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Last Updated: March 19, 2026

MOTRIN Drug Patent Profile


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Which patents cover Motrin, and when can generic versions of Motrin launch?

Motrin is a drug marketed by Mcneil, Mcneil Consumer, Mcneil Ped, and Kenvue Brands. and is included in six NDAs.

The generic ingredient in MOTRIN 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 Motrin

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

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Summary for MOTRIN
US Patents:0
Applicants:4
NDAs:6
Paragraph IV (Patent) Challenges for MOTRIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MOTRIN Intravenous ibuprofen 1000 mg/50 mL 2000 mg/100 mL 020418 2 2025-08-26

US Patents and Regulatory Information for MOTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil MOTRIN ibuprofen SUSPENSION/DROPS;ORAL 020476-001 May 25, 1995 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mcneil Consumer MOTRIN ibuprofen TABLET;ORAL 017463-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 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

Supplementary Protection Certificates for MOTRIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781277 PA2024501 Lithuania ⤷  Get Started Free PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

MOTRIN: PATENT LANDSCAPE AND INVESTMENT FUNDAMENTALS

Last updated: February 19, 2026

Motrin, a non-steroidal anti-inflammatory drug (NSAID) containing ibuprofen, faces a mature patent landscape characterized by expired foundational patents and ongoing, albeit limited, innovation in formulation and delivery. This analysis assesses the current intellectual property (IP) status, market position, and investment outlook for Motrin.

WHAT IS THE CURRENT PATENT STATUS OF IBUPROFEN?

The primary patent covering the composition of matter for ibuprofen (U.S. Patent No. 3,385,881) expired in 1985 [1]. This expiration opened the market to generic competition, significantly reducing the pricing power of branded Motrin. Subsequent patents have focused on specific salt forms, polymorphs, manufacturing processes, and novel formulations. However, these later-generation patents offer incremental protection rather than a broad shield against generic entry for the core active pharmaceutical ingredient (API).

Patent Type Key Characteristics Expiration Year (Approximate) Impact on Motrin
Composition of Matter Original ibuprofen molecule 1985 Fully expired; allows generic production of API
Process Patents Novel synthesis methods Varies (post-1985) Can provide manufacturing advantages; limited market entry barrier
Polymorphs/Salt Forms Specific crystalline structures or salts of ibuprofen Varies (post-1985) May offer improved stability or bioavailability; niche protection
Formulation Patents Extended-release, topical, pediatric formulations Varies (post-1985) Extends product lifecycle, creates differentiated offerings
Manufacturing Improvements Specific methods for purification or large-scale synthesis Varies (post-1985) Potential cost savings; competitive operational advantage

The absence of a valid composition of matter patent for ibuprofen is the primary driver of market dynamics. This allows any manufacturer to produce and sell generic ibuprofen, provided they comply with regulatory standards.

HOW HAS MOTRIN'S MARKET POSITION EVOLVED?

Motrin's market position has transitioned from a branded leader to a significant player within a highly competitive over-the-counter (OTC) NSAID market. The brand retains strong consumer recognition and trust, a legacy of its long-standing presence. However, the ubiquity of generic ibuprofen means that price is a critical competitive factor.

The competitive landscape includes:

  • Direct Competitors: Other ibuprofen brands (e.g., Advil), naproxen sodium brands (e.g., Aleve), and other generic ibuprofen products.
  • Indirect Competitors: Acetaminophen products (e.g., Tylenol) which, while not NSAIDs, compete for the pain relief market.
  • Private Label Brands: Retailer-owned brands that often offer ibuprofen at a lower price point.

The brand equity of Motrin is a key asset. Consumers often select brands they recognize and trust, especially for OTC medications. This allows Motrin to command a premium over generic equivalents, albeit a diminishing one.

Key market considerations:

  • Market Share: While precise, up-to-the-minute market share data for individual OTC brands is proprietary, ibuprofen as a class holds a substantial portion of the global pain relief market.
  • Sales Volume: Sales are driven by both direct consumer purchases and institutional use (e.g., healthcare providers, pharmacies).
  • Pricing: Motrin's pricing is influenced by competitive pressures from generics and private labels. The gap between branded Motrin and generic ibuprofen has narrowed over time.
  • Distribution Channels: Motrin is widely available through pharmacies, supermarkets, mass merchandisers, and online retailers.

WHAT ARE THE GROWTH DRIVERS AND REVENUE STREAMS FOR MOTRIN?

Growth drivers for Motrin are primarily linked to its established brand, its position in the large and stable pain relief market, and its availability in various formulations.

Primary revenue streams originate from:

  • Branded OTC Sales: Direct consumer purchases of Motrin products in various dosage strengths and forms.
  • Prescription Ibuprofen: While less common than OTC, some prescription-strength ibuprofen formulations may exist, contributing to revenue for the brand owner.
  • Specialty Formulations: Products like Motrin PM (ibuprofen with diphenhydramine) or extended-release versions can offer higher margins and capture specific market segments.
  • International Markets: While this analysis focuses on the U.S. context, global sales contribute to overall revenue.

Growth is challenged by the inherent commoditization of the core API due to patent expiries. Therefore, strategies to drive growth often involve:

  • Product Line Extensions: Introducing new formulations to address specific needs (e.g., children's formulations with improved taste, topical pain relief gels).
  • Marketing and Brand Reinforcement: Sustained advertising and promotional efforts to maintain brand awareness and preference.
  • Price Optimization: Balancing competitive pricing with brand value to maximize revenue.
  • Supply Chain Efficiency: Reducing manufacturing and distribution costs to improve margins.

WHAT ARE THE RISKS AND CHALLENGES FACING MOTRIN?

The primary risks and challenges for Motrin are directly tied to its product lifecycle and market structure.

Risks:

  • Intense Generic Competition: The expiration of foundational patents allows numerous generic manufacturers to produce ibuprofen, driving down prices. This is the most significant risk.
  • Price Erosion: Continuous downward pressure on pricing from generics and private labels limits profit margins for branded products.
  • Regulatory Scrutiny: NSAIDs, including ibuprofen, are subject to ongoing safety reviews and potential label changes regarding cardiovascular risks, gastrointestinal bleeding, and kidney issues. Such changes can impact consumer perception and sales.
  • Therapeutic Alternatives: Development of new pain relief medications or therapies, including non-pharmacological approaches, could divert market share.
  • Supply Chain Disruptions: Global events can impact the availability and cost of raw materials and manufacturing.

Challenges:

  • Maintaining Brand Differentiation: In a crowded market, convincing consumers to pay a premium for Motrin over generics requires robust branding and perceived quality advantages.
  • Innovation Limitations: The opportunity for groundbreaking IP in a well-established molecule like ibuprofen is limited. Future innovation often focuses on incremental improvements in formulation or delivery.
  • Consumer Education: Educating consumers on the proper use and potential risks of NSAIDs is an ongoing challenge for all brands in this class.
  • Retailer Power: Large retail chains exert significant influence on OTC pricing and product placement.

The long-term viability and growth of Motrin depend on its ability to navigate these risks through effective brand management, targeted innovation, and operational efficiency.

WHAT IS THE INVESTMENT OUTLOOK FOR MOTRIN?

The investment outlook for Motrin is that of a mature, established brand within a highly competitive and price-sensitive market. As a product whose core IP has long expired, significant growth driven by novel patent protection is unlikely.

Investment Thesis Considerations:

  • Stable Cash Flow: Motrin's brand recognition and broad market penetration suggest a consistent, albeit not rapidly growing, revenue stream. This can be attractive for income-focused investors.
  • Low R&D Intensity (for API): The lack of a need for extensive API patent prosecution reduces R&D expenditure related to the core molecule. Focus shifts to formulation innovation and marketing.
  • Market Dominance as a "Brand of Choice": While generics are prevalent, Motrin's brand equity provides a defensible niche and a premium price point compared to unbranded or lesser-known generics.
  • Acquisition Potential: Companies with strong OTC portfolios might view Motrin as an accretive acquisition to expand their pain relief offerings, especially if it can be integrated with existing manufacturing or distribution.
  • Limited Upside for Significant Capital Appreciation: Investors seeking high-growth opportunities driven by disruptive innovation or strong patent exclusivity may find Motrin less appealing. The investment thesis is more about stable returns and market defense.

Valuation Drivers:

  • Market Share Stability: Maintaining or slightly growing share against generics.
  • Brand Equity: The value of consumer trust and recognition.
  • Cost of Goods Sold (COGS): Efficiency in manufacturing and supply chain management.
  • Marketing Effectiveness: ROI on advertising and promotional spend.
  • Pricing Power: The ability to maintain a price premium over generics.

Given the market dynamics, an investment in Motrin is best characterized as a play on a well-established consumer staple within the pharmaceutical sector rather than a high-growth biotech venture. Its performance will likely be tied to overall consumer spending, healthcare trends, and the ability of its owner to manage costs and maintain brand loyalty.

KEY TAKEAWAYS

  • Motrin's foundational composition of matter patent expired in 1985, leading to widespread generic competition.
  • Subsequent patents cover specific formulations, processes, and forms, offering incremental rather than comprehensive market exclusivity.
  • The brand retains strong consumer recognition, enabling a price premium over generics, but this premium is under constant pressure.
  • Revenue is driven by OTC sales, with growth relying on product line extensions, marketing, and operational efficiency.
  • Key risks include intense generic competition, price erosion, and regulatory scrutiny of NSAIDs.
  • The investment outlook is for stable cash flow from a mature brand rather than high growth, making it suitable for income-focused investors or strategic acquisitions.

FAQS

  1. Can new patents for ibuprofen still be obtained, and how would they impact Motrin? New patents can be obtained for novel formulations (e.g., improved delivery systems, combination therapies), specific polymorphs with advantageous properties, or advanced manufacturing processes. Such patents could provide limited market exclusivity for a specific product iteration, potentially extending the brand's lifecycle for that particular offering, but they would not protect the core ibuprofen molecule from generic competition.

  2. What is the typical lifespan of an OTC drug brand like Motrin after its primary patents expire? OTC brands with strong brand recognition and effective marketing can maintain market presence for decades after patent expiry. Their lifespan is dictated by brand loyalty, the introduction of superior therapeutic alternatives, and the brand owner's ability to manage costs and differentiate products through formulation and marketing.

  3. How does Motrin's market performance compare to other major OTC pain relievers like acetaminophen or naproxen? Ibuprofen (Motrin, Advil) and acetaminophen (Tylenol) are the two largest segments of the OTC pain relief market. Naproxen (Aleve) represents another significant NSAID segment. The performance comparison is complex and depends on specific product marketing, pricing strategies, and consumer preference for different drug mechanisms of action (NSAID vs. analgesic). All face intense generic competition.

  4. What are the regulatory hurdles for introducing new ibuprofen formulations or delivery systems? New formulations and delivery systems for OTC drugs require approval from regulatory bodies like the U.S. Food and Drug Administration (FDA). This involves demonstrating safety and efficacy, which includes rigorous testing, stability studies, and labeling compliance. For established drugs like ibuprofen, the focus is often on the formulation's performance and safety profile compared to existing options.

  5. What is the role of manufacturing cost and supply chain efficiency in the profitability of a post-patent drug like Motrin? For a drug with expired patents and significant generic competition, manufacturing cost and supply chain efficiency are critical profitability drivers. Lowering the cost of goods sold (COGS) allows the brand to maintain a healthier margin or to compete more aggressively on price. Efficient supply chains ensure consistent product availability, which is essential for customer retention.

CITATIONS

[1] U.S. Patent No. 3,385,881. (1968). 2-(4-Isobutylphenyl)propionic acid.

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