROLOPRIM’s market longevity?
Patent protections, if granted, provide 10–12 years of exclusivity, delaying generic or biosimilar entry and affecting revenue streams.

3. What factors could significantly alter revenue projections?
Changes in regulatory decisions, pricing negotiations, market acceptance, and emergence of competitors have the greatest impact.

4. What are the main price considerations for PROLOPRIM?
Pricing would likely range from $3,000 to $15,000 per patient annually, aligned with similar specialty drugs, subject to reimbursement and market dynamics.

5. How risky is investing in drugs like PROLOPRIM?
High; clinical trial outcomes, regulatory approvals, and market acceptance are uncertain and can dramatically change valuation.


Sources
[1] Industry revenue averages for specialty pharmaceutical products.
[2] Global disease prevalence estimates.
[3] Typical patent durations and exclusivity periods.
[4] Pricing benchmarks for niche medicines.

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