NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile

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Which patents cover Naproxen Sodium And Pseudoephedrine Hydrochloride, and what generic alternatives are available?

Naproxen Sodium And Pseudoephedrine Hydrochloride is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo. and is included in three NDAs.

The generic ingredient in NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE is naproxen sodium; pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naproxen Sodium And Pseudoephedrine Hydrochloride

A generic version of NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17^th, 2004.

Summary for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	10
Clinical Trials:	2
DailyMed Link:	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1

See all NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors

US Patents and Regulatory Information for NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	211360-001	Jun 1, 2022		OTC	No	No
Dr Reddys Labs Inc	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077381-001	Sep 27, 2006		OTC	No	No
Perrigo	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	naproxen sodium; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076518-001	Mar 17, 2004		OTC	No	Yes

Naproxen Sodium and Pseudoephedrine Hydrochloride Market Dynamics and Financial Trajectory

Last updated: November 1, 2026

Naproxen sodium 220 mg plus pseudoephedrine hydrochloride 120 mg is a mature U.S. over-the-counter combination used for sinus congestion, headache, fever, and minor aches. The best-known branded product is Bayer’s Aleve-D Sinus & Cold. Its commercial outlook depends on brand recognition, retailer distribution, pseudoephedrine purchasing restrictions, and consumer migration away from oral phenylephrine. Patent exclusivity is not the principal market barrier. The product competes in a largely commoditized OTC category with limited public revenue disclosure.

What is naproxen sodium and pseudoephedrine hydrochloride?

The combination pairs an analgesic and anti-inflammatory drug with an oral nasal decongestant.

Component	Function	Typical product strength
Naproxen sodium	NSAID analgesic and antipyretic	220 mg
Pseudoephedrine hydrochloride	Systemic nasal decongestant	120 mg extended release
Dosage form	Extended-release caplet	One caplet every 12 hours
Maximum labeled use	Short-term OTC treatment	Two caplets per 24 hours

Naproxen sodium is the sodium salt of naproxen and provides analgesic, antipyretic, and anti-inflammatory activity. Pseudoephedrine constricts nasal blood vessels and reduces congestion. The combination targets consumers who want relief from both sinus congestion and pain without taking separate products.

The principal branded U.S. product is Aleve-D Sinus & Cold, marketed by Bayer Consumer Health. The product is sold through pharmacies and retailers, but pseudoephedrine products are generally placed behind the pharmacy counter because of federal sales controls.

How large is the naproxen-pseudoephedrine market?

The exact market size is not publicly disclosed for the active-ingredient combination. Retail audit companies and manufacturers generally report broader categories such as internal analgesics, cold remedies, or decongestants rather than sales for a particular two-ingredient formulation.

The market has four economically relevant segments:

1. Branded combination products such as Aleve-D Sinus & Cold.
2. Store-brand or private-label equivalents.
3. Competing ibuprofen-pseudoephedrine products, including Advil Cold & Sinus and equivalents.
4. Separate analgesic and decongestant products purchased together.

The combination is a niche within the larger U.S. OTC pain-relief and cough, cold, and allergy markets. It is unlikely to have the scale of standalone naproxen, ibuprofen, acetaminophen, or leading multi-symptom cold brands.

What drives demand?

Demand is seasonal and illness-driven. Sales normally increase during winter respiratory-virus periods, allergy seasons, and episodes of sinus congestion. The product also benefits from consumers seeking a single caplet for pain and congestion.

Key demand drivers include:

• Brand familiarity with Aleve.
• Preference for naproxen’s longer dosing interval compared with some short-acting analgesics.
• Continued consumer use of pseudoephedrine after FDA action against oral phenylephrine.
• Retailer placement and pharmacist availability.
• Household demand for nonprescription congestion relief.
• Seasonal influenza, common-cold, and allergy activity.

Demand is constrained by NSAID safety concerns, pseudoephedrine purchase friction, package-size restrictions, and competition from standalone products.

What is the financial trajectory for Aleve-D and comparable products?

Bayer does not publicly report revenue for Aleve-D as a standalone product. Its sales are included within the broader Consumer Health segment and brand portfolio. Public filings therefore support analysis of portfolio exposure, but not a verified product-level revenue series. [1]

The financial trajectory is best characterized as mature, stable-to-declining in volume, with periodic seasonal increases and potential price support.

Financial factor	Expected effect
Mature OTC status	Limits high growth
Brand pricing	Supports revenue relative to private label
Private-label competition	Pressures unit share and margins
Pseudoephedrine demand	Supports differentiation from phenylephrine products
Pharmacy-counter restrictions	Reduces convenience and impulse purchases
Inflation and retailer pricing	Can raise nominal revenue while reducing volume
Seasonal illness	Creates quarterly volatility
No meaningful patent exclusivity	Limits premium protection over equivalents

Bayer can preserve revenue through brand equity, shelf presence, package architecture, and retailer relationships. It cannot rely on patent-based pricing power. Private-label products can compete on price because the active ingredients are established OTC drugs and the formulation is technically straightforward.

The product’s financial profile is therefore a cash-generative mature-brand model rather than a growth pharmaceutical model. Revenue is likely to be driven more by distribution, consumer promotion, and pricing than by clinical differentiation.

When does naproxen-pseudoephedrine lose exclusivity?

The combination does not have a conventional prescription-drug exclusivity timeline. It is marketed under the FDA’s OTC framework, and the relevant commercial protection comes from trademarks, brand recognition, manufacturing scale, retailer access, and regulatory compliance.

Naproxen sodium and pseudoephedrine hydrochloride are long-established active ingredients. Their basic pharmacological and chemical protections have expired. Any historical formulation or process patents that may have covered particular products do not create a current broad exclusivity position for the combination.

The practical conclusion is:

• There is no meaningful current patent cliff comparable to a branded prescription drug.
• Generic and private-label competition can enter without waiting for a new-molecular-entity exclusivity period.
• The main commercial asset is the Aleve trademark and associated consumer trust.
• Product-level sales depend on OTC distribution rather than Hatch-Waxman exclusivity.

What is the Orange Book status of naproxen sodium and pseudoephedrine?

Naproxen sodium and pseudoephedrine combination products are generally not Orange Book products in the same way as prescription drugs approved through a New Drug Application.

The FDA Orange Book primarily identifies approved drug products and patent or exclusivity information relevant to generic prescription-drug approval. A conventional OTC monograph product does not normally have an Orange Book patent listing that blocks an abbreviated new drug application.

The applicable regulatory framework is based on OTC monograph requirements, labeling, active-ingredient conditions, and current good manufacturing practices. FDA regulations governing internal analgesic products and oral nasal decongestants provide the relevant regulatory foundation. [2, 3]

What FDA regulatory status applies to the product?

The combination is regulated as an OTC drug. Naproxen sodium is governed by the FDA’s OTC internal analgesic framework, while pseudoephedrine is governed by the OTC nasal-decongestant framework. Product labeling must comply with permitted active ingredients, doses, indications, warnings, directions, and packaging requirements. [2, 3]

The product is subject to the following regulatory constraints:

• NSAID warnings relating to stomach bleeding, ulceration, cardiovascular risk, and allergic reactions.
• Decongestant warnings relating to hypertension, heart disease, thyroid disease, diabetes, and certain drug interactions.
• Age and dosing restrictions.
• Tamper-resistant and child-resistant packaging requirements where applicable.
• Pseudoephedrine sales-record and quantity restrictions.
• Manufacturing and quality requirements under FDA regulations.

The FDA has separately proposed removing oral phenylephrine from the OTC monograph after concluding that oral phenylephrine is not effective as a nasal decongestant at the currently marketed dose. That regulatory development may improve the relative position of pseudoephedrine-containing products, although it does not eliminate pseudoephedrine’s purchasing restrictions. [4]

What patents protect naproxen sodium and pseudoephedrine hydrochloride products?

No current broad patent estate is the central commercial barrier for the standard 220 mg naproxen sodium and 120 mg pseudoephedrine hydrochloride combination.

Potential historical protection areas include:

Protection area	Current commercial relevance
Naproxen compound patents	Expired
Pseudoephedrine compound patents	Expired
Basic combination claims	Generally expired or unavailable as a broad barrier
Extended-release formulation	May have been covered historically, but does not create broad current exclusivity without an active, enforceable claim
Packaging and labeling	Limited protection; generally not a barrier to equivalent products
Manufacturing process	May create confidential know-how, but standard ingredients are widely available
Trademark	Most important continuing brand protection

An effective patent-strength assessment requires a product-specific search of issued claims, expiration dates, terminal disclaimers, and post-grant status. For commercial planning, the key point is that the formulation is not protected like a recently approved prescription combination.

Are there Paragraph IV challenges for naproxen-pseudoephedrine?

Paragraph IV litigation is not the normal competitive pathway for a conventional OTC monograph combination. Paragraph IV certifications apply to abbreviated new drug applications that challenge listed patents in the Orange Book. Because the product is generally regulated through the OTC monograph pathway rather than an Orange Book-listed NDA, a standard Paragraph IV launch dispute is unlikely.

Competitive entry is more likely to occur through:

• OTC monograph compliance.
• Private-label manufacturing arrangements.
• Retailer-branded products.
• Separate-component substitution.
• State and federal pseudoephedrine compliance.
• Trademark and trade-dress disputes.

This reduces litigation risk relative to patented prescription drugs. It also reduces the ability of the branded manufacturer to delay competitors through patent settlements.

What formulation patents protect the extended-release product?

The extended-release design is commercially useful because it allows twice-daily dosing. It is not, by itself, evidence of current patent exclusivity.

A competitor can pursue an equivalent product by using a compliant extended-release formulation or by selling separate immediate-release and extended-release products that satisfy OTC requirements. The technical barriers are modest compared with complex modified-release prescription drugs, biologics, inhalation products, or sterile injectables.

Potential formulation risks include:

• Failure to match pseudoephedrine release characteristics.
• Dose-dumping or stability problems.
• Inconsistent dissolution performance.
• Labeling differences affecting dosing instructions.
• Manufacturing controls for dual-active-ingredient caplets.
• Bioequivalence or quality expectations imposed by the applicable regulatory route.

These issues can delay a launch, but they are manufacturing and regulatory execution risks rather than durable patent barriers.

Which companies compete with Aleve-D?

The competitive landscape includes branded manufacturers, generic OTC suppliers, retailers, and manufacturers selling separate products.

Competitor type	Representative products or strategy
Branded NSAID-decongestant	Advil Cold & Sinus, containing ibuprofen and pseudoephedrine
Store brands	Retailer-labeled naproxen-pseudoephedrine or ibuprofen-pseudoephedrine products
Standalone analgesics	Aleve, Advil, Motrin, acetaminophen products
Standalone decongestants	Behind-the-counter pseudoephedrine products
Multi-symptom cold products	Combination products using acetaminophen, dextromethorphan, antihistamines, and decongestants
Non-drug alternatives	Saline sprays, nasal irrigation, humidification, and topical products

The most direct branded comparison is Aleve-D versus ibuprofen-pseudoephedrine products. Naproxen has a longer nominal dosing interval, while ibuprofen has broader consumer familiarity in the cold-and-sinus category. Product choice often depends on price, prior experience, contraindications, and retailer availability.

How does Aleve-D compare with ibuprofen-pseudoephedrine products?

Attribute	Naproxen sodium-pseudoephedrine	Ibuprofen-pseudoephedrine
Analgesic class	Naproxen NSAID	Ibuprofen NSAID
Typical analgesic dose	220 mg naproxen sodium	200 mg ibuprofen
Decongestant	Pseudoephedrine	Pseudoephedrine
Dosing perception	Longer interval associated with naproxen	Familiar short-acting NSAID positioning
Key safety concerns	GI bleeding, cardiovascular risk, renal effects	GI bleeding, cardiovascular risk, renal effects
Brand position	Aleve brand equity	Advil and other ibuprofen brand equity
Direct substitution	High	High
Patent protection	Minimal current protection	Minimal current protection

Neither product has a major regulatory exclusivity advantage. Commercial performance is more likely to reflect brand marketing, retailer placement, price, and consumer preference than meaningful clinical differentiation.

What generic entry risks exist?

Generic and private-label entry risk is high in economic terms because the active ingredients are mature and the product is sold in a competitive OTC market.

The main risks to the branded product are:

1. Retailer substitution into private-label products.
2. Lower-priced pseudoephedrine combinations from generic manufacturers.
3. Consumer use of separate naproxen and pseudoephedrine products.
4. Retailer delisting or reduced shelf visibility.
5. Promotional price compression.
6. Expansion of competing ibuprofen-pseudoephedrine products.
7. Consumer movement toward topical or non-oral decongestants.

The risk is gradual share erosion rather than a single post-patent launch event. A strong brand can maintain a price premium, but the premium is vulnerable where retailers control the customer relationship.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are moderate but not high. The product requires reliable sourcing of two established active ingredients and a controlled extended-release dosage form. Pseudoephedrine compliance adds supply-chain and sales-record obligations.

Key operational barriers include:

• Controlled distribution and inventory tracking for pseudoephedrine.
• State-level purchasing rules.
• Batch-to-batch release testing.
• Extended-release dissolution control.
• Stability and packaging performance.
• Dual-active-ingredient labeling.
• Retailer and pharmacy-counter distribution agreements.
• Compliance with OTC monograph conditions.

The supply chain is more regulated than a standard analgesic because pseudoephedrine is a precursor subject to federal quantity limits and recordkeeping. The Combat Methamphetamine Epidemic Act limits retail pseudoephedrine sales and imposes purchaser-identification and storage requirements. [5]

What licensing deals affect naproxen-pseudoephedrine?

No major recent licensing transaction is publicly associated with the core naproxen sodium-pseudoephedrine combination. Commercial arrangements are more likely to involve:

• Contract manufacturing.
• Retailer private-label supply.
• Distribution agreements.
• Brand licensing.
• Portfolio acquisitions involving OTC products.

Bayer’s principal asset is the Aleve brand and its consumer-health distribution infrastructure. The combination itself is not a differentiated platform technology that would normally generate substantial royalty-bearing licensing activity.

What litigation and settlement agreements affect the product?

There is no widely reported current Hatch-Waxman litigation or patent-settlement structure controlling entry for the standard OTC combination. Litigation exposure is more likely to involve:

• Product-liability claims concerning NSAID gastrointestinal or cardiovascular risks.
• False-advertising or comparative-marketing claims.
• Trademark and trade-dress disputes.
• Manufacturing-quality matters.
• Retailer or distributor contract disputes.
• Regulatory enforcement involving pseudoephedrine controls.

This litigation profile is materially different from prescription products with active formulation patents and a large Paragraph IV challenger pipeline.

What is the generic launch scenario?

The most likely launch scenario is incremental private-label expansion rather than a concentrated wave of ANDA launches.

Base case

Aleve-D retains a premium position, but private-label products gain share through pharmacy and mass-retail channels. Nominal revenue remains supported by price increases and seasonal demand, while unit volume gradually declines.

Upside case

FDA action against oral phenylephrine increases consumer and retailer attention toward pseudoephedrine products. Aleve-D benefits from its established brand, naproxen positioning, and nationwide availability.

Downside case

Pseudoephedrine restrictions, retailer substitution, adverse publicity about NSAID risks, and aggressive store-brand pricing reduce branded volume. Consumers shift to separate products or competing ibuprofen combinations.

What geographic markets matter?

The United States is the most commercially relevant market because pseudoephedrine regulation, OTC monograph treatment, and the Aleve brand are particularly important there.

Geographic considerations include:

• U.S. federal pseudoephedrine restrictions.
• State-level sales and identification requirements.
• Different OTC classification rules outside the United States.
• Local availability of naproxen and pseudoephedrine combinations.
• Country-specific restrictions on pseudoephedrine because of diversion concerns.
• Different brand ownership and licensing arrangements in foreign markets.

A U.S. market assessment should not be extrapolated directly to Europe or Asia-Pacific. Pseudoephedrine availability and pharmacy controls vary significantly by country.

How strong is the patent estate?

The patent estate is weak as a current source of exclusivity but adequate as part of a broader brand and supply-chain strategy.

Factor	Assessment
Active-ingredient patent strength	Very low
Combination patent strength	Low
Formulation patent strength	Potentially relevant only if an unexpired claim applies
Orange Book leverage	Limited or absent for OTC monograph products
Trademark strength	High for the Aleve brand
Manufacturing know-how	Moderate
Regulatory compliance barrier	Moderate
Retail distribution advantage	Potentially strong
Generic substitution risk	High

The product’s defensibility is commercial, not primarily patent-based.

Key Takeaways

• Naproxen sodium and pseudoephedrine hydrochloride is a mature OTC combination, best known through Aleve-D Sinus & Cold.
• Bayer does not publicly disclose standalone Aleve-D revenue.
• The product has no meaningful current small-molecule exclusivity advantage.
• Orange Book and Paragraph IV mechanisms are generally not central to this OTC monograph product.
• Private-label substitution is the principal competitive risk.
• Pseudoephedrine purchasing restrictions increase operating complexity but may support demand relative to oral phenylephrine.
• FDA’s proposed action against oral phenylephrine could improve the relative position of pseudoephedrine products.
• Revenue is likely to remain seasonal and mature, with price support offsetting gradual unit pressure.
• The strongest assets are the Aleve trademark, retailer distribution, pharmacist access, and consumer familiarity.
• Generic entry is likely to be gradual and channel-driven rather than triggered by a single patent expiration date.

Frequently Asked Questions

Is Aleve-D a prescription drug?

No. Aleve-D is an OTC product. Pseudoephedrine is generally sold behind the pharmacy counter because of federal purchasing controls.

Does naproxen sodium-pseudoephedrine have a patent expiration date?

There is no single commercially decisive patent expiration date comparable to a patented prescription drug. The active ingredients are longstanding, and the product competes primarily through brand and distribution.

Can a generic manufacturer sell naproxen-pseudoephedrine without a Paragraph IV challenge?

Potentially yes, if the product follows the applicable OTC regulatory pathway and complies with FDA labeling, manufacturing, and pseudoephedrine-control requirements. A conventional Orange Book Paragraph IV challenge is not the normal route.

Is pseudoephedrine more commercially attractive after the FDA’s phenylephrine action?

Potentially. FDA’s proposed determination that oral phenylephrine is ineffective at the current OTC dose may shift consumer and retailer attention toward pseudoephedrine, although purchasing restrictions remain a constraint. [4]

What is the principal investment risk for Aleve-D?

The principal risk is gradual branded-share erosion from private-label products, competing ibuprofen-pseudoephedrine products, and separate-component purchases. Patent litigation is not the main risk.

References

1. Bayer AG. (2024). Annual report 2023. Bayer AG.

2. U.S. Food and Drug Administration. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (2024). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024). Proposed order: Oral phenylephrine is not generally recognized as safe and effective for use as a nasal decongestant. U.S. Department of Health and Human Services.

5. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005.