Ibuprofen; pseudoephedrine hydrochloride - Generic Drug Details

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

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, Kenvue Brands, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, Strides Pharma, and Ohm Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for ibuprofen; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	11
Finished Product Suppliers / Packagers:	13
Clinical Trials:	6
DailyMed Link:	ibuprofen; pseudoephedrine hydrochloride at DailyMed

Recent Clinical Trials for ibuprofen; pseudoephedrine hydrochloride

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

Sponsor	Phase
Pharma Medica Research, Inc.	Phase 1
Institut für Pharmakologie und Präventive Medizin	Phase 1
Boehringer Ingelheim	Phase 1

See all ibuprofen; pseudoephedrine hydrochloride clinical trials

Pharmacology for ibuprofen; pseudoephedrine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for ibuprofen; pseudoephedrine hydrochloride

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

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal 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

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT 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 ibuprofen; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	CHILDREN'S ADVIL COLD	ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021373-001	Apr 18, 2002		OTC	No	No
Aurobindo Pharma Ltd	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	213565-001	Mar 10, 2023		OTC	No	No
Aurobindo Pharma	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	209235-001	Dec 1, 2017		OTC	No	No
Contract Pharmacal	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	075588-001	Apr 8, 2002		DISCN	No	No

Expired US Patents for ibuprofen; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	CHILDREN'S MOTRIN COLD	ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021128-001	Aug 1, 2000

Ibuprofen; pseudoephedrine hydrochloride Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Ibuprofen and Pseudoephedrine Hydrochloride?

Market dynamics for both drugs are shaped by regulatory environment, patent statuses, manufacturing constraints, and demand fluctuations driven by health trends and population demographics.

Ibuprofen

Market Size and Growth:
The global over-the-counter (OTC) ibuprofen market was valued at approximately $4.2 billion in 2022, with a compound annual growth rate (CAGR) of 5.2% from 2018 to 2022. Expected to reach $5.6 billion by 2027 (Source: IBISWorld).

Key Factors:

• Market growth driven by increased demand for pain management and anti-inflammatory products.
• Consumer preference for generic formulations reducing pricing pressures.
• Expansion of OTC distribution channels including online platforms.

Regulatory Factors:

• Post-approval regulation in major markets (FDA, EMA) maintains safety standards, impacting manufacturing and formulation.

Competitive Landscape:

• Major players include Johnson & Johnson, Bayer, and Teva Pharmaceuticals.
• Generics dominate, with about 95% market share in mature markets.

Supply Chain Considerations:

• Raw material prices, especially for isobutylbenzene (a precursor), influence production costs.
• Patent expirations facilitate generic entry, impacting brand dominance.

Pseudoephedrine Hydrochloride

Market Size and Growth:
Global demand for pseudoephedrine in medical use was approximately $340 million in 2022, with a CAGR around 3.1%. Growth is modest due to regulatory restrictions and substitution trends (Source: GlobalData).

Regulatory Impact:

• Strict controls due to its use in methamphetamine synthesis.
• Legal limits on sales quantities and prescription requirements vary across jurisdictions.

Market Drivers:

• Ongoing demand for decongestant medications in cold and allergy formulations.
• Shift toward alternative therapies like phenylephrine, which faces less regulatory scrutiny but demonstrates variable efficacy.

Manufacturing Constraints:

• Supply chain focuses on regulated precursor procurement, making production sensitive to enforcement actions and legislation.

Market Concentration:

• Few major suppliers control most of the market, with dual regulation of synthetic precursor production.

How Do Regulatory Environments Affect Market and Financial Trajectory?

Ibuprofen

• Patent expiration timelines (generic versions since early 2000s) promote price competition.
• Regulatory standards for OTC safety lead to consistent reformulation and manufacturing compliance costs.
• No significant restrictions impeding OTC sales, enabling steady revenue streams.

Pseudoephedrine Hydrochloride

• Legislation such as the Combat Methamphetamine Epidemic Act (2005) in the US caps OTC sales, reducing potential revenue.
• Countries implement strict quotas and record-keeping, increasing compliance costs.

What Is the Financial Trajectory for These Drugs?

Ibuprofen

• Revenue growth driven by OTC demand, with stable margins in generics.
• Companies investing in formulations for specific populations (e.g., pediatric, sustained-release) may see incremental revenue.

Pseudoephedrine Hydrochloride

• Market growth constrained by regulatory controls and alternative formulations.
• Revenue remains stable but flat, with potential for decline if substitutes dominate.

Pricing Trends

• Ibuprofen prices have declined due to generic competition.
• Pseudoephedrine prices are stable but subject to regulatory import/export tariffs and supply constraints.

What Are Future Trends and Risks?

• For ibuprofen: Potential reformulation to meet new safety standards, emerging competitors, and market saturation in developed countries.
• For pseudoephedrine: Increased regulation and substitution by other decongestants can restrict or reduce market size.

Key Takeaways

• The global ibuprofen market is sizable, with growth driven by OTC demand and generic competition. Pricing pressures limit profit margins but sustain steady revenue streams.
• Pseudoephedrine transactions are increasingly constrained by regulation, limiting market expansion and controlling revenue.
• Regulatory environments significantly influence manufacturing costs, market accessibility, and product formulation strategies.
• Innovation in formulations and supply chain management could mitigate some regulatory impacts for both drugs.
• Market convergence might result from increased regulation and consumer shift toward alternative therapies, affecting long-term growth.

FAQs

1. How are patent expirations affecting the ibuprofen market?
Patent expirations enable generics to enter the market, increasing competition and reducing prices for ibuprofen. This leads to increased volume sales but lower profit margins for brand-name manufacturers.

2. What regulatory changes could impact pseudoephedrine sales?
Legislation restricting OTC sales, such as quota limits and purchase tracking, constrains potential revenue and increases compliance costs.

3. Are there new formulations for ibuprofen that could impact its market?
Yes, sustained-release, flavored, and pediatric formulations are expanding the market segments, although they face regulatory approval processes.

4. How do market trends in alternative medications affect pseudoephedrine?
Shift toward phenylephrine as a decongestant reduces pseudoephedrine demand, especially where regulatory constraints are strict.

5. What role does geographic diversification play in market stability?
Expanding into emerging markets offers growth opportunities but introduces regulatory complexities that could impact profitability.

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Sources:
[1] IBISWorld. "Ibuprofen Market Report," 2022.
[2] GlobalData. "Pseudoephedrine Market Forecast," 2022.
[3] U.S. Food and Drug Administration. "OTC Drug Monograph: Ibuprofen," 2021.
[4] Combat Methamphetamine Epidemic Act of 2005.
[5] European Medicines Agency. "Regulatory Guidelines for OTC Ibuprofen," 2022.