PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for pseudoephedrine hydrochloride and what is the scope of patent protection?

Pseudoephedrine hydrochloride is the generic ingredient in sixteen branded drugs marketed by Sanofi Aventis Us, Glaxosmithkline, Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Mcneil Cons, J And J Consumer Inc, Kv Pharm, Cenci, Usl Pharma, Newtron Pharms, Pvt Form, Chartwell Rx, Sandoz, Teva, Watson Labs, West Ward, Ivax Sub Teva Pharms, and Superpharm, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for pseudoephedrine hydrochloride. Thirty-one suppliers are listed for this compound.

Summary for PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	16
Applicants:	19
NDAs:	23
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	69
Patent Applications:	2,383
What excipients (inactive ingredients) are in PSEUDOEPHEDRINE HYDROCHLORIDE?	PSEUDOEPHEDRINE HYDROCHLORIDE excipients list
DailyMed Link:	PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

See drug sales revenues for PSEUDOEPHEDRINE HYDROCHLORIDE

Recent Clinical Trials for PSEUDOEPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
John Muir Health	N/A
University of Maryland, Baltimore	Phase 4

See all PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PSEUDOEPHEDRINE HYDROCHLORIDE

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

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

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

US Patents and Regulatory Information for PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mcneil Cons	SUDAFED 12 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	073585-001	Oct 31, 1991		DISCN	No	No
Newtron Pharms	TRILITRON	pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	088474-001	Feb 12, 1985		DISCN	No	No
Teva	TRIPHED	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET;ORAL	088630-001	May 17, 1984		DISCN	No	No
Kv Pharm	TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES	pseudoephedrine hydrochloride; triprolidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	072758-001	Nov 25, 1991		DISCN	No	No

Expired US Patents for PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	4,576,604
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	4,801,461

PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pseudoephedrine Hydrochloride

Introduction to Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride is a sympathomimetic drug belonging to the phenethylamine and amphetamine chemical classes. It is widely used as a nasal decongestant to alleviate nasal congestion in the upper respiratory tract.

Market Size and Growth

The global pseudoephedrine hydrochloride market has been experiencing significant growth. As of 2022, the market size was valued at USD millions, and it is forecasted to expand at a notable CAGR during the forecast period up to 2030[1][5].

Global Market Projections

• The market is expected to reach a substantial value by 2030, driven by increasing demand for decongestants and other pharmaceutical applications.
• The CAGR for the pseudoephedrine market is anticipated to be robust, reflecting the ongoing need for effective nasal decongestants[5].

Market Drivers

Increasing Demand for Decongestants

The decongestants market, which includes pseudoephedrine, is projected to reach $21.3 billion by 2027, growing at a CAGR of 6.3% during the forecast period 2022-2027. This growth is largely driven by the rising incidence of respiratory infections and allergies, which necessitate the use of nasal decongestants[3].

Geographical Dominance

North America holds the largest market share in the decongestants market, accounting for 40% of the overall market in 2021. This region is expected to continue dominating the market due to high sales of decongestants, including those containing pseudoephedrine[3].

Market Challenges

Regulatory Scrutiny

Pseudoephedrine faces regulatory challenges due to its potential for misuse in the production of methamphetamine. This has led to strict regulations and monitoring, which can impact its availability and market growth[2].

Competition from Phenylephrine

Despite its questionable efficacy, phenylephrine remains a popular alternative to pseudoephedrine. Between 2012 and 2021, American pharmacies purchased more units of phenylephrine products than pseudoephedrine products. However, phenylephrine's effectiveness has been widely criticized, and if it is pulled from the market, pseudoephedrine could see increased demand[4].

Side Effects and Health Concerns

Pseudoephedrine is associated with heart-related side effects such as increased blood pressure, palpitations, and tachycardia. These health concerns can hamper the growth of the pseudoephedrine market, as consumers and regulatory bodies become more cautious about its use[3].

Regional Market Analysis

North America

North America is the leading region in the pseudoephedrine market, driven by high demand for over-the-counter decongestants. The U.S. market, in particular, is significant due to the widespread use of pseudoephedrine in various pharmaceutical products[3][5].

Asia Pacific and Europe

Other regions, such as the Asia Pacific and Europe, also contribute substantially to the global pseudoephedrine market. These regions are expected to see steady growth due to increasing healthcare needs and the availability of pseudoephedrine-based products[5].

Application Segments

Medicinal Use

Pseudoephedrine is primarily used in medicinal applications, particularly as a nasal decongestant. Its use in treating respiratory conditions such as colds, allergies, and sinusitis drives a significant portion of the market demand[5].

Stimulant Use

Although pseudoephedrine has stimulant properties, its use for this purpose is heavily regulated due to the risk of misuse. However, it still contributes to the market size, albeit to a lesser extent compared to its medicinal use[5].

Competitive Landscape

The pseudoephedrine market is characterized by several key players involved in pharmaceutical manufacturing. These companies engage in various strategies such as novel product launches, mergers and acquisitions, and R&D activities to maintain their market position[3].

Impact of Global Events

COVID-19 Pandemic

The COVID-19 pandemic has had a mixed impact on the pseudoephedrine market. On one hand, the increased incidence of respiratory infections boosted demand for decongestants. On the other hand, supply chain disruptions and regulatory changes affected the market's overall performance[5].

Economic Factors

Global inflation and regional conflicts, such as the Russia-Ukraine war, have influenced the pseudoephedrine market by affecting raw material costs, production capacities, and distribution channels[5].

Future Outlook

The future of the pseudoephedrine hydrochloride market looks promising despite the challenges. Here are some key points:

• Market Expansion: The market is expected to grow significantly, driven by increasing demand for effective decongestants.
• Regulatory Reforms: There is a need for continued reform of the over-the-counter drug review process to ensure the efficacy and safety of pseudoephedrine and other decongestants[4].
• Innovation: Novel product launches and R&D activities will play a crucial role in the market's growth.

"The FDA needs to hold over-the-counter drugs to a standard of effectiveness similar to that of prescription drugs,” said Timothy Anderson, M.D., M.A.S. “A comparable pathway is needed for drugs that are sold over the counter as exists for post-approval monitoring of the risks and efficacy of prescription drugs."[4]

Key Takeaways

• The global pseudoephedrine hydrochloride market is projected to grow significantly by 2030.
• North America dominates the market, driven by high demand for decongestants.
• Regulatory scrutiny and health concerns are key challenges.
• The market is influenced by global events such as the COVID-19 pandemic and economic factors.
• Innovation and regulatory reforms are crucial for future growth.

FAQs

What is the current market size of the pseudoephedrine hydrochloride market?

The current market size of the pseudoephedrine hydrochloride market was valued at USD millions in 2022 and is expected to expand significantly by 2030[1][5].

Which region dominates the pseudoephedrine market?

North America holds the largest market share in the pseudoephedrine market, accounting for 40% of the overall market in 2021[3].

What are the primary challenges facing the pseudoephedrine market?

The primary challenges include regulatory scrutiny due to its potential for misuse, competition from phenylephrine, and health concerns related to side effects[2][3][4].

How does the COVID-19 pandemic impact the pseudoephedrine market?

The pandemic has had a mixed impact, boosting demand for decongestants but also causing supply chain disruptions and regulatory changes[5].

What are the future prospects for the pseudoephedrine hydrochloride market?

The market is expected to grow driven by increasing demand for effective decongestants, with a need for regulatory reforms and innovation to address current challenges[4][5].

Sources

1. Market Research Reports: Global Pseudoephedrine Hydrochloride Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.
2. Science: The Uselessness of Phenylephrine.
3. IndustryARC: Decongestants Market Size Report, 2022-2027.
4. UPMC: New Study Points to Supply Chain Disruptions.
5. Wicz: Pseudoephedrine (CAS 90-82-4) Market 2032 | by Industry Outlook.