Diphenhydramine hydrochloride; ibuprofen - Generic Drug Details

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

Diphenhydramine hydrochloride; ibuprofen is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma Ltd, Bionpharma, and Onesource Specialty, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride; ibuprofen

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	15
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diphenhydramine hydrochloride; ibuprofen
DailyMed Link:	diphenhydramine hydrochloride; ibuprofen at DailyMed

Recent Clinical Trials for diphenhydramine hydrochloride; ibuprofen

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
HALEON	Phase 1

See all diphenhydramine hydrochloride; ibuprofen clinical trials

Pharmacology for diphenhydramine hydrochloride; ibuprofen

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

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

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
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

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

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Capsules	diphenhydramine hydrochloride; ibuprofen	200 mg/25 mg	021393		2016-02-16

US Patents and Regulatory Information for diphenhydramine hydrochloride; ibuprofen

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	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005		OTC	Yes	Yes
Bionpharma	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	090397-001	Nov 22, 2010		OTC	No	No
Aurobindo Pharma Ltd	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	210676-001	Feb 14, 2019		OTC	No	No
Onesource Specialty	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	200888-001	Mar 5, 2012		OTC	No	No

Expired US Patents for diphenhydramine hydrochloride; ibuprofen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005

Market Dynamics and Financial Trajectory for Diphenhydramine Hydrochloride and Ibuprofen

Last updated: October 16, 2025

Introduction

The global pharmaceutical landscape for over-the-counter (OTC) analgesics and antihistamines continues to evolve, driven by changing consumer preferences, regulatory shifts, and innovative product developments. Among the most prominent drugs in this sphere are Diphenhydramine Hydrochloride and Ibuprofen, both of which enjoy widespread use for allergy relief and pain management, respectively. Understanding their market dynamics and financial trajectories offers strategic insights for stakeholders, including pharmaceutical firms, investors, and healthcare policymakers.

Market Overview: Diphenhydramine Hydrochloride and Ibuprofen

Diphenhydramine Hydrochloride (commonly marketed as Benadryl) and Ibuprofen are cornerstone OTC medications. Diphenhydramine is an antihistamine used predominantly for allergy symptoms, sedative purposes, and cold relief, while Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) indicated for pain, fever, and inflammation. The combined consumer demand, regulatory environment, and competitive strategies shape their market evolution.

Market Dynamics

Consumer Demand and Usage Trends

Diphenhydramine Hydrochloride:
The demand for diphenhydramine remains robust due to its efficacy in allergy relief and its role as a sleep aid. However, increasing awareness of its sedative side effects and the emergence of alternative antihistamines with more favorable safety profiles, such as loratadine and cetirizine, are impacting its market share. Notably, aging populations in developed markets drive sustained demand for allergy and cold remedies, bolstering diphenhydramine sales despite the rising preference for second-generation antihistamines.

Ibuprofen:
Ibuprofen maintains its position as a leading OTC analgesic, backed by its affordability, efficacy, and widespread availability. Its application extends beyond OTC formulations to prescription drugs for chronic pain management, shaping a broader market footprint. The rising prevalence of musculoskeletal disorders and chronic pain conditions globally sustains demand. Additionally, there's growing consumer preference for NSAIDs with proven safety and proven efficacy, fueling innovation in formulation and delivery mechanisms.

Regulatory Environment and Safety Concerns

Regulatory agencies like the FDA and EMA continuously refine safety standards for both drugs. Recent regulatory reviews—particularly concerning the sedative effects of diphenhydramine and gastrointestinal risks linked to long-term NSAID use—have prompted manufacturers to adapt formulations and labeling. These measures influence market growth, as companies invest in reformulation and risk mitigation strategies to maintain consumer trust and compliance.

Competitive Landscape and Innovation

Market penetration by generic manufacturers has intensified price competition. Key brand names face challenge from store brands and generics, which undercut prices and expand access. Innovation in formulations—such as combining drugs to achieve synergistic effects, or developing non-sedating antihistamines and ultra-rapid-acting NSAIDs—further shapes the competitive landscape. The advent of digital marketing, online sales channels, and telehealth services expands distribution, especially amidst the COVID-19 pandemic’s shift towards e-commerce.

Supply Chain and Manufacturing Considerations

Global supply chain disruptions, notably during the pandemic, have affected raw material availability, impacting production volumes and pricing. Polyethylene glycol derivatives, phenothiazines for antihistamines, and other excipients are subject to geopolitical and environmental factors that influence manufacturing costs and timelines.

Financial Trajectory

Historical Performance and Market Size

Diphenhydramine Hydrochloride:
Historically, the diphenhydramine market has experienced moderate growth, driven predominantly by demands in North America and Europe. The global OTC antihistamines market was valued at approximately USD 4.4 billion in 2020, with diphenhydramine comprising a significant share [1].

Ibuprofen:
The global NSAID market, including ibuprofen, was valued at over USD 12 billion in 2021, with projections indicating compounds such as ibuprofen will grow at a CAGR of around 5% through 2027 [2].

Growth Drivers and Market Expansion

• Demographics: Aging populations in North America, Europe, and parts of Asia increase chronic disease prevalence, expanding analgesic and antihistamine requirements.
• Product Innovation: Enhanced delivery systems, such as fast-dissolving tablets, liquids, and topical formulations, boost market penetration.
• Regulatory Approvals: New indications and formulations, such as combination OTC products or low-dose prescription versions, create revenue streams.

Forecasted Revenue and Profitability

Projections indicate a stable growth trajectory, with opportunities arising from emerging markets in Asia-Pacific, Latin America, and Africa, where OTC drug use is expanding due to urbanization and increased healthcare access. The OTC segment is expected to maintain a CAGR of approximately 4-6% for diphenhydramine and 5-7% for ibuprofen over the next five years.

Challenges and Risks

• Regulatory Scrutiny: Increased safety concerns may result in product label changes, restrictions, or bans, impacting revenues.
• Market Saturation: Intense competition from generics could pressure profit margins.
• Patent Expiry and Generic Competition: The expiration of key patents has accelerated generic entries, significantly reducing prices and profit margins.
• Supply Chain Volatility: Disruptions can lead to increased costs and production delays, hampering sales and profitability.

Investment and Strategic Outlook

Leading pharmaceutical companies are focusing on reformulation, expanding indications, and market diversification to sustain growth. Mergers and acquisitions are prevalent, aiming to consolidate market presence and leverage R&D pipelines. Strategic partnerships with online retailers also enable broader consumer outreach and direct-to-consumer marketing.

Market Influences and Future Trends

Emerging Markets

Rapid urbanization, increasing healthcare expenditure, and rising health literacy fuel OTC drug consumption. Countries like India, China, and Brazil present significant growth opportunities, driven by expanding distribution channels and consumer awareness campaigns.

Digitalization and E-commerce

E-commerce platforms and telemedicine empower consumers to access OTC drugs conveniently. Digital marketing also uncovers new demographics, particularly younger consumers seeking effective, quick-acting remedies.

Personalized Medicine and Formulation Innovation

Advances in pharmacogenomics may lead to tailored formulations, optimizing efficacy and safety for individual patients, further reshaping market dynamics.

Regulatory Developments

Stringent safety assessments may restrict certain uses or formulations, requiring continuous innovation and compliance efforts. Conversely, regulatory approvals for new indications can significantly boost market size.

Key Takeaways

• The global OTC markets for Diphenhydramine Hydrochloride and Ibuprofen are poised for steady growth, driven by aging populations, product innovation, and expanding emerging markets.
• Regulatory scrutiny and safety concerns necessitate ongoing reformulation, which can impact financial trajectories but also open avenues for innovative products.
• The commoditization of these drugs via generics exerts downward pressure on prices, emphasizing the importance of brand differentiation and diversified product portfolios.
• Digital channels will become pivotal for distribution and marketing, especially in the post-pandemic environment.
• Strategic investments in formulation improvements, market diversification, and regulatory compliance are essential for sustained revenue growth.

Conclusion

Diphenhydramine Hydrochloride and Ibuprofen remain critical cornerstones of OTC therapy, with robust market foundations and compelling growth prospects. Navigating regulatory landscapes, embracing technological advancements, and targeting expanding markets will define their financial futures. Stakeholders must remain vigilant to evolving consumer preferences, safety standards, and competitive dynamics to capitalize on emerging opportunities.

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FAQs

1. What are the primary factors influencing the demand for Diphenhydramine Hydrochloride?
   Consumer demand remains driven by allergy relief needs, sedative applications, and cold remedies. However, safety concerns and competition from newer antihistamines influence market share.

2. How does patent expiration affect the profitability of Ibuprofen?
   Patent expiry introduces generic competition, often leading to significant price reductions, which pressure profit margins but also expand market access.

3. Which regions offer the most growth potential for these drugs?
   Emerging markets in Asia-Pacific, Latin America, and Africa present high-growth prospects due to rising healthcare expenditures and increasing OTC drug consumption.

4. What role does innovation play in the future of these drugs?
   Innovations in formulations, delivery methods, and combination therapies enhance efficacy, safety, and consumer appeal, supporting sustained revenue growth.

5. How is digitalization impacting the OTC drug market?
   E-commerce and telehealth facilitate broader access, enabling targeted marketing, and expanding consumer reach, especially among younger demographics.

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References

[1] MarketResearch.com, "Global OTC Antihistamines Market," 2021.
[2] Fortune Business Insights, "NSAID Market Size, Share & Industry Analysis," 2022.