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 Strides Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	17
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
Strides Pharma	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	200888-001	Mar 5, 2012		OTC	No	No
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

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

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diphenhydramine Hydrochloride and Ibuprofen

Introduction to Diphenhydramine Hydrochloride and Ibuprofen

Diphenhydramine hydrochloride and ibuprofen are two widely used medications with distinct applications and market dynamics. Diphenhydramine hydrochloride is an antihistamine used to treat allergies, motion sickness, and insomnia, while ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and reducing inflammation.

Diphenhydramine Hydrochloride Market Dynamics

Market Size and Growth

The diphenhydramine hydrochloride market is estimated to be valued at 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][3].

Key Drivers

• Increasing Allergic Populations: The rising number of people suffering from seasonal allergies and allergic rhinitis is a significant driver. For instance, approximately 25.7% of US adults reported experiencing seasonal allergies in 2022[1][3].
• Motion Sickness and Insomnia: The growing prevalence of motion sickness among international travelers and the increasing incidence of insomnia due to stress and mental health issues also fuel the market[1][3].
• Research and Development: Increasing R&D expenditures aimed at exploring new applications and formulations of diphenhydramine hydrochloride are expected to boost the market[1][3].

Geographical Distribution

• North America: This region holds the largest market share due to the high burden of allergies and insomnia, as well as the increasing number of international travelers experiencing motion sickness[1][3].
• Asia-Pacific: This region is expected to be the fastest-growing market, driven by the increasing demand for effective medications for allergies and sleep disorders[1].

Market Challenges

• Side Effects: The side effects of diphenhydramine hydrochloride, such as drowsiness and dry mouth, are likely to hinder the market growth[1][3].

Ibuprofen Market Dynamics

Market Size and Growth

The global ibuprofen market is expected to remain in a bullish phase, driven by strong demand from key sectors. However, specific market size projections for ibuprofen are not provided in the sources, but it is noted that the market faces significant pricing pressures due to various factors[2][5].

Key Drivers

• Strong Demand Outlook: Bulk orders for inventory replenishment and increased consumer confidence in downstream sectors have created a demand-supply imbalance, driving up prices[2][5].
• Supply Chain Disruptions: Disruptions in shipping routes, such as those around the Red Sea and the Gulf of Aden, have led to increased freight charges and further exacerbated the supply-demand imbalance[2][5].
• Global Economic Uncertainties: Economic uncertainties, including the impact of interest rate decisions by central banks, add complexity to the market dynamics[5].

Geographical Impact

• North America and Europe: These regions are significantly affected by the global supply chain disruptions and economic uncertainties, leading to price surges in the ibuprofen market[2][5].
• Asia-Pacific: The region also experiences fluctuations in ibuprofen prices due to supply chain challenges and global demand trends[2].

Market Challenges

• Supply Chain Constraints: Insufficient inventories, plant shutdowns, and logistical challenges such as port congestion contribute to the upward pricing pressure[2][5].
• Economic Factors: The Federal Reserve's decision to maintain higher interest rates and the interconnectedness of global trade dynamics further complicate the market[5].

Financial Trajectory for Diphenhydramine Hydrochloride

Current and Projected Market Size

• The diphenhydramine hydrochloride market is valued at USD 0.99 billion in 2024 and is expected to reach USD 1.10 billion by 2029, growing at a CAGR of 2.30%[1][3].

Revenue Growth

• The market is expected to see steady growth driven by the increasing demand for antihistamines and sleep aids. For instance, the diphenhydramine hydrochloride market is projected to grow from USD 279.96 million in 2023 to USD 568.16 million by 2031, at a CAGR of 9.25%[4].

Financial Trajectory for Ibuprofen

Pricing Trends

• The ibuprofen market is experiencing an upward pricing trend due to strong demand, supply chain disruptions, and rising production costs. For example, in North America, the price trend in Q3 2024 was driven by increased global demand and logistical challenges[2][5].

Revenue Impact

• While specific revenue projections are not provided, the market is expected to remain bullish due to continued strong demand. However, the revenue growth may be tempered by the challenges in the supply chain and economic uncertainties[2][5].

Competitive Landscape

Diphenhydramine Hydrochloride

• The market is characterized by strategic collaborations and product innovations by key players such as Fresenius Kabi, Johnson & Johnson, PAI Pharma, Pfizer Inc., and Souvin Pharmaceuticals Pvt. Ltd[1].

Ibuprofen

• The competitive landscape is influenced by major pharmaceutical companies managing supply-demand dynamics and adjusting their strategies to maintain market share amidst global challenges[2][5].

Key Takeaways

• Diphenhydramine Hydrochloride: The market is driven by increasing allergic populations, motion sickness, and insomnia, with North America holding the largest market share and Asia-Pacific being the fastest-growing region.
• Ibuprofen: The market faces upward pricing pressures due to strong demand, supply chain disruptions, and economic uncertainties, affecting regions such as North America and Europe.
• Financial Trajectory: Diphenhydramine hydrochloride is expected to see steady revenue growth, while ibuprofen's revenue is influenced by pricing trends and supply chain challenges.

FAQs

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

The diphenhydramine hydrochloride market is estimated to be valued at USD 0.99 billion in 2024[1][3].

Which region is the fastest-growing for the diphenhydramine hydrochloride market?

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

What are the key drivers of the ibuprofen market?

The key drivers include strong demand outlook, supply chain disruptions, and global economic uncertainties[2][5].

How is the supply chain affecting the ibuprofen market?

Supply chain disruptions, such as those in shipping routes and logistical challenges, are leading to increased freight charges and exacerbating the supply-demand imbalance[2][5].

What is the projected CAGR for the diphenhydramine hydrochloride market from 2024 to 2029?

The diphenhydramine hydrochloride market is expected to grow at a CAGR of 2.30% from 2024 to 2029[1][3].

Sources

1. Mordor Intelligence: Diphenhydramine Market Size & Share Analysis[1]
2. Procurement Resource: Ibuprofen Price Trend, Index, News, Chart, Database[2]
3. Mordor Intelligence: Diphenhydramine Market Size (2024 - 2029)[3]
4. Market Research Intellect: Diphenhydramine Hydrochloride Market Size and Projections[4]
5. ChemAnalyst: Anticipated Surge in Ibuprofen Prices Unfolds Amidst Global Business Dynamics[5]