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
Dr Reddys Labs Ltd	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	090619-001	Jul 8, 2009		OTC	No	No
Perrigo R And D	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	079113-001	Dec 22, 2008		OTC	No	No
Aurobindo Pharma	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	216204-001	May 31, 2022		OTC	No	No
Pld Acquisitions Llc	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	diphenhydramine citrate; ibuprofen	TABLET;ORAL	211404-001	Apr 11, 2024		OTC	No	No
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005		OTC	Yes	Yes

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

DIPHENHYDRAMINE CITRATE; IBUPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Diphenhydramine and Ibuprofen

Introduction to Diphenhydramine and Ibuprofen

Diphenhydramine and ibuprofen are two widely used medications with distinct therapeutic applications. Diphenhydramine is a first-generation H1-antihistamine, known for its antihistamine and sedative effects, while ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, fever, and inflammation.

Diphenhydramine Market Dynamics

Market Size and Growth

The diphenhydramine market is projected to reach USD 0.99 billion in 2024 and is expected to grow at a CAGR of 2.30% to reach USD 1.10 billion by 2029[1].

Regional Market Share

North America holds the largest market share for diphenhydramine, while the Asia-Pacific region is the fastest-growing market. This growth in Asia-Pacific is driven by increasing healthcare expenditures and a rising population suffering from allergies and other conditions treated by diphenhydramine[1].

Key Drivers

• Increasing Allergic Populations: The growing number of people suffering from seasonal allergies and other allergic conditions is a significant driver for the diphenhydramine market.
• Rising Prevalence of Motion Sickness and Insomnia: These conditions also contribute to the demand for diphenhydramine.
• Research and Development: Increased R&D expenditures in the pharmaceutical sector further boost the market's growth[1].

Major Players

Key players in the diphenhydramine market include Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd.[1].

Ibuprofen Market Dynamics

Market Size and Growth

The global ibuprofen market was valued at USD 1.43 billion in 2023 and is expected to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44% during the forecast period[3].

Regional Market Share

Asia-Pacific is the largest market for ibuprofen, driven by cost-efficient manufacturing in countries like China and India. North America is the fastest-growing region due to rising public awareness of chronic diseases and increasing healthcare spending[3].

Key Drivers

• Rising Urbanization: Increasing urbanization and public awareness of chronic diseases such as rheumatoid arthritis, osteoarthritis, and cardiovascular disease drive the demand for ibuprofen.
• Healthcare Spending: Growing healthcare expenditures, particularly in the Asia-Pacific region, contribute to the market's growth.
• Self-Medication Trends: The trend toward self-medication for minor ailments also boosts the demand for ibuprofen[3].

Financial Trajectory of Diphenhydramine

Price Volatility

The prices of diphenhydramine hydrochloride experienced a decline in late 2023 due to reduced demand from the pharmaceutical and healthcare sectors, particularly in China and the Eurozone. However, prices are expected to increase at the beginning of FY24 due to renewed demand and potential restocking by market participants[4].

Economic Factors

• Deflationary Pressures: Deflation in China and reduced consumer spending in key overseas markets like the USA and Europe impacted the demand for diphenhydramine.
• Interest Rates: High-interest rates in the Eurozone and other regions have led to decreased consumer spending and business investments, affecting the market[4].

Financial Trajectory of Ibuprofen

Market Growth Projections

The ibuprofen market is expected to grow steadily, driven by increasing healthcare expenditures and public awareness of chronic diseases. The Asia-Pacific region, particularly countries like China and India, will continue to be significant contributors to this growth due to their cost-efficient manufacturing capabilities[3].

Economic Factors

• Healthcare Expenditures: Rising healthcare benefit costs in the Asia-Pacific region, which increased from over 5% in 2020 to nearly 8% in 2021, support the growth of the ibuprofen market.
• Demographic Changes: An aging population, especially in India, where the number of people over 60 is expected to increase significantly by 2031, will also drive the demand for ibuprofen[3].

Competitive Landscape

Diphenhydramine

The diphenhydramine market is moderately concentrated, with several major players competing for market share. These companies focus on research and development to enhance product offerings and expand their market presence[1].

Ibuprofen

The ibuprofen market is highly competitive, with multiple players operating globally. The market is driven by cost-efficient manufacturing, particularly in the Asia-Pacific region, and by trends toward self-medication and increasing healthcare spending[3].

Regulatory and Safety Considerations

Diphenhydramine

Diphenhydramine has several side effects, including sedation, dry mouth, and potential deliriant effects at higher doses. Its use can also lead to QT prolongation and cardiac arrhythmias. There is no specific antidote for diphenhydramine toxicity, but supportive treatments like physostigmine and benzodiazepines can be used[2].

Ibuprofen

Ibuprofen is generally safe when used as directed but can have side effects such as gastrointestinal issues, allergic reactions, and increased risk of cardiovascular events. Regulatory bodies closely monitor the safety and efficacy of ibuprofen products to ensure compliance with safety standards[3].

Consumer Demand and Trends

Diphenhydramine

Consumer demand for diphenhydramine is driven by the increasing prevalence of allergic conditions and the need for effective sleep aids. The availability of diphenhydramine under various brand names, such as Benadryl and Nytol, also influences consumer choice[2].

Ibuprofen

Consumer demand for ibuprofen is driven by the need for over-the-counter medications for minor ailments like headaches, fever, and pain. The trend toward self-medication and the availability of ibuprofen in various formulations contribute to its market growth[3].

Key Takeaways

• Diphenhydramine Market: Expected to reach USD 1.10 billion by 2029, growing at a CAGR of 2.30%, driven by increasing allergic populations and research expenditures.
• Ibuprofen Market: Expected to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44%, driven by rising urbanization and healthcare spending.
• Regional Dynamics: Asia-Pacific is a key region for both markets, with North America being a significant market for diphenhydramine.
• Economic Factors: Price volatility and economic conditions such as deflation and high-interest rates impact market dynamics.
• Regulatory and Safety: Both medications have specific safety considerations and regulatory oversight.

FAQs

What is the current market size of the diphenhydramine market?

The diphenhydramine market size is expected to reach USD 0.99 billion in 2024[1].

Which region is the fastest-growing market for diphenhydramine?

The Asia-Pacific region is the fastest-growing market for diphenhydramine[1].

What are the key drivers for the ibuprofen market?

Key drivers include rising urbanization, increasing healthcare spending, and trends toward self-medication for minor ailments[3].

What are the potential side effects of diphenhydramine?

Diphenhydramine can cause side effects such as sedation, dry mouth, and potential deliriant effects at higher doses. It can also lead to QT prolongation and cardiac arrhythmias[2].

How does the competitive landscape differ between the diphenhydramine and ibuprofen markets?

The diphenhydramine market is moderately concentrated, while the ibuprofen market is highly competitive with multiple global players focusing on cost-efficient manufacturing and self-medication trends[1][3].

Sources

1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis.
2. Wikipedia: Diphenhydramine.
3. Straits Research: Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report.
4. ChemAnalyst: Navigating Price Volatility: Global Trends Impacting Diphenhydramine Hydrochloride Market Sentiments.