When will the ALEVE PM patents expire, and when will ALEVE PM go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ALEVE PM	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	205352-001	Jan 17, 2014		OTC	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 24, 2026

Aleve PM is an over-the-counter combination of naproxen sodium and diphenhydramine hydrochloride marketed in the United States by Bayer Consumer Health. The product combines long-acting NSAID pain relief with a sedating antihistamine for nighttime use. Its commercial position is supported primarily by Aleve brand recognition, retail distribution, and consumer familiarity rather than by patent exclusivity.

Product-specific revenue is not publicly disclosed. Bayer reports consumer-health performance at broader portfolio and regional levels, so Aleve PM’s financial trajectory must be inferred from the U.S. OTC analgesic and nighttime pain-relief categories, brand activity, pricing, distribution, and competitive intensity.

What is Aleve PM and how does the product work?

Aleve PM contains two active ingredients:

Component	Typical strength per caplet	Function
Naproxen sodium	220 mg	NSAID analgesic and fever reducer
Diphenhydramine hydrochloride	25 mg	Sedating antihistamine used as a nighttime sleep aid

The labeled consumer use is temporary relief of minor aches and pains with nighttime relief of occasional sleeplessness associated with those aches and pains. Naproxen sodium provides longer-duration analgesia than many short-acting OTC alternatives. Diphenhydramine creates the nighttime positioning but also introduces sedation, next-day impairment, anticholinergic effects, and age-related safety concerns. [1]

Aleve PM competes in a hybrid category rather than a single therapeutic segment. It draws demand from:

OTC oral analgesics
nighttime pain relievers
sleep-aid products
branded NSAIDs
private-label combination medicines

The product is intended for occasional use. That limits chronic-use potential but supports premium pricing relative to single-ingredient generic naproxen sodium.

What is the FDA regulatory status of Aleve PM?

Aleve PM is an OTC drug product. It is regulated under the FDA’s OTC framework for analgesic, antipyretic, and external analgesic products, together with the regulatory framework for nighttime sleep-aid products containing diphenhydramine. The product is not a biologic and does not require biosimilar approval.

The principal regulatory controls are labeling, active-ingredient strength, dosage instructions, warnings, packaging, manufacturing controls, and compliance with applicable OTC monograph requirements. The FDA’s final OTC monograph system under the CARES Act replaced the former monograph rulemaking process with administrative orders. [2]

Key regulatory issues

The product’s label must address risks associated with both active ingredients. Naproxen sodium labeling includes warnings related to stomach bleeding, cardiovascular events, allergic reactions, kidney effects, and use during pregnancy. Diphenhydramine labeling includes warnings on drowsiness, alcohol and sedative use, driving, and use by older adults.

A combination product must also prevent consumers from unintentionally duplicating ingredients through simultaneous use of:

Aleve or generic naproxen products
Advil PM or other ibuprofen products
Tylenol PM or other diphenhydramine-containing products
standalone sleep aids
prescription or nonprescription sedatives

What patents protect Aleve PM?

Aleve PM does not appear to have a commercially significant, currently enforceable patent barrier comparable to those protecting a new prescription drug. Its active ingredients are longstanding, well-established compounds:

Naproxen sodium is an established NSAID.
Diphenhydramine is an established antihistamine and sleep-aid ingredient.
The combination is based on known OTC active ingredients.

Aleve PM’s commercial protection is therefore based on brand equity, shelf placement, packaging, retailer relationships, advertising, and consumer recognition. Trademark rights can remain commercially relevant after patents expire, but trademarks do not prevent lawful sale of equivalent generic combinations under different names.

Does Aleve PM have Orange Book protection?

Aleve PM is not generally treated as an Orange Book-protected prescription product. The FDA Orange Book primarily supports therapeutic-equivalence determinations for approved prescription and certain OTC products submitted through an NDA pathway. A conventional OTC monograph product does not create the same Orange Book patent-certification structure as a prescription NDA product.

As a result:

Exclusivity mechanism	Aleve PM position
New chemical entity exclusivity	None
Prescription NDA exclusivity	Not the primary regulatory basis
Orphan exclusivity	None
Biologic exclusivity	Not applicable
Standard Orange Book patent challenge	Generally not applicable
OTC monograph compliance	Primary regulatory pathway
Trademark and trade dress	Commercially relevant
Formulation or packaging patents	No material public barrier identified

When does Aleve PM lose exclusivity?

Aleve PM has no identifiable near-term loss-of-exclusivity event comparable to a prescription drug patent expiration. The active ingredients have long been available in generic form, and competing manufacturers can market naproxen-diphenhydramine products if they comply with the applicable OTC requirements.

The practical answer is that Aleve PM’s product-level exclusivity has already expired in economic terms. The brand remains differentiated through:

The Aleve trademark.
Bayer’s distribution and retail relationships.
Consumer trust in the Aleve brand.
Packaging and merchandising.
Advertising and promotional spending.
Retailer willingness to give the brand shelf space.

Are there Paragraph IV challenges to Aleve PM?

No material Paragraph IV litigation risk is associated with the standard OTC Aleve PM product. Paragraph IV certifications apply principally to abbreviated applications referencing patents listed for an FDA-approved reference drug. A monograph-based OTC competitor generally does not need to challenge Aleve PM patents through the ANDA Paragraph IV process.

A competitor could still enter through:

An OTC monograph-compliant product.
A private-label product manufactured by an established OTC supplier.
An NDA or other FDA submission if the product falls outside the applicable monograph framework.
A different combination or dosage form supported by its own regulatory basis.

How large is the market for Aleve PM?

Aleve PM operates in a mature, highly competitive U.S. OTC market. The most relevant demand pools are oral analgesics and nighttime analgesic products. Public market reports often combine branded and private-label products across several categories, making exact Aleve PM sales difficult to isolate.

The commercial market has several structural characteristics:

Market factor	Effect on Aleve PM
Mature NSAID category	Limits volume growth
Strong brand recognition	Supports price premium
Retailer private label	Compresses pricing
High household penetration	Supports repeat purchase
Low switching costs	Increases promotional sensitivity
E-commerce growth	Improves product availability
Safety scrutiny of NSAIDs	Creates regulatory and demand risk
Sleep-aid competition	Expands substitution options

The product’s principal advantage is convenience. Consumers can purchase one caplet intended for nighttime pain and sleep support rather than combining separate medicines. Its main commercial weakness is that the same combination raises safety concerns and limits appropriate use for some consumers.

How does Aleve PM compare with competing nighttime pain relievers?

Aleve PM versus Advil PM

Advil PM combines ibuprofen and diphenhydramine. Aleve PM uses naproxen sodium instead of ibuprofen.

Attribute	Aleve PM	Advil PM
NSAID	Naproxen sodium	Ibuprofen
Sleep-aid ingredient	Diphenhydramine	Diphenhydramine
Brand owner	Bayer	Haleon
Positioning	Nighttime pain relief	Nighttime pain relief
Consumer distinction	Longer-acting Aleve brand association	Advil brand association and broad ibuprofen use
Main risk	NSAID and sedating-antihistamine risks	NSAID and sedating-antihistamine risks

The products are close substitutes. Aleve PM may appeal to consumers seeking longer-lasting relief, while Advil PM benefits from the scale of the Advil brand and ibuprofen’s broad consumer familiarity.

Aleve PM versus Tylenol PM

Tylenol PM combines acetaminophen and diphenhydramine. It competes directly for nighttime pain-relief occasions but is not an NSAID.

Attribute	Aleve PM	Tylenol PM
Analgesic	Naproxen sodium	Acetaminophen
Anti-inflammatory activity	Yes	No
Sleep-aid ingredient	Diphenhydramine	Diphenhydramine
Key safety issue	NSAID gastrointestinal, cardiovascular, renal risks	Acetaminophen liver toxicity risk at excessive doses
Consumer positioning	Pain with inflammation and nighttime use	General nighttime pain relief

Tylenol PM is a meaningful substitute for consumers who avoid NSAIDs. Aleve PM is better positioned when consumers associate pain with inflammation, including back pain, joint pain, or muscle pain.

Aleve PM versus private-label products

Private-label products can replicate the active ingredients and dosage strengths at lower prices if they meet FDA requirements. Store brands typically compete through price, retailer promotion, and placement rather than through national advertising.

Private label creates the greatest pressure on Aleve PM during periods of consumer trade-down, inflation, or reduced promotional spending. Bayer can defend share through coupons, multipacks, retailer programs, and brand advertising, but these measures can reduce net realized pricing.

What is the financial trajectory of Aleve PM?

Aleve PM’s financial trajectory is likely mature to low-growth in volume, with revenue performance driven by price, mix, distribution, and promotional intensity rather than major market expansion.

Revenue drivers

The principal revenue drivers are:

Retail price increases.
Larger pack sizes.
Seasonal demand for pain and sleep products.
Continued Aleve brand distribution.
E-commerce availability.
Consumer preference for one-product nighttime treatment.
Retailer placement in analgesic and sleep-aid aisles.

Revenue constraints

The main constraints are:

Private-label substitution.
Competition from Advil PM and Tylenol PM.
Generic naproxen and diphenhydramine products.
Consumer migration to single-ingredient products.
Greater scrutiny of diphenhydramine use for sleep.
NSAID safety concerns.
Limited chronic-use potential.
Promotional discounting.

Bayer does not generally disclose Aleve PM revenue as a separate reporting line. Public Bayer reporting groups products within broader consumer-health categories, so investors cannot directly calculate Aleve PM sales, gross margin, or unit growth from company filings alone. [3]

Likely financial profile

Metric	Assessment
Product life-cycle stage	Mature
Unit growth	Flat to low growth
Revenue growth	Primarily price and mix driven
Margin profile	Likely attractive relative to prescription launches, but pressured by retail promotions
R&D requirement	Low
Regulatory expense	Low relative to prescription products
Manufacturing complexity	Moderate, based on combination-tablet production and quality controls
Patent-driven pricing power	Low
Brand-driven pricing power	Moderate
Generic substitution risk	High

What manufacturing and intellectual-property barriers affect Aleve PM?

Manufacturing barriers are operational rather than scientifically exclusive. A producer must reliably manufacture a combination product with:

Uniform naproxen sodium and diphenhydramine content.
Appropriate dissolution and stability.
Controlled sedating-antihistamine dose.
Consistent tablet hardness and coating.
Packaging that complies with child-resistant and OTC labeling requirements.
Supply-chain controls for active pharmaceutical ingredients.

These requirements do not create a substantial barrier for large OTC manufacturers. Contract manufacturers and private-label suppliers already possess the necessary capabilities for common analgesic and antihistamine products.

The most defensible commercial assets are the Aleve name, trade dress, retail relationships, and consumer advertising. Bayer can enforce trademark and unfair-competition rights against confusingly similar branding, but it cannot use those rights to block generic use of the active ingredients.

What litigation and settlement agreements affect Aleve PM?

No major public patent litigation or Paragraph IV settlement is associated with the standard Aleve PM product. That is consistent with its OTC status, mature active ingredients, and lack of a prescription-style exclusivity structure.

The more relevant legal exposures are:

Product-liability claims involving NSAID gastrointestinal or cardiovascular risks.
Claims involving excessive sedation or accidental ingestion.
Labeling and advertising disputes.
Consumer class actions involving marketing statements.
Trademark and trade-dress enforcement.
Manufacturing and quality-control matters.

These risks are portfolio-level exposures for Bayer Consumer Health and are not equivalent to patent litigation that would delay generic entry.

Which companies challenge Aleve PM commercially?

The competitive set includes branded manufacturers, private-label suppliers, and retailers.

Competitor	Product or category	Competitive basis
Haleon	Advil PM	Branded ibuprofen plus diphenhydramine
Kenvue	Tylenol PM	Branded acetaminophen plus diphenhydramine
Perrigo	Private-label OTC combinations	Retailer supply and low cost
CVS, Walgreens, Walmart, Target	Store brands	Price and shelf placement
Amazon and online OTC sellers	Generic and branded products	Search visibility and convenience
Other OTC manufacturers	Naproxen, ibuprofen, acetaminophen, sleep aids	Substitution across ingredients and indications

The market is fragmented at the manufacturer level but concentrated in national-brand recognition. Aleve PM’s commercial defense depends on maintaining a distinct nighttime proposition without eroding the broader Aleve brand’s association with daytime pain relief.

What generic launch scenarios exist for Aleve PM?

Because the product has no meaningful patent or regulatory exclusivity barrier, generic entry is not a future event. It is an ongoing commercial condition.

Scenario 1: Private-label price substitution

Retailers expand their own naproxen-diphenhydramine offerings and place them beside Aleve PM. This is the most direct threat to volume and price.

Scenario 2: Brand retention with premium pricing

Aleve PM retains consumers who prefer the Aleve brand, established packaging, and perceived reliability. Bayer preserves revenue through premium pricing and promotional support.

Scenario 3: Ingredient-level substitution

Consumers purchase separate naproxen and diphenhydramine products, or use a different nighttime analgesic. This reduces the value of the combination format.

Scenario 4: Safety-driven demand migration

Consumers or healthcare professionals shift away from diphenhydramine-containing sleep products or NSAID combinations because of sedation, anticholinergic, gastrointestinal, cardiovascular, or renal concerns.

Scenario 5: Retailer delisting or reduced shelf allocation

Retailers prioritize private-label products or higher-velocity brands, weakening Aleve PM’s physical distribution even if online availability remains stable.

How strong is the Aleve PM patent estate?

The patent estate is weak as a barrier to market entry and moderate as a supporting asset only where formulation, packaging, or brand-specific rights may exist.

Patent-estate dimension	Strength
Active-ingredient patents	None of practical commercial significance
Combination exclusivity	Low
Formulation protection	Limited or not material to entry
Manufacturing patents	Low barrier for established OTC manufacturers
Orange Book leverage	Limited
Trademark protection	Stronger than patent protection
Trade dress	Potentially relevant
Regulatory exclusivity	None comparable to prescription products
Litigation leverage	Primarily non-patent claims

Aleve PM is therefore a brand-management asset rather than an exclusivity asset.

What geographic markets does Aleve PM cover?

The principal commercial market is the United States. Product names, active-ingredient combinations, labeling, and regulatory status vary by country. Bayer’s Aleve brand has international presence, but that does not mean the Aleve PM formulation is marketed under the same name or with the same composition in every jurisdiction.

Geographic expansion is constrained by:

Country-specific OTC monographs.
Local rules for naproxen and diphenhydramine.
Different restrictions on sedating antihistamines.
Country-specific trademarks.
National labeling and pharmacovigilance requirements.
Retailer and pharmacy-channel differences.

The strongest near-term commercial opportunity remains U.S. brand optimization rather than patent-led geographic expansion.

What is the investment and licensing outlook for Aleve PM?

Aleve PM is unlikely to attract licensing interest based on molecule ownership, because both active ingredients are generic and widely available. A transaction would more likely involve:

A brand acquisition.
A regional commercialization agreement.
Contract manufacturing.
Retailer private-label supply.
Portfolio-level consumer-health assets.
Reformulation or line-extension rights.

The product can generate stable cash flow if distribution remains strong, but its low entry barriers reduce strategic scarcity. Licensing value depends on brand reach, retail contracts, manufacturing economics, and portfolio fit rather than on patent life.

Key Takeaways

Aleve PM combines 220 mg naproxen sodium with 25 mg diphenhydramine hydrochloride.
Its core market is U.S. OTC nighttime pain relief.
Product-specific revenue is not publicly disclosed by Bayer.
The product has no meaningful prescription-style exclusivity or Paragraph IV barrier.
Patent protection is weak; trademark, packaging, distribution, and brand equity are more important.
Advil PM and Tylenol PM are the principal branded substitutes.
Private-label products create persistent price and share pressure.
Revenue is likely mature, with performance driven by price, mix, distribution, and promotions.
Regulatory risk centers on NSAID and diphenhydramine safety labeling, not on approval failure.
Manufacturing barriers are manageable for established OTC producers.
The most credible commercial risks are trade-down, ingredient substitution, reduced shelf space, and safety-driven consumer migration.

FAQs

Is Aleve PM stronger than regular Aleve?

Aleve PM contains the same 220 mg naproxen sodium strength commonly used in regular Aleve caplets, but it adds 25 mg diphenhydramine hydrochloride. Its nighttime effect comes from the added antihistamine, not from a higher naproxen dose.

Can a generic company launch Aleve PM without an FDA patent challenge?

A company can generally market a compliant OTC equivalent without a conventional Paragraph IV challenge to Aleve PM, provided it follows the applicable FDA regulatory pathway and does not infringe Bayer trademarks or other enforceable rights.

Does Aleve PM have biosimilar competition?

No. Aleve PM is a small-molecule OTC combination product, not a biologic. Biosimilar competition is not relevant.

Is Aleve PM more exposed to private-label competition than prescription drugs?

Yes. OTC consumers can switch products easily, and retailers can source equivalent active ingredients from established manufacturers. Aleve PM therefore faces more immediate private-label pressure than a patented prescription medicine.

Could Bayer extend Aleve PM’s life cycle through a new formulation?

Yes. Potential extensions could include new dosage forms, pack sizes, modified dosing formats, or adjacent nighttime products. Such extensions would require regulatory and commercial support, but they would not automatically create durable exclusivity over the underlying naproxen-diphenhydramine combination.

References

U.S. National Library of Medicine. (n.d.). DailyMed: Aleve PM drug label. National Institutes of Health. https://dailymed.nlm.nih.gov/
U.S. Food and Drug Administration. (2020). Over-the-counter monograph drug products: Final administrative order and regulatory framework under the CARES Act. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs
Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/annual-reports
U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (2024). OTC monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. https://www.accessdata.fda.gov/-drugsatfda/otcmonographs.cfm

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4
What excipients (inactive ingredients) are in ALEVE PM?	ALEVE PM excipients list
DailyMed Link:	ALEVE PM at DailyMed

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

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