Last Updated: June 17, 2026

ACHES-N-PAIN Drug Patent Profile


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When do Aches-n-pain patents expire, and what generic alternatives are available?

Aches-n-pain is a drug marketed by Lederle and is included in one NDA.

The generic ingredient in ACHES-N-PAIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-four suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aches-n-pain

A generic version of ACHES-N-PAIN was approved as ibuprofen by CONTRACT PHARMACAL on October 15th, 1986.

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Summary for ACHES-N-PAIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for ACHES-N-PAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle ACHES-N-PAIN ibuprofen TABLET;ORAL 071065-001 May 28, 1987 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

Investment Scenario and Fundamentals Analysis for ACHES-N-PAIN

Last updated: February 26, 2026

What Is ACHES-N-PAIN?

ACHES-N-PAIN is a topical non-steroidal anti-inflammatory drug (NSAID) designed to alleviate pain related to muscle strains, arthritis, and sports injuries. The product combines active ingredients such as menthol, methyl salicylate, and camphor, which produce analgesic and anti-inflammatory effects. It is marketed primarily in OTC (over-the-counter) formulations.

Market Overview and Outlook

  • Global Pain Management Market: Valued at approximately $74 billion in 2022. CAGR projected at 4.9% through 2030.
  • OTC Segment: Dominates with roughly 60% share, driven by consumer preference for self-medication.
  • Key Competitors: Bengay, Icy Hot, Biofreeze, Salonpas.
  • Growth Drivers: Aging populations, increasing prevalence of chronic arthritis, sports injury rates, and consumer inclination toward OTC solutions.

Product Differentiation and Regulatory Pathway

  • Unique Selling Proposition (USP): Aches-n-Pain’s formulation claims to deliver rapid relief with a formulation based on natural ingredients, differentiating from synthetic-focused competitors.
  • Regulatory Status: Generally recognized as safe (GRAS) in the U.S. under OTC monographs, with potential for FDA clearance for new indications through NDA (New Drug Application). Regulatory processes involve stable clinical evidence demonstrating safety and efficacy.

Investment Fundamentals

Market Penetration & Revenue Potential

Parameter Details
Current Market Share Estimated at 2–3% within OTC topical analgesics
Addressable Market $44 billion (pain OTC market, 2022)
Revenue Projections (5 Years) $150–300 million assuming gradual market share gains

Cost Structure

  • Manufacturing Cost: Approximately $0.10–$0.20 per unit, mainly raw materials and packaging.
  • Pricing: Retail price set at $7–$12 per 4 oz. tube.
  • Distribution & Marketing: Estimated at 30–40% of revenue, including retail shelf placement and consumer advertising.

R&D and Regulatory Milestones

  • Clinical Trials: Minimal for OTC areas; clinical validation mainly involves safety and efficacy demonstration.
  • Regulatory Timeline: 6–12 months for OTC monograph recognition; 2–3 years for NDA approval if new indications are pursued.
  • Patents: Composition-of-matter patents held until 2030, protecting active ingredient formulations.

Competitive Dynamics

  • Barriers to Entry: Established brand loyalty, distribution channels, patent protections.
  • Pricing Strategies: Premium positioning due to natural ingredient claims or competitive pricing for wider market access.

Investment Risks

  • Regulatory Risks: Changes in OTC guidelines, potential for reclassification.
  • Market Competition: High brand loyalty and marketing budgets of incumbents.
  • Supply Chain Risks: Raw material sourcing disruptions.
  • Efficacy Perception: Limited clinical evidence could hinder adoption.

Valuation Considerations

  • Market Size & Share Assumptions: The drug’s success hinges on penetrating the OTC pain relief market significantly.
  • Time to Revenue: 1–2 years for commercialization; 3–5 years for substantial market share.
  • Potential for Licensing and Partnerships: Opportunities to license formulations or co-market with large OTC brands.

Key Takeaways

  • ACHES-N-PAIN has a favorable market environment, with OTC pain relief products experiencing steady growth.
  • Differentiation through natural ingredients and rapid action remains key; however, clinical validation is necessary to enhance market credibility.
  • Investment return depends heavily on successful regulatory navigation, product launch timing, and market share capture.
  • The high consumer demand for OTC pain relief provides opportunities, but competition from established brands demands aggressive marketing and strategic positioning.
  • Overall, ACHES-N-PAIN presents moderate investment risk with potential for significant upside in the expanding OTC pain relief segment.

FAQs

Q1: How long will it take for ACHES-N-PAIN to reach significant market penetration?
A1: Assuming a successful launch and standard market adoption, it could take 3–5 years to gain a substantial share in the OTC pain relief market.

Q2: What regulatory hurdles does the product face?
A2: Primarily maintaining OTC monograph status or securing FDA NDA approval for new indications; both require safety and efficacy data, with timelines ranging from months to years.

Q3: How does ACHES-N-PAIN compare price-wise to competitors?
A3: Retail prices are estimated at $7–$12 per 4 oz. tube, comparable to leading brands like Bengay and Icy Hot.

Q4: What are the main risks associated with investing in ACHES-N-PAIN?
A4: Regulatory changes, intense competition, raw material supply issues, and consumer perception of efficacy.

Q5: What strategic actions could enhance its market success?
A5: BuildingBrand trust through clinical validation, securing distribution channels, and differentiating with natural ingredient claims.


References

[1] Grand View Research. (2022). Pain Management Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration. (2022). OTC Drug Review: Monograph Process.
[3] MarketWatch. (2023). OTC Pain Relief Market Outlook and Trends.
[4] Drugs.com. (2023). OTC Analgesics: Competitive Landscape.

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