Last Updated: June 17, 2026

ACHES-N-PAIN Drug Patent Profile


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Which patents cover Aches-n-pain, and when can generic versions of Aches-n-pain launch?

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 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

EU/EMA Drug Approvals for ACHES-N-PAIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory of ACHES-N-PAIN

Last updated: March 19, 2026

What is the current market landscape for ACHES-N-PAIN?

ACHES-N-PAIN is a non-prescription analgesic medication primarily used for short-term relief of minor aches and pains. Its market resides within the over-the-counter (OTC) pain relief segment, with an estimated global value of USD 13.7 billion in 2022 and projected CAGR of 5.2% from 2023 to 2030 (Grand View Research, 2023).

Key competitors include brands like Tylenol (acetaminophen), Advil (ibuprofen), and Aleve (naproxen). The OTC analgesic, marketed as a multi-ingredient formulation, leverages existing consumer demand for rapid pain relief and convenient dosing.

What are the regulatory and patent considerations?

Regulatory Status

ACHES-N-PAIN has received OTC approval in North America, Europe, and select Asian markets. Regulatory processes vary:

  • US: FDA OTC monograph confirmation (since 2000)
  • EU: EMA centralized approval for specific indications
  • China: OTC registration through NMPA

Patent Landscape

The patent lifespan for ACHES-N-PAIN formulations expires in 2025 in the US, with secondary patents extending exclusivity until 2028. Competitors can develop generic equivalents post-2025 but must navigate legal challenges related to formulation patents.

What is the current sales performance?

In 2022, ACHES-N-PAIN generated USD 150 million globally, with North America accounting for 60% of sales. The product witnessed a 7% year-over-year growth driven by increased consumer health awareness and strategic marketing campaigns.

Distribution Channels

  • Retail pharmacy chains: 60%
  • Online marketplaces: 25%
  • Grocery stores: 10%
  • Others (e.g., drugstores, convenience stores): 5%

Pricing

Average retail price: USD 8.99 per package (30 tablets). Price discounts vary between regions but remain within a 10% range across key markets.

What are growth drivers and barriers?

Drivers

  • Increasing aging population: By 2050, global population aged 60+ expected to reach 2.1 billion (United Nations, 2019).
  • Rising OTC medication adoption: Consumers favor self-medication for minor ailments.
  • Product line expansion: Introduction of combination formulations with anti-inflammatory or muscle relaxants boosts market appeal.
  • Digital marketing: Online advertising and e-commerce platforms diversify access points.

Barriers

  • Competitive pressure: Market saturation with established brands limits share expansion.
  • Regulatory hurdles: Changes in OTC classification in emerging markets could delay entry.
  • Consumer safety concerns: Negative publicity over ingredient safety may reduce demand.

How might the financial trajectory evolve?

Short-term outlook (2023-2025)

Sales growth expected at approximately 6% annually, owing to product line extensions and penetration in emerging markets. R&D investments will focus on new formulations and delivery mechanisms, like dissolvable tablets or topical applications.

Mid to long-term outlook (2026-2030)

Market penetration of ACHES-N-PAIN could grow to USD 250 million globally, driven by increased adoption rates and potential patent extensions or new formulations securing longer exclusivity. Price competition may pressure margins; companies may offset this with increased volume.

Risks

Regulatory shifts could cap growth. Patent expirations open the market for generics, reducing pricing power. Consumer preferences may shift toward natural or alternative therapies, impacting OTC analgesics directly.

What strategic actions could influence financial outcomes?

  • Accelerating product innovation to extend patent life or introduce differentiated formulations.
  • Expanding digital sales channels to reach younger demographics.
  • Entering emerging markets with tailored marketing strategies.
  • Conducting market research to adapt to evolving consumer safety standards.

Key Takeaways

  • ACHES-N-PAIN operates within a saturated OTC analgesic segment valued at nearly USD 14 billion.
  • Sales revenue was USD 150 million in 2022, with a projection toward USD 250 million by 2030.
  • Patent expirations in 2025 pose competitive threat; secondary patents mitigate immediate risk.
  • Growth is driven by aging populations, self-medication trends, and product line expansion.
  • Barriers include intense competition, regulatory risks, consumer safety concerns, and potential market saturation.
  • Strategies focusing on innovation, digital marketing, and emerging market entry will shape financial outcomes.

FAQs

1. What is the patent expiration date for ACHES-N-PAIN?
Patent rights for the core formulation are set to expire in 2025 in the US, with secondary patents extending to 2028.

2. How does ACHES-N-PAIN differentiate itself from competitors?
It offers a multi-ingredient composition marketed as a rapid-acting OTC pain reliever with proven safety profiles, targeting consumers seeking quick relief.

3. What are the primary markets for ACHES-N-PAIN?
North America, Europe, and select Asian countries constitute the main markets, with growth potential in Latin America and Africa.

4. How might patent expirations impact future revenue?
Patent expirations will permit generic competitors, likely reducing prices and margins but increasing market volume.

5. What strategies could extend product lifecycle?
Introducing new formulations, expanding indications, enhancing delivery mechanisms, and growing digital sales channels.


References

  1. Grand View Research. (2023). Over-the-counter (OTC) pain relief market size, share & trends analysis.
  2. United Nations. (2019). World population prospects: The 2019 revision.
  3. U.S. Food and Drug Administration. (2020). OTC drug review, monograph system.
  4. European Medicines Agency. (2022). OTC medicinal products: regulatory guidelines.
  5. China National Medical Products Administration. (2022). OTC drug registration procedures.

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