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Last Updated: December 18, 2025

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-five 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 STRIDES PHARMA INTL on September 24th, 1986.

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

Identify potential brand extensions & 505(b)(2) entrants

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

See all NUPRIN clinical trials

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Kenvue Brands NUPRIN ibuprofen TABLET;ORAL 019012-002 Jul 29, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol Myers NUPRIN ibuprofen TABLET;ORAL 072036-001 Feb 16, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Kenvue Brands NUPRIN ibuprofen TABLET;ORAL 019012-001 May 18, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 the Pharmaceutical Drug: NUPRIN

Last updated: July 30, 2025

Introduction

NUPRIN, the brand name for acetaminophen (paracetamol), is a cornerstone in the analgesic and antipyretic segments. With extensive global sales and widespread over-the-counter (OTC) availability, its market trajectory remains indicative of broader pharmaceutical trends, including consumer health preferences, regulatory landscapes, and innovation pipelines. This analysis explores the market dynamics influencing NUPRIN’s standing and projects its financial trajectory amid evolving industry conditions.


Market Overview and Demand Dynamics

NUPRIN’s core utility in treating mild to moderate pain and fever positions it as a staple in both retail and healthcare settings. The global analgesics market was valued at approximately USD 23 billion in 2022, with acetaminophen accounting for a significant share owing to its safety profile, efficacy, and affordability [1]. The OTC segment contributes over 70% of sales, driven by consumer preference for accessible and low-cost medications.

Demand drivers include demographic shifts toward aging populations, increasing prevalence of chronic pain, and infectious diseases that elevate fever incidence. Additionally, the COVID-19 pandemic heightened awareness of fever management, bolstering sales of acetaminophen-based drugs. However, regulatory scrutiny over hepatotoxicity risks has led to tightened dosing guidelines, impacting sales volumes in certain regions.

Market Forces and Competitive Landscape

The competitive landscape comprises generics manufacturers, branded derivative players, and emerging pharma companies developing novel formulations. Major industry players like Johnson & Johnson, Pfizer, and local OTC leaders dominate, leveraging extensive distribution channels and consumer loyalty.

Generic manufacturers benefit from low production costs, enabling aggressive pricing strategies that pressure branded products like NUPRIN. In emerging markets, affordability remains a primary growth driver, prompting an expansion of generic acetaminophen offerings, which directly affects NUPRIN’s market share.

Innovation efforts focus on developing extended-release formulations, combination products (e.g., pain relief plus decongestants), and formulations with improved safety profiles to mitigate hepatotoxicity concerns. These innovations seek to differentiate products amid price-based competition.

Regulatory and Safety Considerations

Regulatory agencies such as the FDA and EMA impose strict guidelines on dosing, labeling, and safety monitoring due to the hepatotoxicity risk associated with acetaminophen overdose. Restrictions on maximum daily doses and clear consumer warnings have been implemented globally.

Safety concerns influence consumer perception and, consequently, sales patterns. Companies investing in safer formulations and clear communication can strengthen market position. Conversely, regulatory bans and restrictions can lead to revenue reductions, requiring proactive compliance strategies.

Pricing and Reimbursement Trends

Pricing strategies are influenced by generics proliferation and payer policies. In markets like the U.S., OTC sales are largely unaffected by reimbursement schemes, but prescription formulations may face affordability pressures from insurers and government programs aiming to control costs.

The prevalence of low-cost generics depresses prices of branded NUPRIN products, necessitating competitive pricing or value-added propositions to maintain margins. Additionally, the rise of online pharmacies expands distribution but invites regulatory challenges.


Financial Trajectory and Revenue Outlook

NUPRIN’s financial prospects hinge on several key factors:

  1. Market Penetration and Geographic Expansion
    Emerging markets such as India, China, and Latin America exhibit accelerating OTC sales growth owing to increasing healthcare access and population size. In these regions, the demand is projected to grow at a CAGR of approximately 4-6% over the next five years, bolstering revenues for established brands like NUPRIN.

  2. Product Innovation and Line Extensions
    Developing novel formulations—such as low-dose, extended-release, or combination products—can capture niche segments, justify premium pricing, and encourage brand loyalty. Given the mature nature of the acetaminophen market, innovation remains vital to sustain growth.

  3. Regulatory Adaptation and Safety Communication
    Effective management of safety concerns through transparent labeling and consumer education enhances brand reputation and maintains market share. Agencies may impose restrictions that could temporarily impact sales but adhering to safety standards ensures long-term viability.

  4. Competitive Pressure and Pricing Strategies
    The influx of low-cost generics demands aggressive pricing tactics from NUPRIN’s marketers. Strategic alliances and procurement efficiencies could offset margin pressures and preserve profitability.

  5. Impact of Potential Market Disruptions
    The ongoing development of alternative analgesics with improved safety profiles, including NSAIDs with fewer side effects or novel non-opioid therapies, could displace traditional acetaminophen products, influencing future revenue streams.

Projected Financial Trajectory

Based on current market conditions and strategic initiatives, NUPRIN’s global sales are forecasted to grow modestly at a CAGR of 2-3% over the next five years. The primary contribution of emerging markets—projected expansion of 4-6% CAGR—will offset stagnation or slight decline in mature markets.

Profit margins are expected to tighten due to pricing competition, with strategic formulation innovations offering opportunities for premium pricing. Overall, the financial trajectory remains cautiously optimistic, contingent upon successful innovation, regulatory compliance, and market expansion.


Conclusion

NUPRIN’s enduring presence in the analgesic market is driven by its affordability, safety profile, and broad consumer acceptance. However, market dynamics—marked by intense competition, regulatory challenges, and evolving safety concerns—require agile repositioning. Strategic investments in formulation innovation, geographic expansion, and safety reputation management will be critical to maintaining and enhancing NUPRIN’s financial trajectory.


Key Takeaways

  • The global acetaminophen market remains sizable, with growth largely driven by emerging markets and consumer health awareness.

  • Competition from generics and the need for innovation are primary factors influencing NUPRIN’s market share and profitability.

  • Regulatory pressures and safety concerns necessitate proactive compliance and transparent communication strategies.

  • Future growth relies on expanding into new geographies, developing differentiated formulations, and managing competitive pricing.

  • The projected financial trajectory indicates moderate growth, with potential for acceleration through strategic initiatives.


FAQs

1. How is the regulatory landscape affecting NUPRIN’s market?
Stringent safety regulations, especially concerning hepatotoxicity, have led to tighter dosing guidelines and increased consumer warnings. While these measures temporarily impact sales, proactive compliance and the development of safer formulations can preserve market presence.

2. What role do emerging markets play in NUPRIN’s growth?
Emerging markets like China and India offer substantial growth opportunities due to expanding healthcare access and consumer affordability. These regions are expected to contribute significantly to NUPRIN’s future revenue expansion.

3. How will competition from generics influence NUPRIN’s profitability?
The proliferation of low-cost generics exerts downward pressure on prices, necessitating differentiation via formulation innovations, branding, and strategic pricing to sustain profitability.

4. Are there any upcoming innovations that could impact NUPRIN’s market?
Innovations such as extended-release formulations, combination therapies, and improved safety profiles are in development, which could enhance NUPRIN’s appeal and market share if effectively commercialized.

5. What is the long-term outlook for NUPRIN amidst evolving analgesic therapies?
While the core market for acetaminophen faces challenges from alternative pain management therapies, NUPRIN’s entrenched position, coupled with ongoing innovation and safety management, suggests a resilient outlook with potential for steady growth.


Sources

[1] MarketWatch, “Global Analgesics Market Size and Forecast,” 2022.

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