DIPHENHYDRAMINE CITRATE; IBUPROFEN - Generic Drug Details

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

Diphenhydramine citrate; ibuprofen is the generic ingredient in two branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE CITRATE; IBUPROFEN

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	31
Clinical Trials:	2
DailyMed Link:	DIPHENHYDRAMINE CITRATE; IBUPROFEN at DailyMed

Recent Clinical Trials for DIPHENHYDRAMINE CITRATE; IBUPROFEN

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1

See all DIPHENHYDRAMINE CITRATE; IBUPROFEN clinical trials

Pharmacology for DIPHENHYDRAMINE CITRATE; 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 CITRATE; 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 CITRATE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL PM	Tablets	diphenhydramine citrate; ibuprofen	200 mg/38 mg	021394	1	2017-12-28

US Patents and Regulatory Information for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	216204-001	May 31, 2022		OTC	No	No
Dr Reddys Labs Ltd	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	090619-001	Jul 8, 2009		OTC	No	No
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes
Perrigo R And D	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	079113-001	Dec 22, 2008		OTC	No	No
Pld Acquisitions Llc	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	211404-001	Apr 11, 2024		OTC	No	No

Expired US Patents for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005	8,263,647

Market Dynamics and Financial Trajectory for Diphenhydramine Citrate and Ibuprofen

Last updated: October 16, 2025

Introduction

The pharmaceutical landscape for over-the-counter (OTC) analgesics and antihistamines remains robust, driven by consistent consumer demand for effective symptom relief. Notably, Diphenhydramine Citrate and Ibuprofen stand as two prominent agents with established markets, yet their respective market dynamics and financial trajectories exhibit distinct characteristics shaped by evolving regulatory frameworks, consumer preferences, and competitive pressures. This report provides a comprehensive analysis of the current market landscape, future outlooks, and strategic considerations for stakeholders.

Market Overview

Diphenhydramine Citrate

Diphenhydramine Citrate, an antihistamine developed in the late 1940s, is primarily used for allergy relief, sleep aid, and as an anti-motion sickness agent. Its widespread OTC availability, combined with strong brand recognition, sustains its sales. The global antihistamines market is projected to expand due to rising allergy prevalence, with a CAGR forecast of approximately 4.0% through 2030 [1].

Ibuprofen

Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), originally launched in the 1960s, remains a cornerstone of OTC pain management. Its versatility encompasses analgesic, antipyretic, and anti-inflammatory effects. The NSAID segment alone is anticipated to see a compounded growth rate of about 3.5% over the next decade, supported by increased awareness of self-medication and chronic pain management requirements [2].

Market Dynamics

Demand Drivers

• Chronic and Acute Condition Management: Rising incidence of allergies and pain-related disorders propels demand for both drugs.
• Aging Population: Globally aging demographics increase reliance on OTC medications for managing age-related ailments.
• Consumer Preference for OTC: Growing preference for self-medication reduces healthcare Burden and increases OTC sales.
• COVID-19 Pandemic Impact: Disruptions in healthcare access elevated OTC medication utilization, especially antihistamines and NSAIDs, to manage symptoms at home [3].

Regulatory and Patent Landscape

• Patents and Exclusivity: Both drugs, originally patented decades ago, now depend largely on generic versions, intensifying price competition.
• Regulatory Developments: Regulatory agencies, notably the FDA, continue to update guidelines around NSAIDs and antihistamines, influencing formulations and labeling strategies.
• OTC Reclassification: Moves towards reclassifying certain prescription-only drugs—particularly NSAIDs—for OTC use expand market access but also entail compliance considerations.

Competitive Environment

• Generic Dominance: Market share largely held by generics, leading to price erosion.
• Brand Versus Generic: Established brands maintain loyalty through marketing, though generics capture a significant portion due to affordability.
• Product Innovation: Limited innovation in traditional formulations; however, combination products and novel delivery mechanisms (e.g., rapid-release, liquid gels) aim to differentiate offerings.

Supply Chain Factors

• Raw Material Availability: Supply disruptions of key excipients or active pharmaceutical ingredients (APIs) can impact production costs.
• Manufacturing Capacity: Scale investments and capacity expansions influence market supply and pricing strategies.

Financial Trajectory

Historical Revenue Performance

• Diphenhydramine Citrate: The global antihistamine market measured approximately $4.5 billion in 2022, with diphenhydramine constituting a significant share, especially through products like Benadryl [4].

• Ibuprofen: The broader NSAID segment generated over $6 billion worldwide in 2022, with major OTC brands sustaining steady revenue streams.

Forecasted Growth Trends

• The antihistamine segment is projected to grow at a compound annual growth rate (CAGR) of 4.0%, supported by allergy prevalence and demand for OTC remedies.
• The NSAID segment, including ibuprofen, is expected to grow at approximately 3.5% CAGR, driven by aging demographics and pain management needs.

Pricing Dynamics

• Price Compression: Widespread generic availability exerts downward pressure on unit prices.
• Value-Added Formulations: Companies investing in extended-release or combination products can command premium pricing, impacting revenue streams.

Profit Margins

• Margins in OTC Drugs: Typically range from 20% to 40%, depending on manufacturing complexity, branding, and distribution channels.
• Impact of Regulatory Costs: Compliance and quality assurance expenses influence net profitability.

Investment and Innovation Outlook

• Companies are allocating R&D budgets toward formulating enhanced delivery systems and combination medications—aimed at capturing incremental market share and extending product lifecycle.

Strategic Considerations

Market Expansion

• Geographic expansion into emerging markets with rising allergy prevalence and pain management needs offers lucrative growth avenues.
• Regulatory approvals for new indications or formulations can diversify product portfolios.

Competitive Positioning

• Maintaining brand loyalty through consumer trust and consistent availability remains critical.
• Emphasizing safety profiles, especially in NSAID formulations, can mitigate adverse event perceptions.

Regulatory Navigation

• Staying ahead of evolving guidelines around OTC classifications, labeling, and safety warnings safeguards market access.

Digital and E-Commerce Strategies

• Leveraging digital marketing and direct-to-consumer sales channels can enhance market penetration and consumer engagement.

Conclusion

The markets for Diphenhydramine Citrate and Ibuprofen exhibit moderate but resilient growth trajectories, driven predominantly by demographic shifts, increased self-medication adoption, and broad consumer acceptance. While intense generic competition continues to pressure pricing and margins, strategic innovation, geographic expansion, and regulatory agility remain pivotal for sustained financial performance. Stakeholders that adapt proactively to market shifts—focusing on value-adding formulations, safety claims, and digital outreach—are positioned to capitalize on emerging opportunities.

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Key Takeaways

• Steady Demand: Both drugs benefit from enduring consumer reliance for allergy and pain relief, ensuring consistent revenue streams.
• Generics Dominance: Price compression necessitates innovation and branding strategies to sustain profitability.
• Growth in Emerging Markets: Expanding into regions with rising healthcare awareness can unlock significant growth.
• Regulatory Evolution: Monitoring and adapting to regulatory changes around OTC classifications and safety labeling are essential.
• Innovation and Differentiation: Focusing on delivery mechanisms, combination formulations, and digital marketing enhances competitiveness.

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FAQs

1. What are the primary factors influencing the market growth of Diphenhydramine Citrate?
   Rising allergy prevalence, consumer preference for OTC products, aging populations, and increased self-medication drive market growth for Diphenhydramine Citrate.

2. How does the patent landscape affect the profitability of Ibuprofen?
   Since most formulations are off-patent, generic competition leads to price erosion, compressing profit margins but maintaining high volume sales.

3. What regulatory trends could impact these drugs in the next decade?
   Potential reclassification of certain NSAIDs to OTC, stricter labeling requirements, and safety warnings could alter market access and formulations.

4. Are there significant innovations expected for these drugs?
   Limited traditional innovations, but focus on new delivery systems, combination products, and digital engagement are emerging trends.

5. Which emerging markets offer the most growth potential for these medications?
   Countries in Asia-Pacific, Latin America, and parts of Africa show promising growth due to rising healthcare infrastructure and increased awareness.

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Sources

1. Market Research Future, "Antihistamines Market Analysis," 2022.
2. Allied Market Research, "NSAID Market Forecast," 2022.
3. WHO, "Impact of COVID-19 on OTC Medication Usage," 2021.
4. IMS Health, "Global OTC Medicine Market Data," 2022.