SUDAFED 12 HOUR Drug Patent Profile

When do Sudafed 12 Hour patents expire, and what generic alternatives are available?

Sudafed 12 Hour is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs.

The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sudafed 12 Hour

A generic version of SUDAFED 12 HOUR was approved as pseudoephedrine hydrochloride by L PERRIGO CO on February 26^th, 1999.

Summary for SUDAFED 12 HOUR

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	11
Patent Applications:	1,703
DailyMed Link:	SUDAFED 12 HOUR at DailyMed

Recent Clinical Trials for SUDAFED 12 HOUR

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

Sponsor	Phase
John Muir Health	N/A
Vanderbilt University	Early Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1

See all SUDAFED 12 HOUR clinical trials

US Patents and Regulatory Information for SUDAFED 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	SUDAFED 12 HOUR	pseudoephedrine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	017941-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mcneil Cons	SUDAFED 12 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	073585-001	Oct 31, 1991		DISCN	No	No

SUDAFED 12 HOUR Market Dynamics, Patent Status, and Financial Trajectory

Last updated: August 17, 2026

SUDAFED 12 HOUR is an extended-release pseudoephedrine hydrochloride product sold in the U.S. consumer-health market. Its commercial position is driven by brand recognition, seasonal respiratory demand, pharmacy-counter access, and distribution rather than patent exclusivity. The product is not protected by a meaningful active-ingredient patent estate, and Kenvue does not publicly report SUDAFED 12 HOUR revenue separately. Financial performance therefore must be assessed through the broader SUDAFED franchise, Kenvue's Self Care segment, retail scanner data, and category trends.

What is SUDAFED 12 HOUR and who markets it?

SUDAFED 12 HOUR contains 120 mg of pseudoephedrine hydrochloride in an extended-release tablet. The labeled adult and pediatric dosage for patients 12 years and older is generally one tablet every 12 hours, with no more than two tablets in 24 hours. The product is used for temporary relief of nasal and sinus congestion.

Product characteristic	SUDAFED 12 HOUR
Active ingredient	Pseudoephedrine hydrochloride
Strength	120 mg extended release
Dosage form	Extended-release oral tablet
U.S. regulatory pathway	OTC drug monograph and labeling framework
Current brand owner and marketer	Kenvue-branded consumer-health business
Primary channel	Pharmacies, mass retailers, grocery, club, and online channels
Prescription required	No, but pharmacy-counter controls apply
Biosimilar exposure	None
Primary competitors	Store-brand pseudoephedrine ER, Mucinex D, Advil Cold & Sinus, other combination products

The SUDAFED brand is part of Kenvue's consumer-health portfolio following the separation of Kenvue from Johnson & Johnson. Kenvue reports financial results by operating segment and major brand families, but does not disclose revenue or operating profit for SUDAFED 12 HOUR as an individual stock-keeping unit (Kenvue, 2024).

What is the difference between SUDAFED 12 HOUR and SUDAFED PE?

SUDAFED 12 HOUR and SUDAFED PE are not interchangeable products. SUDAFED 12 HOUR uses pseudoephedrine, while many SUDAFED PE products use phenylephrine.

Issue	SUDAFED 12 HOUR	SUDAFED PE
Active ingredient	Pseudoephedrine	Phenylephrine in applicable products
Decongestant status	Established oral decongestant active ingredient	FDA questioned oral effectiveness of phenylephrine
Retail access	Pharmacy-counter controls	Generally front-shelf OTC access, depending on product
Methamphetamine diversion controls	Applies	Does not apply in the same way
FDA 2023 review relevance	Not the subject of the proposed phenylephrine removal	Directly affected by FDA's proposed action

In 2023, FDA proposed removing oral phenylephrine from the OTC monograph after concluding that available data did not support its effectiveness at the marketed oral dose. That action concerned oral phenylephrine, not pseudoephedrine. It therefore does not directly remove the regulatory basis for SUDAFED 12 HOUR (FDA, 2023).

What patents protect SUDAFED 12 HOUR?

No commercially material, unexpired U.S. patent is generally associated with the basic pseudoephedrine hydrochloride extended-release product. Pseudoephedrine is an old active ingredient, and the core product concept has been available for decades.

The remaining protection profile is primarily regulatory and commercial:

Protection category	SUDAFED 12 HOUR status
Active-ingredient patent	Expired or not commercially relevant
Basic extended-release formulation patent	No known blocking patent of current commercial significance
Method-of-use patent	No material patent exclusivity identified for ordinary congestion relief
Orange Book-listed patent	No meaningful patent barrier expected for an OTC monograph product
FDA exclusivity	No meaningful modern exclusivity period
Brand trademark	Commercially important and likely the strongest formal IP asset
Trade dress and packaging	Potentially enforceable, but not a barrier to store-brand competition
Manufacturing know-how	Potential process and supplier advantages, but no demonstrated market blockade

OTC monograph products do not generally use the same Orange Book patent-certification structure as prescription drugs approved through a new drug application. A generic or private-label manufacturer can compete by complying with the applicable FDA OTC requirements, labeling rules, active-ingredient specifications, manufacturing controls, and applicable state and federal restrictions.

When did SUDAFED 12 HOUR lose exclusivity?

The product's practical exclusivity ended long before the current market period. Pseudoephedrine products have faced generic and store-brand competition for many years. The relevant commercial question is not patent expiry but whether the SUDAFED trademark can sustain a price premium over equivalent pseudoephedrine extended-release products.

SUDAFED's advantages include:

• High consumer awareness.
• Strong pharmacy recognition.
• Retailer distribution.
• Familiar dosing and packaging.
• Consumer preference for pseudoephedrine over phenylephrine in some congestion categories.

Its disadvantages include:

• Direct substitution by lower-priced store brands.
• Pharmacy-counter purchasing friction.
• Purchase limits.
• Seasonal demand volatility.
• Limited ability to raise prices without accelerating private-label switching.

How does pharmacy-counter regulation affect the market?

The Combat Methamphetamine Epidemic Act of 2005 placed pseudoephedrine products behind the pharmacy counter and imposed sales, identification, recordkeeping, and purchase-limit requirements. Federal daily and monthly limits apply, with state laws adding restrictions in some jurisdictions (U.S. Congress, 2005; DEA, n.d.).

These controls affect market dynamics in four ways.

First, they reduce impulse purchases. A consumer typically must request the product from a pharmacist or pharmacy counter employee.

Second, they increase retailer operating costs through inventory controls, compliance systems, employee procedures, and sales-record requirements.

Third, they limit online convenience. Retailers must use identity verification and other controls for lawful remote sales.

Fourth, they create a competitive distinction between pseudoephedrine and front-shelf phenylephrine products. The distinction can redirect some consumers toward products with easier access, even when pseudoephedrine is perceived as more effective.

What is the Orange Book status of SUDAFED 12 HOUR?

SUDAFED 12 HOUR is not best analyzed as a patent-protected prescription product with a conventional Orange Book market-exclusivity strategy. Its market access rests on OTC regulation, monograph compliance, manufacturing quality, and trademark rights.

A competitor seeking to sell a pseudoephedrine extended-release product would generally face:

1. FDA active-ingredient and dosage-form requirements.
2. Drug Facts labeling requirements.
3. Current good manufacturing practice obligations.
4. Pseudoephedrine sales controls.
5. Retailer and state-law compliance.
6. Trademark and packaging restrictions.

Those requirements create execution costs but do not create durable brand-level exclusivity.

Are there Paragraph IV challenges or generic litigation?

A conventional Paragraph IV challenge is not the principal risk to SUDAFED 12 HOUR because the product is an OTC monograph product rather than a standard prescription NDA product with a current Orange Book patent listing.

The competitive threat is ordinary generic and private-label entry. Store brands can sell comparable pseudoephedrine extended-release products at lower prices, subject to FDA and controlled-sales requirements. Competition may occur through:

• National pharmacy chains.
• Mass merchants.
• Grocery retailers.
• Club stores.
• Online pharmacies.
• Contract manufacturers supplying private-label products.

The likely legal disputes are trademark, trade dress, advertising, labeling, manufacturing quality, and distribution matters rather than patent litigation over the active ingredient.

What formulation patents protect extended-release pseudoephedrine?

Extended-release technology can be protected in principle by formulation and manufacturing patents. Possible claim areas include matrix systems, coating systems, release-control polymers, tablet structure, coating processes, and stability methods.

For SUDAFED 12 HOUR, however, the presence of historical formulation patents would not by itself establish current exclusivity. Relevant patents would need to be:

• U.S.-issued.
• Unexpired.
• Assigned or licensed to the relevant brand owner.
• Directed to the marketed product.
• Enforceable against a competing product.
• Material to the product's commercial manufacture.

The current business risk is therefore more likely to involve supply-chain qualification, quality systems, and brand economics than a live formulation patent blocking generic entry.

How strong is the SUDAFED 12 HOUR patent estate?

The patent estate is weak as a source of current exclusion but the brand estate is commercially stronger.

Asset	Relative strength	Commercial effect
Pseudoephedrine active ingredient	Low	Commodity-like competition
Extended-release formulation	Low to moderate historically; low current blocking value	May support manufacturing know-how
SUDAFED trademark	High consumer value	Supports recognition and shelf conversion
Packaging and trade dress	Moderate	Can deter confusing imitation
Retail distribution	Moderate	Supports availability and seasonal execution
OTC regulatory compliance	Moderate operational barrier	Raises entry cost but does not prevent entry
Pharmacy-counter infrastructure	Moderate	Favors experienced suppliers and retailers

The key strategic asset is the SUDAFED name, not patent exclusivity. The brand can preserve a premium if consumers believe it offers more reliable congestion relief, better availability, or lower purchasing risk. Private-label products constrain that premium.

What is the financial trajectory for SUDAFED 12 HOUR?

Kenvue does not disclose SUDAFED 12 HOUR revenue separately. Public company filings therefore cannot establish product-level sales, gross margin, market share, or cash flow.

Kenvue reports a broader Self Care portfolio that includes brands such as TYLENOL, MOTRIN, Zyrtec, BENADRYL, Nicorette, and SUDAFED. Product-level results are affected by seasonal respiratory demand, retailer inventory, pricing, promotional activity, raw-material costs, foreign-exchange effects, and consumer trade-down.

The likely financial trajectory has four characteristics:

Mature revenue base

SUDAFED 12 HOUR is a mature OTC product. Growth is more likely to come from pricing, distribution, pack-size optimization, merchandising, and category share than from new indications or patent-protected expansion.

Seasonal volatility

Demand normally increases during cold, influenza, allergy, and sinus-symptom periods. A mild respiratory season can reduce unit movement. Severe or prolonged seasonal illness can produce temporary demand spikes, followed by retailer destocking.

Margin pressure from private label

Pseudoephedrine is available in generic formats. Retailers can use their own brands to capture margin and offer lower prices. This places pressure on branded pricing and promotional returns.

Limited innovation upside

The 12-hour delivery format is already established. Incremental growth may come from packaging, combination products, e-commerce availability, or broader merchandising rather than a new technology platform.

Kenvue's financial reports should be used to monitor the relevant segment, but they cannot support a standalone SUDAFED 12 HOUR valuation without third-party retail data or management disclosure (Kenvue, 2024).

Which companies compete with SUDAFED 12 HOUR?

Competition is fragmented because the product competes against both equivalent pseudoephedrine products and alternative decongestants.

Direct pseudoephedrine competitors

• Walgreens, CVS, Walmart, Target, and supermarket private-label products.
• Mucinex D and related pseudoephedrine combination products.
• Advil Cold & Sinus and other ibuprofen-pseudoephedrine products.
• Generic pseudoephedrine hydrochloride extended-release tablets.

Indirect competitors

• Phenylephrine products.
• Oxymetazoline nasal sprays.
• Saline nasal products.
• Antihistamine and decongestant combinations.
• Non-drug congestion remedies.

The most economically relevant competitors are store brands and combination products. Store brands pressure price. Combination products expand the value proposition by pairing decongestion with pain, cough, or expectorant treatment.

What generic launch risks exist for SUDAFED 12 HOUR?

Generic entry is already established, so the risk is ongoing share erosion rather than a single future launch event.

The principal scenarios are:

Scenario	Likely effect
Stable respiratory demand	Brand maintains revenue through recognition and distribution
Increased retailer private-label promotion	Unit and price share shift away from SUDAFED
Supply disruption affecting generic competitors	Temporary branded volume benefit
Strong online pharmacy adoption	Improved access but greater price transparency
Tighter pseudoephedrine controls	Lower category convenience and possible volume pressure
Consumer shift to alternative decongestants	Reduced pseudoephedrine category demand
Higher manufacturing or compliance costs	Margin compression

The strongest near-term risk is retailer substitution, not patent invalidation. The brand can lose volume without any litigation if retailers allocate more shelf, promotional funding, and search visibility to private-label equivalents.

What licensing deals affect SUDAFED 12 HOUR?

No major current licensing transaction is publicly identified as the primary driver of SUDAFED 12 HOUR economics. The product is associated with Kenvue's branded consumer-health portfolio following the Johnson & Johnson consumer-health separation.

The relevant commercial rights are likely to include:

• Trademark ownership and licensing.
• Contract manufacturing arrangements.
• Wholesale and retail distribution agreements.
• Packaging and component supply contracts.
• Retailer-specific private-label relationships, where applicable.

These arrangements are not generally disclosed at the individual product level. No evidence indicates that a third-party license creates a current patent royalty burden that determines SUDAFED 12 HOUR profitability.

What is the geographic coverage of SUDAFED 12 HOUR?

The principal commercial analysis is U.S.-focused because pseudoephedrine controls, OTC classifications, pharmacy-counter rules, and product availability vary by jurisdiction.

Outside the United States, equivalent pseudoephedrine extended-release products may be sold under different brand names, dosage formats, or prescription classifications. The SUDAFED trademark has international relevance, but product composition and market access cannot be assumed to match the U.S. 12-hour formulation.

U.S. economics are shaped by federal purchase limits and state-level restrictions. International growth would depend on local regulatory classification, pharmacy rules, local brand ownership, and market-specific competition.

What manufacturing and intellectual-property barriers affect the product?

Manufacturing barriers are practical rather than patent-based. A supplier must qualify an extended-release tablet process, control dissolution performance, maintain content uniformity, manage stability, and comply with FDA current good manufacturing practices.

Pseudoephedrine sourcing also requires controlled inventory management and documented sales compliance. These requirements can favor established companies with qualified suppliers and retailer systems. They do not prevent a capable generic manufacturer from entering.

The most defensible IP assets are the SUDAFED trademark, brand recognition, packaging, retailer relationships, and accumulated consumer trust. Those assets support pricing and distribution but do not eliminate substitution.

What is the outlook for SUDAFED 12 HOUR?

SUDAFED 12 HOUR should be valued as a mature branded OTC product with recurring but seasonal demand. Its outlook depends on brand premium retention, retailer distribution, pharmacy-counter availability, private-label intensity, and broader respiratory-category demand.

The product has low patent risk for competitors and moderate commercial resilience. Revenue is likely to be stable to pressured over time unless Kenvue improves pricing, distribution, or portfolio positioning. The product's financial contribution is likely meaningful at the brand-family level but cannot be isolated from public filings.

Key Takeaways

• SUDAFED 12 HOUR is a 120 mg pseudoephedrine hydrochloride extended-release tablet.
• Kenvue is the relevant U.S. consumer-health brand owner and marketer.
• The product has no apparent current patent barrier comparable to a prescription drug exclusivity estate.
• OTC monograph compliance, pharmacy-counter controls, and manufacturing quality are the main entry requirements.
• Paragraph IV litigation is not the central competitive issue.
• Store brands and combination cold medicines are the primary commercial threats.
• Kenvue does not disclose SUDAFED 12 HOUR revenue separately.
• Financial performance is seasonal and exposed to private-label price competition.
• The SUDAFED trademark and distribution network are more valuable than patent exclusivity.
• Biosimilar risk is irrelevant because SUDAFED 12 HOUR is a small-molecule OTC drug, not a biologic.

FAQs

Is SUDAFED 12 HOUR still patent protected?

No material current patent exclusivity is generally associated with the basic product. Its competitive protection comes mainly from the SUDAFED trademark, distribution, and consumer recognition.

Can a generic manufacturer sell a 12-hour pseudoephedrine product?

Yes. Generic manufacturers can compete if they satisfy FDA OTC requirements, extended-release product standards, manufacturing rules, labeling obligations, and pseudoephedrine purchase controls.

Does FDA's phenylephrine action affect SUDAFED 12 HOUR?

No. FDA's 2023 proposed action addressed oral phenylephrine. SUDAFED 12 HOUR uses pseudoephedrine hydrochloride.

Why is pseudoephedrine sold behind the pharmacy counter?

Federal law imposes controls because pseudoephedrine can be diverted for illicit methamphetamine production. Retailers must follow identification, recordkeeping, purchase-limit, and inventory requirements.

Is SUDAFED 12 HOUR revenue disclosed by Kenvue?

No. Kenvue reports broader segment and brand-family results rather than standalone revenue for the individual SUDAFED 12 HOUR product.

References

1. Drug Enforcement Administration. (n.d.). Pseudoephedrine: Federal and state regulations. U.S. Department of Justice. https://www.dea.gov
2. Food and Drug Administration. (2023). FDA proposes ending use of oral phenylephrine as OTC monograph nasal decongestant. U.S. Department of Health and Human Services. https://www.fda.gov
3. Kenvue Inc. (2024). Annual report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission. https://www.sec.gov
4. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Pub. L. No. 109-177. https://www.congress.gov