Generic PSEUDOEPHEDRINE SULFATE INN entry, drug patent expiration information and freedom to operate

Sponsor	Phase
Bayer	Phase 1
Bayer	Phase 4
Magna Pharmaceuticals, Inc.	Phase 3

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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
Schering Plough	AFRINOL	pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018191-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ 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 27, 2026

Pseudoephedrine sulfate is a mature, generic oral nasal decongestant with limited patent value and stable underlying medical demand. Its commercial trajectory is determined less by innovation than by federal purchase limits, state restrictions, methamphetamine-prevention controls, seasonal respiratory illness, retailer policies, and competition from pseudoephedrine hydrochloride and alternative decongestants. The product remains FDA-recognized for OTC use, but sales are restricted to behind-the-counter channels in the United States. No major branded exclusivity period or Orange Book patent estate currently drives the U.S. market.

What is the current market position of pseudoephedrine sulfate?

Pseudoephedrine sulfate is the sulfate salt of pseudoephedrine, a sympathomimetic nasal decongestant. It reduces nasal congestion through vasoconstriction of swollen nasal mucosa. The active ingredient is sold primarily in immediate-release and extended-release oral tablets, capsules, and combination cold products.

The U.S. market is highly genericized. Brand and store-brand products compete on availability, dosage form, price, retailer distribution, and combination ingredients rather than on clinically differentiated technology.

Market factor	Current impact
Product maturity	Generic, low-differentiation market
Primary demand	Seasonal cold, influenza, and allergy symptoms
U.S. sales channel	Behind the pharmacy counter
Prescription requirement	Generally not required federally, but purchaser identification and transaction logging apply
Key competitors	Pseudoephedrine hydrochloride, phenylephrine products, topical decongestants, antihistamine combinations
Patent barrier	No material composition-of-matter barrier expected for the mature active ingredient
Regulatory constraint	Combat Methamphetamine Epidemic Act purchase limits and state-level restrictions
Commercial risk	Retail access, supply interruptions, regulatory controls, and seasonal volatility

Pseudoephedrine sulfate competes directly with pseudoephedrine hydrochloride. The sulfate and hydrochloride salts deliver the same active moiety, but their labeled milligram strengths are not directly interchangeable on a mass basis because the salt molecular weights differ. Manufacturers therefore compete mainly through formulation, pack size, retailer placement, and supply reliability.

How large is the pseudoephedrine sulfate market?

No authoritative public source reports a standalone global market value for pseudoephedrine sulfate. Public companies generally combine the product with broader consumer-health categories, oral decongestants, or over-the-counter respiratory products in financial reporting.

The market is best analyzed in layers:

Active pharmaceutical ingredient sales to finished-dose manufacturers.
Finished-dose generic tablets and capsules.
Combination cold and allergy products.
Retail pharmacy and mass-market sales.

Retail revenue is higher than manufacturer revenue because it includes wholesaler, retailer, and pharmacy margins. Published commercial-market estimates frequently combine pseudoephedrine hydrochloride, pseudoephedrine sulfate, combination products, and other decongestants. Those estimates should not be treated as audited revenue for pseudoephedrine sulfate alone.

The financial profile is therefore characterized by high unit volume, low average selling prices, limited pricing power, and relatively modest gross-margin opportunity unless a supplier controls a scarce API source, has an efficient extended-release platform, or holds a strong retail distribution position.

What is driving the financial trajectory for pseudoephedrine sulfate?

Seasonal respiratory demand

Demand rises during winter respiratory-virus seasons and during periods of elevated allergy activity. The product is a symptom-treatment category, so demand is linked to consumer illness and environmental conditions rather than to chronic therapy adherence.

Seasonality creates working-capital and inventory-management pressure. Manufacturers and retailers must build inventory before peak demand, while a weak respiratory season can produce markdowns or lower production utilization.

Regulatory purchase limits

The Combat Methamphetamine Epidemic Act limits retail sales of pseudoephedrine products and requires transaction records, purchaser identification, daily and monthly quantity limits, and secure placement. Federal limits include 3.6 grams per purchaser per day and 9 grams per purchaser during a 30-day period for non-mail transactions, subject to statutory rules and exceptions. States may impose stricter requirements. [1]

These rules reduce impulse purchases and restrict distribution convenience. They also increase retailer compliance costs and make shelf availability less visible than for ordinary OTC products.

Retailer access

Retailers determine whether pseudoephedrine is stocked, how many package sizes are offered, and whether purchases are processed through a pharmacist or controlled-sales system. Large chains can maintain compliance infrastructure, while smaller retailers may reduce or eliminate inventory because of administrative burden, theft risk, or low turnover.

Availability is a commercial differentiator. A manufacturer with dependable wholesaler and pharmacy distribution can capture volume even without brand premiums.

Substitution risk

Pseudoephedrine sulfate competes with:

Pseudoephedrine hydrochloride products.
Oral phenylephrine products.
Oxymetazoline and other topical nasal decongestants.
Combination products containing antihistamines, analgesics, or cough suppressants.
Non-drug allergy therapies.

The FDA proposed removing oral phenylephrine as an OTC nasal-decongestant active ingredient after concluding that available data did not support effectiveness at the permitted monograph dose. The proposal did not remove pseudoephedrine from the market, and pseudoephedrine remains the principal oral decongestant alternative in U.S. pharmacy channels. [2]

What is the FDA regulatory status of pseudoephedrine sulfate?

Pseudoephedrine sulfate is regulated as an OTC nasal decongestant active ingredient under the FDA’s OTC monograph framework and related regulations. Oral nasal decongestant products must comply with applicable dosage, labeling, warnings, and combination-product requirements. The relevant OTC framework is principally found in 21 C.F.R. Part 341. [3]

Pseudoephedrine products are not freely displayed like ordinary OTC analgesics. Federal law requires controlled retail handling, but the product generally remains nonprescription.

FDA status summary

Question	Answer
Is pseudoephedrine sulfate FDA-recognized for OTC use?	Yes, subject to applicable monograph and labeling requirements
Is a new drug application generally required for a compliant monograph product?	No, not where the product meets the applicable OTC requirements
Is pseudoephedrine federally prescription-only?	No
Is it sold unrestricted on open shelves?	No, federal controls require regulated retail handling
Is it subject to Drug Facts labeling?	Yes
Is it an Orange Book product category?	Generally no, because ordinary OTC monograph products are not listed like approved prescription drugs

The FDA’s OTC monograph reforms under the CARES Act changed the legal structure for many nonprescription products, but they did not create patent exclusivity for a mature ingredient. A manufacturer must comply with the applicable monograph, labeling, manufacturing, and registration requirements.

What patents protect pseudoephedrine sulfate?

The core pseudoephedrine sulfate molecule is an old active pharmaceutical ingredient. Composition-of-matter patent protection has expired. No commercially important U.S. patent barrier is generally associated with the basic pseudoephedrine sulfate molecule.

Potentially relevant IP can still arise from:

Extended-release matrices.
Abuse-deterrent or tamper-resistant dosage forms.
Combination products.
Manufacturing or purification processes.
Tablet coatings and controlled-release systems.
Packaging and dispensing systems.

These rights protect particular products or processes, not the underlying active ingredient across the market.

Patent-estate assessment

Patent category	Current commercial relevance
Pseudoephedrine sulfate composition patent	No meaningful remaining exclusivity expected
Standard immediate-release tablet	Generally open to generic competition
Extended-release formulation	Potentially protected by formulation or method patents, depending on product
Combination cold product	Product-specific patents may exist, but many claims are expired or narrow
Manufacturing process	Possible confidential know-how or process patents
Packaging and anti-abuse technology	Potentially relevant to selected products
Orange Book-listed patent	Not generally applicable to ordinary OTC monograph products

When does pseudoephedrine sulfate lose exclusivity?

Pseudoephedrine sulfate has already lost exclusivity at the active-ingredient level. The market does not depend on a forthcoming patent-expiration event.

There is no standard Hatch-Waxman launch date comparable to a branded prescription drug because ordinary OTC monograph products do not rely on a single innovator NDA with an Orange Book patent term. A company entering the market typically competes through a compliant OTC product, an abbreviated regulatory pathway where applicable, private-label supply, or a differentiated formulation.

This distinction matters for investors. A patent-expiration model can materially overstate opportunity if it assumes a large branded pseudoephedrine product will suddenly face generic entry. The product is already structurally generic.

Are there Paragraph IV challenges involving pseudoephedrine sulfate?

Paragraph IV litigation is not the principal competitive mechanism for ordinary pseudoephedrine sulfate OTC products. Paragraph IV certifications apply to abbreviated new drug applications that reference listed drugs and challenge Orange Book patents. Most conventional pseudoephedrine sulfate products are sold under the OTC monograph system rather than through an Orange Book-centered prescription-drug framework.

A Paragraph IV dispute could arise for a particular approved extended-release or combination product if it has Orange Book-listed patents. That would be product-specific and would not establish broad exclusivity for pseudoephedrine sulfate as an active ingredient.

What is the Orange Book status of pseudoephedrine sulfate?

The Orange Book is not a comprehensive registry of all OTC monograph products. A standard pseudoephedrine sulfate OTC product generally does not have an Orange Book patent listing or regulatory exclusivity period comparable to an approved prescription product. [4]

The relevant commercial questions are instead:

Whether the formulation complies with the OTC monograph.
Whether the manufacturer has lawful access to API.
Whether the dosage form has formulation IP.
Whether the product meets Drug Facts and warning requirements.
Whether the retailer will stock and process controlled sales.

What manufacturing and supply-chain barriers affect pseudoephedrine sulfate?

Pseudoephedrine is a regulated precursor chemical. Manufacturers, distributors, and retailers face additional recordkeeping, security, reporting, and transaction-control obligations under federal and state law. These requirements raise compliance costs and can limit the number of willing suppliers.

The major manufacturing risks are:

API sourcing and precursor controls.
Regulatory audits and transaction monitoring.
Quality failures involving assay, dissolution, impurities, or content uniformity.
Seasonal demand forecasting.
Retailer-specific packaging and compliance requirements.
Shortages caused by production interruptions or allocation decisions.

The API itself is not technologically difficult compared with complex biologics or high-potency oncology compounds. The barrier is regulatory control and supply-chain execution rather than molecular complexity.

How does pseudoephedrine sulfate compare with pseudoephedrine hydrochloride?

Attribute	Pseudoephedrine sulfate	Pseudoephedrine hydrochloride
Active moiety	Pseudoephedrine	Pseudoephedrine
Common use	Oral decongestant	Oral decongestant
Patent position	Mature, generic	Mature, generic
U.S. retail controls	Behind the counter	Behind the counter
Dose comparison	Must account for salt form	Must account for salt form
Main competition	HCl products and other decongestants	Sulfate products and other decongestants
Differentiation	Release profile, tablet design, packaging, supply	Release profile, tablet design, packaging, supply
Strategic advantage	Product-specific availability or formulation	Broad supplier and retailer familiarity

The salt form is usually less important commercially than the finished product’s dose, duration, packaging, price, and retail availability.

What generic launch scenarios exist for pseudoephedrine sulfate?

The most likely launch scenarios are incremental rather than disruptive.

Immediate-release private-label entry

A contract manufacturer supplies a retailer or wholesaler with a monograph-compliant tablet. Success depends on low manufacturing cost, reliable API supply, and retailer authorization.

Extended-release formulation entry

A supplier launches a 12-hour or other modified-release product. This can support higher margins, but formulation development, bioequivalence, dissolution control, and possible product-specific patents increase risk.

Combination-product entry

Pseudoephedrine is combined with an antihistamine, analgesic, or cough suppressant. Combination products can increase basket value, but they also increase labeling, quality, and formulation complexity.

Geographic expansion

U.S. state restrictions and international precursor controls limit simple geographic scaling. Canada, Europe, and other markets have different rules for pseudoephedrine access, dispensing, and combination products. A formulation approved in one market cannot be assumed to qualify in another.

Which companies are exposed to pseudoephedrine sulfate revenue?

Revenue exposure is distributed across API manufacturers, generic drug companies, contract manufacturers, pharmacies, wholesalers, and consumer-health businesses. Public-company disclosure rarely isolates pseudoephedrine sulfate revenue, so company-specific exposure cannot be ranked reliably from financial statements alone.

Large consumer-health companies may sell pseudoephedrine-containing brands or combination products, while generic manufacturers supply store brands and pharmacy-label products. Retailers may earn more from category traffic and combination-product purchases than from the active ingredient itself.

The category is therefore a low-transparency revenue segment. Its financial importance is usually material only within a broader OTC portfolio, not as a standalone reporting line.

What patent litigation and settlement risks affect the market?

Broad patent litigation risk is low for immediate-release pseudoephedrine sulfate. Litigation risk is higher for:

Extended-release products.
Combination products with branded formulation patents.
Abuse-deterrent delivery systems.
Manufacturing processes.
Trade secrets involving API purification or release-control technology.

Settlement agreements are not a central market feature for the basic sulfate product. Any settlement involving a branded combination or extended-release product would generally affect that product’s launch timing, not the entire pseudoephedrine sulfate market.

Key Takeaways

Pseudoephedrine sulfate is a mature, generic OTC decongestant with no meaningful composition-of-matter exclusivity.
U.S. sales are controlled behind the counter under the Combat Methamphetamine Epidemic Act.
Financial performance depends on seasonal demand, retailer access, API supply, compliance costs, and private-label volume.
No reliable public financial disclosure isolates pseudoephedrine sulfate revenue.
The Orange Book and Paragraph IV frameworks have limited relevance to ordinary OTC monograph products.
Formulation, combination-product, manufacturing, and packaging patents may protect individual products but do not create broad active-ingredient exclusivity.
Pseudoephedrine hydrochloride is the principal salt-form competitor, with similar regulatory and commercial economics.
The strongest commercial opportunities are operational: reliable supply, compliant distribution, efficient formulation, and retailer access.

FAQs About Pseudoephedrine Sulfate

Is pseudoephedrine sulfate still commercially available in the United States?

Yes. It remains available in compliant OTC products, but federal law requires regulated retail handling and purchaser controls.

Does pseudoephedrine sulfate require a prescription?

Generally no. It is nonprescription federally, although state laws and retailer policies can impose stricter procedures.

Is pseudoephedrine sulfate more valuable than pseudoephedrine hydrochloride?

Not inherently. Commercial value depends on dosage form, release profile, supply reliability, formulation cost, and distribution rather than the salt name alone.

Can a company launch a generic pseudoephedrine sulfate tablet without challenging a patent?

Generally yes, if the product complies with the applicable OTC regulatory framework and does not infringe valid product-specific patents.

Is pseudoephedrine sulfate affected by the FDA’s action on oral phenylephrine?

No direct removal has occurred for pseudoephedrine sulfate. The FDA’s action concerning oral phenylephrine relates to that separate active ingredient and does not eliminate pseudoephedrine from the OTC market.

References

U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Pub. L. No. 109-177, Title VII.
U.S. Food and Drug Administration. (2023). FDA proposes to withdraw approval of oral phenylephrine as an over-the-counter nasal decongestant.
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. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	8
DailyMed Link:	PSEUDOEPHEDRINE SULFATE at DailyMed

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