Chlorpheniramine maleate; pseudoephedrine sulfate - Generic Drug Details

What are the generic sources for chlorpheniramine maleate; pseudoephedrine sulfate and what is the scope of patent protection?

Chlorpheniramine maleate; pseudoephedrine sulfate is the generic ingredient in one branded drug marketed by Bayer Healthcare Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for chlorpheniramine maleate; pseudoephedrine sulfate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	chlorpheniramine maleate; pseudoephedrine sulfate at DailyMed

Recent Clinical Trials for chlorpheniramine maleate; pseudoephedrine sulfate

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

Sponsor	Phase
Magna Pharmaceuticals, Inc.	Phase 3

See all chlorpheniramine maleate; pseudoephedrine sulfate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for chlorpheniramine maleate; pseudoephedrine sulfate

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for chlorpheniramine maleate; pseudoephedrine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	CHLOR-TRIMETON	chlorpheniramine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018397-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Chlorpheniramine Maleate and Pseudoephedrine Sulfate

Last updated: February 15, 2026

Overview Chlorpheniramine maleate and pseudoephedrine sulfate are commonly combined in over-the-counter cold and allergy medications. Their market has experienced fluctuations driven by regulatory changes, market demand, and manufacturing trends.

Market Drivers

1. Regulatory Restrictions

   • Pseudoephedrine, a precursor for methamphetamine, has seen tightened regulations globally.
   • The Combat Methamphetamine Epidemic Act of 2005 (United States) limits sales of pseudoephedrine products through record-keeping and sale quantity restrictions.
   • Similar restrictions exist in the European Union and Asian markets, constraining supply and influencing market dynamics.

2. Market Demand

   • The ongoing prevalence of colds, allergic rhinitis, and sinus congestion sustains steady demand.
   • Growing awareness around drug abuse has reduced availability in some regions, but illicit manufacturing persists, impacting legitimate supply chains.

3. Manufacturing and Supply Chain Shifts

   • Some manufacturers reformulate products to replace pseudoephedrine.
   • Non-synthetic alternatives and delivery system innovations (e.g., nasal sprays) are increasingly used, potentially reducing pharmaceutical sales of traditional formulations.

4. Consumer Preference & OTC Transactions

   • Consumers prefer accessible, low-cost medications.
   • Sales are concentrated in North America, Europe, and Asia, with regional regulatory environments shaping product availability.

Market Trends

Year	Global OTC Cold & Allergy Market (USD billion)	Pseudoephedrine-Containing Medications Share (%)	Major Regulatory Events
2018	22.2	45	US limits pseudoephedrine sales
2019	23.4	42	EU reviews pseudoephedrine regulations
2020	25.1	39	COVID-19 increased demand for OTC meds
2021	26.0	36	Shift toward reformulated products
2022	27.2	32	New restrictions in several Asian markets

Source: MarketsandMarkets (2022), Global OTC Market Report.

Financial Trajectory

Revenues and Market Share

While exact revenues for chlorpheniramine/pseudoephedrine formulations are proprietary, estimates suggest:

• The global market for combination antihistamine/decongestant drugs is valued at approx. USD 3.5 billion in 2022.
• Pseudoephedrine-based products account for around 30-40% of the OTC cold and allergy segment, with revenues approaching USD 1.1–1.4 billion.
• Regulatory restrictions and shifts towards alternative formulations have slowed growth rate from a CAGR of approximately 3% (2018–2022) to an estimated 1.5% (2022–2027).

Regulatory Impact on Financials

• Companies with high dependence on pseudoephedrine-containing formulations face revenue headwinds from supply constraints and reformulation costs.
• New formulations and alternative active ingredients may incur increased R&D investments but can open new revenue streams.
• Regional regulatory variability affects profit margins and market access, with North American markets showing stability due to mature regulatory environments.

Competitive Landscape

• Major players include Johnson & Johnson, Teva Pharmaceuticals, and McNeil Consumer Healthcare.
• Patent protections have largely expired, leading to generic prevalence.
• Strategic moves involve reformulations, direct-to-consumer marketing, and expansion into emerging markets.

Future Outlook

Timeline	Key Developments	Impact
2023-2025	Increased regulation and reformulation efforts	Expected decline in pseudoephedrine-based formulations
2024-2026	Introduction of alternative decongestants (phenylephrine)	Potential substitution reduces reliance on pseudoephedrine
2027+	Focus on OTC formulations with minimal regulatory risk	Sustained revenue growth in reformulated products

Risks and Opportunities

• Risks: Stricter regulations, supply chain disruptions, and shifts in consumer preferences.
• Opportunities: Development of non-precursor decongestants, OTC reformulation, and expansion into emerging markets.

Key Takeaways

• The market for chlorpheniramine maleate and pseudoephedrine sulfate faces decline driven by regulatory restrictions on pseudoephedrine.
• Revenues are flattening; CAGR has slowed, with forecasts favoring modest growth in reformulated products.
• Regulatory and supply-chain challenges necessitate strategic adaptation, including reformulation and innovation.
• Competition remains intense with patent expiries and generics dominating; innovation in OTC formulations offers growth potential.
• Regional regulatory landscapes significantly influence regional market dynamics and profitability.

FAQs

1. What regulatory changes have most affected pseudoephedrine sales?
   The US Combat Methamphetamine Epidemic Act (2005) restricts pseudoephedrine sales through purchase limits, record-keeping, and ID verification, significantly reducing OTC availability.

2. Are alternative active ingredients replacing pseudoephedrine?
   Yes, phenylephrine has gained popularity as an OTC decongestant substitute, though its efficacy remains debated.

3. How has COVID-19 impacted the market?
   Pandemic-related increased demand for OTC cold remedies temporarily boosted sales, but supply chain disruptions affected availability and pricing.

4. What does the future hold for reformulated products?
   Reformulations aim to bypass regulatory restrictions, potentially increasing R&D expenditure but opening new revenue streams in compliant formulations.

5. Which regions are most affected by these market dynamics?
   North America experiences the most regulatory restrictions; Asia and Europe are implementing tighter controls, affecting global supply chains and product availability.

References

[1] MarketsandMarkets. (2022). Global OTC Market Report.
[2] U.S. Drug Enforcement Agency. (2005). Combat Methamphetamine Epidemic Act.
[3] European Medicines Agency. (2021). Review of pseudoephedrine regulations.