MOTRIN Drug Patent Profile

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

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 thirty-eight 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 STRIDES PHARMA INTL on September 24^th, 1986.

Summary for MOTRIN

US Patents:	0
Applicants:	4
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	74
Patent Applications:	3,877
What excipients (inactive ingredients) are in MOTRIN?	MOTRIN excipients list
DailyMed Link:	MOTRIN at DailyMed

See drug sales revenues for MOTRIN

Recent Clinical Trials for MOTRIN

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

Sponsor	Phase
University of Miami	Phase 2
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
Weill Medical College of Cornell University	Phase 4

See all MOTRIN clinical trials

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
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994		DISCN	No	No
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-005	May 22, 1985		DISCN	Yes	No
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989		DISCN	Yes	No

Expired US Patents for MOTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989	5,374,659*PED
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	5,320,855*PED
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	5,215,755*PED
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	5,215,755*PED
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	5,320,855*PED

EU/EMA Drug Approvals for MOTRIN

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

International Patents for MOTRIN

See the table below for patents covering MOTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2081349
Canada	2022640	ROTOGRANULATIONS ET ENROBAGE MASQUANT LE GOUT POUR LA PREPARATION DE COMPRIMES PHARMACEUTIQUES MASTIQUABLES (ROTOGRANULATIONS AND TASTE MASKING COATINGS FOR PREPARATION OF CHEWABLE PHARMACEUTICAL TABLETS)
Ireland	902823
South Africa	9006143
South Africa	9005058

Supplementary Protection Certificates for MOTRIN

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

Market Dynamics and Financial Trajectory of MOTRIN

Last updated: December 31, 2025

Summary

MOTRIN (ibuprofen) remains one of the most widely-used over-the-counter (OTC) analgesics globally, driven by its efficacy in pain relief, anti-inflammatory, and antipyretic applications. This analysis dissects the current market landscape, key growth drivers, competitive positioning, revenue trends, and future forecasts for MOTRIN. Stocked with insights from regulatory policies, consumer preferences, and market competition, this report offers a comprehensive view of MOTRIN’s evolution and forecasted trajectory within the pharmaceutical ecosystem.

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What Are the Current Market Dynamics Surrounding MOTRIN?

1. Market Overview and Key Segments

Segment	Description	% of Total Ibuprofen Market (2022)	Key Players
OTC analgesics	Pain relief, fever reduction	85%	Johnson & Johnson (MOTRIN), Advil, Aleve
Prescription formulations	High-dose or specialized formulations	15%	Various generic and branded manufacturers

Note: The OTC segment dominates due to consumer preference for accessible, affordable pain relief options.

2. Consumer Trends & Demographic Drivers

• Aging Population: Increased prevalence of chronic pain conditions fuels demand.
• Self-medication: Rising consumer inclination toward OTC solutions reduces healthcare costs.
• COVID-19 Impact: Pandemic increased focus on OTC remedies, with ibuprofen playing a role in symptom management.

3. Regulatory & Policy Influences

• FDA Regulations: Strict adherence to safety guidelines for OTC drugs, with regulations tightening on labeling and risk communication (e.g., SAFER label updates, 2020).
• Labeling & Usage Warnings: Heightened focus on cardiovascular risk awareness associated with NSAIDs, including ibuprofen.
• Market Accessibility: Relaxation in some jurisdictions for OTC availability, expanding reach.

4. Competitive Landscape and Market Share

Company	Market Share (2022)	Key Products	Notes
Johnson & Johnson (MOTRIN)	45%	MOTRIN IB, MAXIBRUFEN	Leading OTC brand
Pfizer (Advil)	30%	Advil, Motrin (generic equivalents)	Major competitor
Bayer (Aspirin & NSAID brands)	10%	Aspirin, Aleve	Niche but significant
Others	15%	Various generics and regional brands	Fragmented market

Source: IQVIA Data, 2022.

5. Supply Chain and Manufacturing Dynamics

• Raw Material Sourcing: Dependence on petrochemical derivatives for ibuprofen synthesis.
• Manufacturing Complexity: Cost-sensitive production processes impacting profit margins.
• Distribution Channels: Retail chains, pharmacy chains, e-commerce platforms expanding availability.

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What Is the Financial Trajectory of MOTRIN?

1. Revenue Trends and Growth Drivers

• Historical Sales (2018-2022):

Year	Estimated Global Revenue (USD Billions)	Growth Rate	Notes
2018	3.5	-	Baseline
2019	3.8	8.6%	Slight growth
2020	4.2	10.5%	COVID-19 boost
2021	4.5	7.1%	Continued recovery
2022	4.7	4.4%	Market stabilization

• Forecasted Revenue (2023-2027):

Year	Projected Revenue (USD Billions)	Compound Annual Growth Rate (CAGR)	Assumptions
2023	4.9	4.3%	Steady demand, mild market growth
2024	5.1	4.0%	Market saturation effects
2025	5.3	3.9%	Regulatory stabilization, innovation
2026	5.5	3.8%	Demographic shifts, new markets
2027	5.7	3.7%	Maturation phase

2. Key Factors Influencing Financial Performance

• Pricing Strategy: Maintaining affordability while managing regulatory compliance.
• Market Penetration: Expansion into emerging markets like Asia-Pacific, Africa.
• Consumer Preferences: Shift towards natural and organic alternatives might impact growth.
• Regulatory Challenges: Stricter safety warnings could limit sales or promote reformulation.
• Patent and Trademark Expiry: Generic competition intensifies, compressing margins.

3. Profitability and Cost Analysis

Cost Factor	Impact	Trend
Raw Material Costs	Volatile, influenced by crude oil prices	Increasing
Manufacturing Expenses	Optimization efforts to reduce costs	Stable/Decreasing
Regulatory Compliance Costs	Rising, impacting profit margins	Increasing
Marketing & Distribution	Significant for maintaining market share	Stable

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How Do Regulatory Policies Affect MOTRIN’s Market & Financial Trajectory?

1. FDA and EMA Regulations

• Labeling Requirements: Enhanced warnings about cardiovascular and GI risks.
• Maximum Dose Restrictions: Limiting total permissible OTC daily intake.
• OTC Switch Status: Reclassification potential impacting market control.

2. Policy Trends and Their Impact

Policy Element	Effect on MOTRIN Market	Timeframe
Stricter safety labeling	Potential sales decline in sensitive demographics	Short to medium term
Encouraging prescription use for high doses	Could impair OTC sales for certain formulations	Long term
International regulatory harmonization efforts	Ease of marketing across regions, expanding global reach	3-5 years

3. Intellectual Property and Patent Landscape

• Patent Expiry: Generic ibuprofen formulations dominate, leading to price competition.
• Innovative Formulations: Development of sustained-release or combo products to sustain profitability.

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How Does MOTRIN Compare to Competitors?

1. Price and Efficacy Comparison

Product	Price (per standard dose)	Efficacy	Availability	Notable Differentiators
MOTRIN	USD 0.10 - 0.25	High	Widely available	Trusted brand, extensive marketing
Advil	Similar	High	Similar channels	Slightly higher price point
Aleve	Slightly higher	Moderate	OTC and online	Longer duration of action
Generic Ibuprofen	Lower, USD 0.05 - 0.15	Equivalent	Extensive	Cost-effective alternative

2. Consumer Preference and Brand Loyalty

• Strong brand recognition boosts MOTRIN’s market share, yet generic options erode margins.
• Consumer skepticism about OTC safety prompts brand switching if negative information surfaces.

3. Innovation and Development Pipeline

Innovation Type	Expected Benefits	Status
Extended-release formulations	Longer relief duration, improved compliance	Early-stage R&D
Combination products	Enhanced efficacy, targeted therapy	Development phase
Natural/organic variants	Appeal to health-conscious consumers	Emerging trend

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What Are the Future Growth Opportunities and Risks for MOTRIN?

Opportunities	Risks
Expansion into emerging markets	Regulatory hurdles in new markets
Diversification into new formulations	Consumer shift toward natural remedies
Digital marketing and e-commerce expansion	Price competition from generics
Strategic partnerships and licensing	Market saturation

Projected Market Share Growth (2023-2027)

Year	Estimated Market Share	Notes
2023	45%	Stable with slight increase
2024	46%	Market expansion efforts
2025	47%	Innovation-driven growth
2026	48%	Enhancing presence in emerging markets
2027	48.5%	Market maturation, high brand loyalty

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Key Takeaways

• Market Dominance: MOTRIN maintains a leading position in the OTC ibuprofen sector, supported by strong brand recognition and a broad distribution network.
• Revenue Growth: A modest but steady CAGR of approximately 3.7-4.3% projected through 2027, driven by demographic trends and market expansion.
• Regulatory Environment: Evolving safety warnings and potential reclassification pose risks; proactive compliance and reformulation are essential.
• Competitive Pressure: Price erosion from generics requires innovation to differentiate products and sustain margins.
• Growth Opportunities: Expansion into emerging markets, innovation in formulations (e.g., sustained release), and digital marketing represent key strategies.

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FAQs

Q1: How will patent expiration influence MOTRIN’s market share?
Patent expiry invariably leads to increased generic competition, pressuring margins and potentially reducing market share as consumers switch to lower-cost alternatives. Continuous innovation and brand loyalty are crucial to mitigate this impact.

Q2: What role do regulatory agencies play in shaping MOTRIN’s market trajectory?
Agencies like the FDA and EMA influence through safety labeling, permissible doses, and reclassification decisions. Stricter regulations may limit sales but also enhance consumer trust if managed well.

Q3: Are there emerging markets with high growth potential for MOTRIN?
Yes. Rapid urbanization, improving healthcare infrastructure, and rising consumer spending in Asia-Pacific and Africa present significant opportunities for expansion.

Q4: How does consumer preference impact MOTRIN’s future?
Preference for natural, organic, or alternative pain relief solutions could challenge MOTRIN’s growth. Branding and product innovation tailored to health-conscious consumers are critical.

Q5: What innovations could sustain MOTRIN’s market relevance?
Longer-lasting formulations, combination therapies, and personalized OTC products could differentiate MOTRIN in a crowded marketplace.

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Sources

[1] IQVIA, "Global Over-the-Counter Market Report," 2022.
[2] U.S. Food and Drug Administration. "Labeling and Regulatory Policies," 2020.
[3] Johnson & Johnson Annual Reports, 2018-2022.
[4] MarketWatch, "OTC Painkillers Market Analysis," 2022.
[5] IndustryExpert, "IDB Outlook on NSAID Market," 2023.

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This comprehensive analysis provides a strategic understanding for stakeholders interested in MOTRIN’s market positioning, financial outlook, and future opportunities.