MOTRIN Drug Patent Profile

Which patents cover Motrin, and what generic alternatives are available?

Motrin is a drug marketed by Mcneil, Mcneil Consumer, Mcneil Ped, and J And J Consumer Inc. and is included in six NDAs.

The generic ingredient in MOTRIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Motrin

A generic version of MOTRIN was approved as ibuprofen by STRIDES PHARMA on September 24^th, 1986.

Summary for MOTRIN

US Patents:	0
Applicants:	4
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	207
Clinical Trials:	73
Patent Applications:	4,379
What excipients (inactive ingredients) are in MOTRIN?	MOTRIN excipients list
DailyMed Link:	MOTRIN at DailyMed

See drug sales revenues for MOTRIN

Recent Clinical Trials for MOTRIN

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

Sponsor	Phase
University of Miami	Phase 2
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
Weill Medical College of Cornell University	Phase 4

See all MOTRIN clinical trials

US Patents and Regulatory Information for MOTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mcneil	MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020476-001	May 25, 1995		DISCN	No	No
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994		DISCN	No	No
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-005	May 22, 1985		DISCN	Yes	No
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989		DISCN	Yes	No

Expired US Patents for MOTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994

EU/EMA Drug Approvals for MOTRIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549 Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for MOTRIN

See the table below for patents covering MOTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	127494	Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives
Guatemala	199000066	SUSPENSION FARMACEUTICA ACUOSA PARA ACTIVOS FARMACEUTICOS SUSTANCIALMENTE INSOLUBRES EN AGUA
Canada	2019863	SUSPENSION AQUEUSE PHARMACEUTIQUE POUR DES INGREDIENTS ACTIFS PHARMACEUTIQUES PEU HYDROSOLUBLES (AQUEOUS PHARMACEUTICAL SUSPENSION FOR SUBSTANTIALLY WATER INSOLUBLE PHARMACEUTICAL ACTIVES)
Japan	2874967
Greece	900100481

Supplementary Protection Certificates for MOTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

MOTRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Motrin (Ibuprofen)

Introduction

Motrin, a brand name for the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, is a widely used over-the-counter (OTC) pain reliever. Understanding the market dynamics and financial trajectory of ibuprofen is crucial for stakeholders in the pharmaceutical industry.

Global Ibuprofen Market Overview

The global ibuprofen market is projected to experience steady growth over the coming years. Here are some key statistics:

• Market Size: 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 (2024–2032)[1].
• Regional Dominance: The Asia Pacific region holds the largest share of the ibuprofen market, driven by cost-efficient manufacturing in countries like China and India, and increasing healthcare expenditures[1].

Market Drivers

Several factors are driving the growth of the ibuprofen market:

Rising Urbanization and Healthcare Spending

• Increasing urbanization and rising healthcare spending are significant drivers. As urban populations grow, so does the demand for healthcare services and medications, including OTC pain relievers like ibuprofen[1].

Growing Awareness of Chronic Diseases

• Public awareness of chronic diseases such as rheumatoid arthritis, osteoarthritis, headaches, and cardiovascular disease is on the rise. This increased awareness leads to higher demand for ibuprofen as a treatment option[1].

Self-Medication Trends

• The trend toward self-medication for minor ailments is another key driver. Busy modern lifestyles have led people to opt for quick relief through OTC medications rather than visiting a doctor for minor issues like body aches, menstrual cramps, and joint pain[3].

Demographic Factors

Demographic changes are also influencing the market:

Aging Population

• The growing geriatric population, particularly in countries like India, is a significant factor. For instance, India's aging population is expected to increase from 137.9 million in 2021 to 193.8 million by 2031, driving up the demand for ibuprofen[1].

Competitive Landscape

The competitive landscape for ibuprofen involves several major players:

Key Players

• Companies like Haleon, which owns brands such as Advil (another ibuprofen brand), and Kenvue, are significant players in the OTC pain medication market. These companies have reported strong organic growth and are focusing on portfolio optimization and cost efficiency[2][5].

Financial Performance

The financial performance of companies involved in the ibuprofen market is indicative of the market's overall health:

Revenue Growth

• Haleon reported a 4.1% increase in revenue to £11,302 million in 2023, with organic growth of 8.0% across all categories and regions. The company also saw a 10.4% increase in adjusted operating profit in constant currency[5].

Margin Expansion

• Kenvue reported a gross profit margin of 56.0% for the full year 2023, with an adjusted gross profit margin of 58.4%. This margin expansion was driven by favorable value realization and global supply chain efficiency initiatives[2].

Market Challenges

Despite the growth, the market faces several challenges:

Supply Chain and Cost Inflation

• Companies are dealing with sustained higher cost inflation and foreign currency headwinds, which can impact profit margins. For example, Kenvue faced approximately 110 basis points of foreign currency headwinds in 2023[2].

Regulatory and Market Dynamics

• The market is also influenced by regulatory changes and unique market dynamics. For instance, the suspension of personal care products in Russia and customer inventory reductions affected Kenvue's volume performance in 2023[2].

Future Outlook

The future outlook for the ibuprofen market is positive:

Growth Projections

• The global OTC pain medication market, which includes ibuprofen, is projected to grow at a CAGR of 3.9% from 2024 to 2031, reaching a market size of over $35.50 billion[3].

Regional Growth

• North America is expected to be the fastest-growing region for ibuprofen, although the Asia Pacific region will continue to hold the largest market share[1].

Key Takeaways

• The global ibuprofen market is driven by rising urbanization, increasing healthcare spending, and growing awareness of chronic diseases.
• The trend toward self-medication and the aging population are significant demographic factors.
• Major players like Haleon and Kenvue are focusing on organic growth, portfolio optimization, and cost efficiency.
• The market faces challenges such as cost inflation and foreign currency headwinds but is expected to grow steadily in the coming years.

FAQs

1. What is the current market size of the global ibuprofen market?

   • The global ibuprofen market was valued at USD 1.43 billion in 2023[1].

2. Which region has the largest share of the ibuprofen market?

   • The Asia Pacific region holds the largest share of the ibuprofen market[1].

3. What are the key drivers of the ibuprofen market?

   • Key drivers include rising urbanization, increasing healthcare spending, growing awareness of chronic diseases, and the trend toward self-medication[1][3].

4. How is the aging population affecting the ibuprofen market?

   • The growing geriatric population, especially in countries like India, is increasing the demand for ibuprofen[1].

5. What are the financial performance highlights of major players in the ibuprofen market?

   • Companies like Haleon have reported strong organic growth and margin expansion, while dealing with challenges such as cost inflation and foreign currency headwinds[2][5].

Sources

1. Straits Research - Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report ...
2. Kenvue - Kenvue Reports Full Year and Fourth Quarter 2023 Results
3. GlobeNewswire - Over The Counter Pain Medication Market to Surpass $35.50 Billion by 2031
4. Grand View Research - Ibuprofen API Market Size, Share & Growth Report, 2030
5. Haleon - 2023 Full year results - Haleon