MOTRIN MIGRAINE PAIN Drug Patent Profile

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

Motrin Migraine Pain is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in MOTRIN MIGRAINE PAIN is ibuprofen. There is one drug master file entry for this compound. Two hundred and fifty-two suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Motrin Migraine Pain

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

Summary for MOTRIN MIGRAINE PAIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,989
DailyMed Link:	MOTRIN MIGRAINE PAIN at DailyMed

Recent Clinical Trials for MOTRIN MIGRAINE PAIN

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

Sponsor	Phase
Oregon Health and Science University	Phase 2/Phase 3

See all MOTRIN MIGRAINE PAIN clinical trials

Pharmacology for MOTRIN MIGRAINE PAIN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for MOTRIN MIGRAINE PAIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	MOTRIN MIGRAINE PAIN	ibuprofen	TABLET;ORAL	019012-004	Feb 25, 2000		DISCN	No	No

EU/EMA Drug Approvals for MOTRIN MIGRAINE PAIN

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

Motrin Migraine Pain Market Dynamics and Financial Trajectory

Last updated: October 19, 2026

Motrin Migraine Pain is an over-the-counter ibuprofen product positioned for temporary relief of migraine-associated pain. Its commercial outlook is driven by brand recognition, retail distribution, pricing, advertising, and competition from Advil Migraine, generic ibuprofen, acetaminophen products, and combination migraine medicines. Motrin’s active ingredient is mature, inexpensive, and widely available, so the product has limited patent protection and low regulatory barriers to substitution. Kenvue does not publicly report revenue or profit for Motrin Migraine Pain as a standalone product.

What is Motrin Migraine Pain?

Motrin Migraine Pain is an OTC oral analgesic product containing ibuprofen, a nonsteroidal anti-inflammatory drug. The product is marketed for temporary relief of minor aches and pains associated with migraine.

Attribute	Motrin Migraine Pain
Brand	Motrin
Active ingredient	Ibuprofen
Drug class	NSAID analgesic
Dosage form	Oral tablet or caplet, depending on package configuration
Regulatory category	OTC human drug
Primary use	Temporary relief of migraine-associated pain
Prescription required	No
U.S. patent exclusivity	No meaningful composition-of-matter exclusivity
Commercial owner	Kenvue brand portfolio
Standalone revenue disclosure	Not publicly reported

The product competes in the self-care pain market rather than the prescription migraine market. It does not compete directly on the same clinical basis as CGRP antagonists, triptans, or injectable migraine therapies.

Who owns Motrin Migraine Pain and how is it commercialized?

Kenvue owns the Motrin brand portfolio following its separation from Johnson & Johnson’s consumer-health business. Kenvue markets Motrin within its over-the-counter health-care portfolio, alongside Tylenol, Nicorette, Benadryl, Zyrtec, and other consumer brands.[1]

Motrin Migraine Pain is generally commercialized through:

• Mass retailers and pharmacies
• Grocery stores and club retailers
• E-commerce marketplaces
• Retail pharmacy chains
• Private-label and store-brand competitive channels

Brand-level economics depend on the retail price, promotional discounts, retailer allowances, manufacturing cost, and advertising expenditure. Kenvue reports financial performance by operating segment and brand group rather than by individual OTC SKU. Public filings therefore do not establish product-level sales, gross margin, market share, or operating profit for Motrin Migraine Pain.[1]

How large is the migraine pain market?

The relevant market has three overlapping segments:

1. Single-ingredient OTC analgesics, including ibuprofen, naproxen, and acetaminophen.
2. Combination migraine products, including analgesic and caffeine combinations.
3. Prescription migraine therapies, including triptans and CGRP-targeting medicines.

Motrin Migraine Pain competes primarily in the first segment, with some exposure to the second. Its addressable market is much larger than the migraine indication alone because consumers may purchase ibuprofen for headaches, dental pain, musculoskeletal pain, menstrual pain, fever, and other conditions.

The market is mature. Growth is normally generated by:

• Retail price increases
• Product-line extensions
• Premium packaging and larger pack sizes
• E-commerce expansion
• Increased migraine self-treatment
• Retailer distribution gains
• Advertising and promotional activity

Unit growth is constrained by generic substitution and the availability of lower-priced ibuprofen products.

How does Motrin Migraine Pain compare with Advil Migraine?

Motrin Migraine Pain and Advil Migraine are commercially similar because both rely on ibuprofen as the core analgesic ingredient. Advil is also owned by Kenvue, making the products part of the same corporate portfolio rather than independent competitors.

Factor	Motrin Migraine Pain	Advil Migraine
Active ingredient	Ibuprofen	Ibuprofen
Consumer positioning	Motrin brand migraine relief	Advil brand migraine relief
Regulatory pathway	OTC analgesic labeling	OTC analgesic labeling
Patent differentiation	Limited	Limited
Primary commercial advantage	Motrin brand equity and distribution	Advil brand equity and distribution
Likely substitution risk	Generic ibuprofen and store brands	Generic ibuprofen and store brands
Parent company	Kenvue	Kenvue

Kenvue can use portfolio segmentation to maintain shelf presence across different consumer preferences. The two brands can occupy different price points, retailer relationships, package sizes, or advertising positions. Their internal proximity also creates potential cannibalization risk if the products have substantially similar formulations and indications.

What patents protect Motrin Migraine Pain?

No meaningful active ingredient patent estate protects Motrin Migraine Pain. Ibuprofen has been marketed for decades, and the active ingredient is available from multiple manufacturers worldwide.

Potential intellectual-property protection may exist around:

• Package design
• Trademarks
• Brand names
• Trade dress
• Specific manufacturing processes
• Certain tablet coatings or excipient combinations
• Packaging configurations
• Marketing claims

Those rights are materially different from a pharmaceutical patent blocking generic entry. They generally do not prevent competitors from selling ibuprofen migraine products with the same active ingredient and comparable labeling.

The principal commercial rights are trademark rights in Motrin and related brand identifiers. Brand protection can support pricing and consumer loyalty, but it cannot prevent generic ibuprofen or competing branded products from entering the category.

When does Motrin Migraine Pain lose exclusivity?

Motrin Migraine Pain does not face a conventional patent-loss event comparable to a prescription drug losing composition-of-matter protection. The product is already in a mature OTC market with widespread generic competition.

Its effective exclusivity was limited by:

• The maturity of ibuprofen as an active ingredient
• Existing OTC monograph pathways
• Multiple generic ibuprofen manufacturers
• Store-brand substitution
• Competing national brands
• Retailer control over shelf placement and pricing

The relevant commercial question is not the date of patent expiration. It is whether Kenvue can preserve brand premiums despite equivalent low-cost alternatives.

What is the FDA regulatory status of Motrin Migraine Pain?

Ibuprofen products are regulated as OTC analgesic and antipyretic drugs. The FDA’s OTC framework establishes conditions for active ingredients, dosage, labeling, warnings, and permitted claims.[2]

For an ibuprofen migraine product, the key regulatory controls include:

• Active ingredient identity and strength
• Dosage instructions
• Maximum daily dose
• Age restrictions
• Warnings concerning stomach bleeding and cardiovascular risk
• Contraindications involving aspirin-sensitive asthma or NSAID reactions
• Pregnancy-related labeling
• Directions for use in migraine-associated pain

The FDA’s OTC Drug Facts requirements are central to commercialization. A change in indication, dosage, active ingredient, or formulation can require regulatory review or a different legal pathway.

Is Motrin Migraine Pain listed in the Orange Book?

The Orange Book primarily lists approved prescription drug products and certain approved nonprescription products associated with approved applications. A conventional OTC monograph product does not receive the same type of Orange Book patent-exclusivity profile as a prescription NDA product.[3]

Motrin Migraine Pain should therefore be analyzed primarily through:

• FDA OTC monograph compliance
• Product labeling
• National Drug Code records
• Kenvue trademark ownership
• Retail and consumer-health market data

An Orange Book Paragraph IV strategy is generally not the central entry mechanism for a conventional ibuprofen OTC product.

Are there Paragraph IV challenges or generic-launch risks?

A conventional Paragraph IV challenge is unlikely to be commercially relevant if the product is marketed under an OTC monograph pathway without blocking patents listed for the product. Generic and private-label competition is already present.

The principal launch risks are operational and commercial:

Risk	Impact
Store-brand ibuprofen	Direct price pressure
Generic drug availability	Limits brand premium
Retailer promotion	Can shift volume toward lower-priced alternatives
Ingredient cost increases	Compress gross margin
Supply disruption	Creates out-of-stocks and lost shelf position
Advertising weakness	Reduces consumer demand
Labeling changes	May increase compliance costs
Product recalls	Can affect the wider Motrin franchise

A competitor does not need to invalidate a patent to enter the market. It can sell an equivalent ibuprofen product under the OTC regulatory framework.

What formulation patents protect Motrin Migraine Pain?

The product’s potential formulation protection is likely narrow and commercially secondary. Possible claims could cover tablet hardness, coating, dissolution characteristics, excipients, or packaging. Those features may improve manufacturing or consumer experience, but they generally do not create durable market exclusivity for ibuprofen.

The most important formulation-related barriers are practical rather than legal:

• Manufacturing scale
• Quality-control systems
• FDA-compliant labeling
• Retail qualification
• National distribution
• Inventory availability
• Consumer trust

Because ibuprofen is widely manufactured, technical entry barriers are low relative to biologics, sterile injectables, or complex drug-delivery systems.

How strong is the Motrin Migraine Pain patent estate?

The patent estate is weak as a barrier to generic entry but the trademark estate is commercially meaningful.

Protection type	Relative strength	Commercial effect
Ibuprofen composition patent	None for modern market entry	No exclusion
Migraine-use patent	Limited or absent for OTC positioning	Minimal
Formulation patent	Potentially narrow	Product-specific protection
Manufacturing patent	Potentially narrow	Limited if alternatives exist
Motrin trademark	Strong if maintained	Supports brand recognition
Trade dress	Moderate	Helps shelf differentiation
Regulatory exclusivity	Limited for mature OTC product	No major barrier

Kenvue’s defensibility comes from brand scale, retailer access, marketing resources, and consumer familiarity. The company cannot rely on patent exclusivity to maintain pricing power.

What licensing deals affect Motrin Migraine Pain?

No major publicly disclosed third-party licensing transaction is required to commercialize the basic ibuprofen product. The commercial model is primarily vertically managed through Kenvue’s brand, supply-chain, regulatory, and distribution infrastructure.

Third-party relationships may exist in:

• Contract manufacturing
• Ingredient procurement
• Packaging
• Logistics
• Retail distribution
• Advertising and media

These arrangements are not generally disclosed at the individual-product level. No publicly reported licensing deal establishes a separate revenue-sharing right or external royalty burden specific to Motrin Migraine Pain.

What litigation affects Motrin Migraine Pain?

No material public patent litigation is central to the product’s market position. Litigation exposure is more likely to arise from:

• Product-liability claims involving NSAID risks
• Consumer-protection claims
• Advertising or labeling disputes
• Trademark conflicts
• Manufacturing and quality issues
• Recalls or regulatory enforcement

NSAID-related litigation can affect the broader Motrin franchise even when a claim concerns another dosage form or indication. The economic exposure is typically managed at the portfolio or corporate level rather than disclosed for an individual migraine SKU.

What is the financial trajectory for Motrin Migraine Pain?

A standalone financial trajectory cannot be derived from Kenvue’s public filings because the company does not report Motrin Migraine Pain revenue, volume, gross profit, or operating margin separately.[1]

The likely trajectory is that of a mature branded OTC product:

Financial driver	Expected effect
List-price increases	Supports nominal revenue
Unit demand	Generally stable or modestly variable
Generic substitution	Limits volume and price growth
Retailer bargaining power	Pressures net realization
Advertising investment	Protects brand demand
E-commerce	Expands access but increases price transparency
Input-cost inflation	Can reduce margin
Portfolio scale	Supports procurement and distribution efficiency
Innovation	Provides limited but useful premiumization opportunities

Revenue can rise even when unit demand is flat if Kenvue increases prices or shifts consumers toward larger packs. That growth may not translate into equivalent profit growth if retailer discounts, media spending, freight costs, or raw-material prices increase.

What generic launch scenarios exist?

Three scenarios are commercially relevant.

Base case: stable branded niche

Kenvue maintains distribution and brand recognition. Motrin Migraine Pain generates stable revenue with modest price-driven growth, while generic substitution caps unit expansion.

Downside case: accelerated private-label substitution

Retailers allocate more shelf space to store brands and lower-cost ibuprofen products. Kenvue responds with promotions, reducing net sales and gross margin.

Upside case: portfolio and channel expansion

Kenvue improves online conversion, increases migraine-specific advertising, expands pack architecture, or gains retail distribution. Revenue grows through improved visibility and pricing rather than patent protection.

How does Motrin Migraine Pain compare with prescription migraine drugs?

Motrin Migraine Pain has a lower price, broader availability, and no prescription requirement. Prescription products offer more targeted mechanisms and may be used when OTC analgesics are inadequate.

Factor	Motrin Migraine Pain	Prescription migraine therapy
Access	Immediate OTC purchase	Clinician and pharmacy access
Price per treatment	Low	Often materially higher
Patent protection	Minimal	Often substantial
Clinical positioning	Mild-to-moderate self-treated pain	Acute or preventive treatment
Reimbursement	Usually consumer-paid	May involve insurance
Generic risk	Already present	Often follows patent expiry
Manufacturing complexity	Low	Varies by product

The two categories can coexist. OTC products often serve early, intermittent, or lower-severity treatment, while prescription therapies capture patients requiring greater efficacy or preventive management.

Key Takeaways

• Motrin Migraine Pain is a mature OTC ibuprofen product marketed under Kenvue’s Motrin brand.
• The product has little or no meaningful active-ingredient patent protection.
• Generic and private-label competition is already established.
• Kenvue does not disclose standalone revenue or profit for Motrin Migraine Pain.
• Its commercial value depends on brand equity, retail distribution, pricing, advertising, and supply reliability.
• Paragraph IV litigation is unlikely to be the main entry issue.
• The principal legal assets are trademarks and trade dress, not pharmaceutical exclusivity.
• Financial growth is more likely to come from pricing, distribution, and portfolio management than unit expansion.
• The main downside risk is erosion of branded OTC premiums through retailer and generic substitution.
• The product’s economic trajectory should be evaluated through Kenvue’s broader self-care performance and external retail-scanner data, not public product-level financial statements.

FAQs

Does Motrin Migraine Pain contain the same active ingredient as regular Motrin?

Yes. Motrin migraine products use ibuprofen as the active analgesic ingredient, subject to the specific product label and package configuration.

Can a generic manufacturer sell an equivalent Motrin migraine product?

Yes. Competitors can market ibuprofen migraine products under applicable FDA OTC requirements without acquiring a license from Kenvue.

Is Motrin Migraine Pain protected by an active pharmaceutical patent?

No meaningful modern market exclusivity is expected from the ibuprofen active ingredient. Any remaining protection would more likely involve trademarks, packaging, or narrow product-specific formulation claims.

Does Kenvue report Motrin Migraine Pain sales separately?

No. Kenvue reports financial information at broader operating-segment and brand-portfolio levels rather than for this individual SKU.

What is the main investment risk for the product?

The main risk is branded OTC margin erosion caused by generic ibuprofen, private-label products, retailer promotions, input-cost inflation, and declining consumer willingness to pay a premium for branded analgesics.

References

1. Kenvue Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
2. U.S. Food and Drug Administration. (n.d.). OTC monograph M012: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.