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 seven NDAs.

The generic ingredient in MOTRIN is ibuprofen. There is one drug master file entry for this compound. Two hundred and fifty 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 15^th, 1986.

Summary for MOTRIN

US Patents:	0
Applicants:	4
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	74
Patent Applications:	3,982
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
Kenvue Brands	MOTRIN MIGRAINE PAIN	ibuprofen	TABLET;ORAL	019012-004	Feb 25, 2000		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

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
Austria	110259
Australia	5792690
Australia	635283
Canada	2019863	SUSPENSION AQUEUSE PHARMACEUTIQUE POUR DES INGREDIENTS ACTIFS PHARMACEUTIQUES PEU HYDROSOLUBLES (AQUEOUS PHARMACEUTICAL SUSPENSION FOR SUBSTANTIALLY WATER INSOLUBLE PHARMACEUTICAL ACTIVES)
Germany	69011766
European Patent Office	0405930	Suspension pharmaceutique aqueuse pour des agents actifs pharmaceutiques essentiellement insolubles dans l'eau. (Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives.)

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

Last updated: April 25, 2026

MOTRIN: Market Dynamics and Financial Trajectory

Motrin is the brand name for ibuprofen in the US and multiple markets. Its market dynamics are dominated by (1) OTC availability, (2) high generic penetration, and (3) continuous demand for NSAID self-care. Financial trajectory for “Motrin” specifically is best understood as a function of brand share versus generic price pressure, with periodic strength from new formulations and channel mix (OTC vs prescription legacy) rather than patent exclusivity.

Because “Motrin” is not a single patented asset today, the financial story is not a clean one-shot licensing or pipeline curve; it is a long-running, price-competitive consumer product governed by category-level growth and share.

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What drives Motrin’s market dynamics?

1) Is the product in a protected market or open competition?

Motrin is commercially active in an open competitive landscape. Ibuprofen’s key patents have long expired in major jurisdictions, and the brand operates in a market with extensive lower-priced generics.

Implication for pricing and margins

• List price to consumers usually stays stable for brand OTC products due to retail pricing architecture, but net pricing declines under generic promotions and private-label competition.
• Margin stability depends on formulation differentiation (e.g., strength, dosing convenience, targeted sub-brands) and contracting terms with pharmacy and retail channels.

2) How does the OTC category shape demand?

Demand is anchored to chronic and acute self-care use cases for NSAIDs:

• Pain relief (headache, muscle/joint aches)
• Fever reduction
• Inflammation-related discomfort

Category cycles tend to track:

• Seasonality (headache and cold/flu seasons lift demand)
• Consumer health trends (preference for OTC self-management)
• Retail promo intensity (holiday and back-to-school periods)

3) What are the key channels?

Motrin’s sales mix is determined by retail structure:

• Drug stores and mass retail
• Club and e-commerce
• Direct pharmacy channels via distributors

Channel shifts influence financial trajectory more than innovation does, because the product is substitutable with generics and store brands.

4) How do formulation and pack strategies affect share?

In OTC NSAIDs, “brand advantage” often comes from:

• Pack architecture (count and value packs)
• Strength positioning (mg per tablet/caplet; pediatric and adult lines)
• Dosing frequency claims that align with consumer preference

This creates short windows where brand share improves even in a structurally commoditized market.

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What does Motrin’s competitive pricing look like versus generics?

Competitive baseline

• Generic ibuprofen has multiple SKUs across strengths and dosage forms.
• Brand pricing typically remains above generics, but demand is sensitive to:
  • price gaps (dollar difference)
  • promo cadence
  • pharmacy shelf positioning
  • online discounting

Market mechanism

Brand sales tend to follow a “share offset” pattern:

• When the brand price gap widens, consumers trade down.
• When the brand offers promo-led value (or when retailers highlight the brand), share can hold up.

This is why Motrin’s financial trajectory is more volatile around promo periods and retailer resets than around clinical or scientific milestones.

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How has the regulatory and labeling environment influenced Motrin?

OTC NSAIDs operate under tightly governed labeling rules (indications, warnings, and dosing limits). Changes in:

• risk communications
• contraindications
• age and dosing guidance (especially pediatric)

can affect conversion rates at the shelf and in digital search, and force reformulation or labeling updates across SKUs. These events typically do not eliminate the product, but they influence demand.

Business impact

• Higher compliance and update costs
• Potential short-term disruption in marketing effectiveness
• Sustained demand if label changes are broadly consistent with consumer expectations

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What is the financial trajectory logic for Motrin?

Trajectory drivers that determine up or down years

Motrin’s financial trajectory is shaped by four recurring levers:

1. Share versus generic ibuprofen
   • Core determinant when overall category demand is flat.
2. Net price after trade spend
   • Strongly influenced by retail promotions and wholesaler contracting.
3. Mix
   • Favorable mix includes higher strength SKUs, value packs, and online share.
4. Portfolio depth and line extensions
   • New or refreshed formulations can stabilize or lift brand share, even if the molecule is unchanged.

Typical pattern in commoditized OTC categories

• Volume stability tends to hold through category demand.
• Revenue growth is harder to sustain without share gains because unit prices compress versus generics.
• Operating profit depends on how well the brand manages:
  • marketing intensity
  • trade spend
  • logistics costs
  • promotional ROI

Where growth usually comes from

For Motrin, growth typically comes from:

• winning incremental share through promotions and shelf strategy
• increasing strength or convenience SKUs within the OTC NSAID basket
• retaining consumers through “total brand experience” (pack format and dosing experience)

Where headwinds come from

Headwinds typically come from:

• generic price resets
• private-label expansion
• retailer merchandising changes that privilege lower price tiers

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What do industry economics imply for ibuprofen brands like Motrin?

In mature OTC NSAID markets:

• Category growth is usually modest.
• Brand outcomes track share and net price.
• Marketing and trade spend rise when competition intensifies.

That makes Motrin’s performance less like a blockbuster and more like a mature consumer brand:

• stable baseline volumes
• periodic revenue pressure from price competition
• occasional improvement when mix shifts or promo strategy lifts share

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What are the main business decisions that affect Motrin’s next 12 to 36 months?

1) Retail and e-commerce promo strategy

• Adjusting promo frequency and depth is the fastest way to affect short-term share.
• Online price competition can compress net revenue even when volume rises.

2) Portfolio SKU management

• Rationalize low-performing pack counts.
• Push SKUs where differentiation (strength, dosing convenience, pediatric/target segments) holds better.

3) Marketing spend allocation

• Optimize spend to retain brand-specific conversion in search and pharmacy environments.
• Measure incremental lift versus trade-driven cannibalization.

4) Compliance-driven label and formulation updates

• Keep packaging and labeling aligned with current NSAID OTC expectations.
• Avoid supply disruptions from refresh cycles, especially when warnings or dosing language changes.

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Key Takeaways

• Motrin’s market dynamics are driven by OTC ibuprofen substitutability, generic and private-label competition, and retail promo cycles.
• Financial trajectory follows a mature OTC pattern: volume stability with revenue pressure from net price compression, offset by share gains and mix from differentiated SKUs and pack strategies.
• Near-term financial outcomes depend more on channel contracting, promotional intensity, and SKU portfolio choices than on molecule-level innovation.

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FAQs

1) Is Motrin protected from generic competition?

No. It operates in a market with extensive generic ibuprofen availability, so performance depends on share and net pricing rather than exclusivity.

2) What most directly impacts Motrin revenue growth?

Net price after trade spend and brand share versus generics, both heavily influenced by retail promotion intensity.

3) Does seasonality matter for Motrin?

Yes. Demand typically rises in periods with higher illness-related pain/fever episodes and seasonal consumer traffic.

4) What portfolio actions can lift Motrin results without a new molecule?

Pack and formulation strategies that improve convenience, strength targeting, and differentiation within OTC NSAID segments.

5) Where can Motrin see margin improvement in a commodity category?

From improving net pricing, reducing unproductive trade spend, and optimizing SKU mix and supply-chain efficiency.

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References

[1] U.S. Food and Drug Administration. (n.d.). OTC drug facts and ibuprofen labeling information. FDA. https://www.fda.gov/
[2] DailyMed. (n.d.). Motrin (ibuprofen) drug label and prescribing/OTC information. National Library of Medicine. https://dailymed.nlm.nih.gov/
[3] European Medicines Agency. (n.d.). Ibuprofen product information and regulatory framework for NSAIDs in the EU. EMA. https://www.ema.europa.eu/