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Last Updated: March 29, 2026

NUPRIN Drug Patent Profile


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Which patents cover Nuprin, and what generic alternatives are available?

Nuprin is a drug marketed by Bristol Myers and Kenvue Brands and is included in three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Nuprin

A generic version of NUPRIN was approved as ibuprofen by CONTRACT PHARMACAL on October 15th, 1986.

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Drug patent expirations by year for NUPRIN
Recent Clinical Trials for NUPRIN

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SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
National Institutes of Health Clinical Center (CC)Phase 1

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Pharmacology for NUPRIN

US Patents and Regulatory Information for NUPRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers NUPRIN ibuprofen TABLET;ORAL 072035-001 Feb 16, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Kenvue Brands NUPRIN ibuprofen TABLET;ORAL 019012-002 Jul 29, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers NUPRIN ibuprofen TABLET;ORAL 072036-001 Feb 16, 1988 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 NUPRIN

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 for NUPRIN

Last updated: March 4, 2026

What is NUPRIN?

NUPRIN is a trade name for acetaminophen (paracetamol), a widely used analgesic and antipyretic medication recognized for its effectiveness in reducing pain and fever. It is available over the counter in numerous countries, sold in various formulations including tablets, capsules, liquids, and powders.

How has the NUPRIN market developed?

The market for NUPRIN is categorized by consistent demand fueled by its widespread use, regulatory approvals, and consumer preferences. Key factors influencing market dynamics include:

  • Global Usage Scope: NUPRIN is a core component of OTC pain management, especially in North America, Europe, and parts of Asia. The global acetaminophen market was valued at approximately USD 1.2 billion in 2022, with an expected CAGR of 4.2% from 2023 to 2030 [1].

  • Regulatory Environment: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), have approved NUPRIN for over-the-counter (OTC) use. Regulations on dosage, packaging, and safety warnings influence market expansion, especially following alerts regarding overdose-related hepatotoxicity.

  • Market Penetration: NUPRIN's branding by major pharmaceutical companies, such as Johnson & Johnson and GlaxoSmithKline, maintains dominant market positions. Generic competition has increased, providing more affordable options but also introducing price pressures.

  • Consumer Preference Trends: The shift towards OTC medications as first-line pain relief options promotes continuous demand. Conversely, concerns about overdose risks led to stricter labeling and dosage guidelines, impacting purchasing patterns.

  • Emerging Markets: Growth in countries like China and India, driven by expanding healthcare infrastructure and increased health awareness, presents opportunities for market expansion.

What is the financial performance trajectory?

  • Revenue Trends: Major producers report consistent revenues from NUPRIN or acetaminophen products. Johnson & Johnson's OTC division reported revenues exceeding USD 4 billion in 2022, with acetaminophen products contributing a significant share [2].

  • Pricing Strategies: Generic manufacturers typically price NUPRIN products 20-40% lower than branded counterparts, influencing overall market profitability. Price competition has stabilized margins but maintains high volume sales.

  • Research and Development (R&D): Investment in reformulations (e.g., extended-release variants), combination drugs, and safety profiling accounts for an estimated USD 50-70 million annually by leading firms, aimed at extending product lifecycle and addressing safety concerns.

  • Market Opportunities: Innovations in formulation (e.g., chewables, rapid-dissolve), combination therapies (with caffeine or other analgesics), and digital health integration (reminder apps, dosage tracking) forecast future revenue streams.

  • Impact of Regulatory Actions: Recent restrictions on high-dose formulations and laundering restrictions in certain countries can restrict revenue growth temporarily, but long-term stability persists due to high demand.

How do regulatory, competitive, and societal factors influence NUPRIN’s financial outlook?

  • Regulatory Restrictions: Stricter limits on maximum daily dose (e.g., FDA’s 4,000 mg/day cap) may reduce per-unit sales volume but improve safety profiles. In some markets, stricter OTC access or prescription requirements may depress immediate sales but expand premium formulation sales.

  • Competitive Landscape: The rise of alternative OTC analgesics like NSAIDs (ibuprofen, naproxen) impacts NUPRIN’s market share. Generic competition erodes margins but sustains overall volume.

  • Safety Concerns and Public Perception: Publicized hepatotoxicity risks led to increased sales of safety-oriented formulations, such as combination products with lower per-dose acetaminophen content, aligning R&D with safety improvements.

  • COVID-19 Pandemic Influence: Increased demand during the pandemic for fever and pain relief supported short-term sales spikes. Post-pandemic recovery suggests stabilization but emphasizes the importance of OTC medication resilience.

What are predicted future trends?

Feature Prediction Source/Reasoning
Market growth rate CAGR of 3.5%-4.5% through 2030 Continuing demand, emerging markets
Innovation in formulations Increased offerings like combination and extended-release R&D focus on safety and efficacy
Regulatory landscape Stricter dosage limits and labeling Global focus on overdose prevention
Digital health integration Adoption of digital adherence tools Increasing consumer engagement
Market share shifts Generics continue to dominate; branded sales stable Cost sensitivity drives generics

What are the critical risks and challenges?

  • Safety and regulatory hurdles: Overdose incidents prompt regulatory scrutiny, potentially leading to more restrictive policies.

  • Market saturation in mature regions: Limited growth prospects in North America and Europe, with higher emphasis on emerging markets.

  • Generic competition: Price wars may erode profit margins, necessitating innovation in formulation and branding.

  • Public perception: Negative publicity around safety issues can affect sales unless countered by rigorous safety improvements.

Key Takeaways

  • The NUPRIN market remains stable with consistent global demand fueled primarily by OTC sales.
  • Revenue is driven by high-volume, low-margin sales, with brands and generics competing on price and formulation.
  • Innovation focuses on safety, combination drugs, and patient engagement tools.
  • Regulatory trends toward stricter dosage limits could impact sales volume but improve safety profiles.
  • Emerging markets offer growth opportunities, offsetting saturation in developed countries.

FAQs

Q1: How does regulatory oversight impact NUPRIN sales? Regulatory agencies' restrictions on dosage and labeling influence consumer access and product formulations, impacting overall sales volume and profitability.

Q2: Who are the leading companies in the NUPRIN market? Johnson & Johnson, GlaxoSmithKline, and Teva Pharmaceuticals lead, with extensive OTC portfolios and global distribution channels.

Q3: Are there any upcoming innovations for NUPRIN? Yes, formulations such as extended-release tablets and combination therapies with caffeine aim to target specific consumer segments and improve safety profiles.

Q4: How significant is the emerging markets' influence? High; countries like China and India are experiencing rapid growth due to increased healthcare infrastructure and rising consumer demand for OTC analgesics.

Q5: What risks threaten future market stability? Regulatory changes, safety concerns, and market saturation pose ongoing risks, but innovation and market diversification provide mitigation strategies.


References

[1] Grand View Research. (2023). Acetaminophen Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/acetaminophen-market

[2] Johnson & Johnson Annual Report. (2022). OTC Division Financials. https://www.jnj.com/annual-report-2022

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