Generic IBUPROFEN SODIUM INN equivalents, drug patent expiration information and freedom to operate

Sponsor	Phase
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi	NA
Oman Medical Speciality Board	NA
Hospital for Special Surgery, New York	PHASE3

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	IBUPROFEN SODIUM	ibuprofen sodium	TABLET;ORAL	206581-001	Aug 3, 2015		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	ADVIL	ibuprofen sodium	TABLET;ORAL	201803-001	Jun 12, 2012		OTC	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 11, 2026

Ibuprofen sodium is a nonsteroidal anti-inflammatory drug (NSAID) and a salt formulation of ibuprofen, designed for faster absorption and onset of action compared to standard ibuprofen. Its adoption is driven by demand for improved analgesic and anti-inflammatory medications.

Market Size and Growth Trends

As of 2022, the global NSAID market, including ibuprofen variants, stands around USD 8-10 billion. Ibuprofen sodium's market share remains concentrated within OTC pain relief segments, with an increasing presence in hospital formulations for acute pain management.

Key Market Drivers

Consumer demand for fast-acting analgesics: Patients favor formulations with rapid onset.
Expanding OTC analgesic markets: Growing self-medication trends aid sales of ibuprofen sodium.
Regulatory approvals for new formulations: Enhances market penetration.
Pipeline innovations: Novel delivery forms such as patches and liquids.

Projected Growth

Between 2023 and 2030, the market is forecasted to grow at a compound annual growth rate (CAGR) of approximately 4-6%, driven largely by emerging markets in Asia-Pacific and Latin America. Limited by patent expirations of older ibuprofen products, market expansion focuses on new salt formulations like ibuprofen sodium.

Competitive Landscape

Major players with proprietary formulations or distribution channels include:

Company	Role	Market Share (Estimate)	Notable Products/Strategies
Reckitt Benckiser	OTC dominance	35%	Launch of fast-absorbing formulations
Johnson & Johnson	Diverse analgesics	20%	Expansion into pediatric markets
GlaxoSmithKline	OTC and prescription	15%	New salt variants in pipeline
Others	Niche and regional players	30%	Product innovation and regional expansion

Patent expiries for traditional ibuprofen (~2018-2020) prompted shifts toward salt forms like ibuprofen sodium, which enjoys some patent exclusivity until approximately 2030, depending on jurisdiction.

Regulatory Environment Impact

In the U.S., the Food and Drug Administration (FDA) approved ibuprofen sodium formulations for OTC use in the early 2000s. The European Medicines Agency (EMA) follows similar practices, with registration permits for formulations with enhanced absorption claims.

Key regulatory considerations:

Bioequivalence requirements: Demonstrating faster onset compared to standard ibuprofen.
Safety evaluations: Monitoring for gastrointestinal and cardiovascular risks, consistent with NSAID class effects.

Upcoming regulations aiming to control OTC NSAID doses may influence formulations and marketing strategies.

Financial Performance and Investment Outlook

Limited specific data exists exclusively for ibuprofen sodium's financials. Instead, investor focus centers on the efficacy and commercial success of new formulations. The overall NSAID market's CAGR suggests steady revenue growth, with a segment-specific tilt toward innovative salt forms.

Revenue Estimation (2023)

Estimated OTC sales of ibuprofen sodium: USD 300-500 million globally.
Expected to reach USD 600 million by 2030 with compounded growth.

Investments in R&D by pharma firms leverage their pipeline of salt formulations, clouding some revenue estimates but indicating ongoing interest. Price premiums for fast-acting formulations can range between 10-20% compared to traditional ibuprofen.

Key Risks

Regulatory delays or withdrawn approvals due to safety concerns.
Patent cliff effects leading to generic competition.
Market saturation in mature regions.

Strategic Opportunities

Development of novel delivery forms (e.g., liquids, transdermal patches) to expand market share.
Pursuing differentiated claims, such as faster action or reduced gastrointestinal side effects.
Targeting emerging markets where OTC analgesic demand surges.

Summary

Ibuprofen sodium's market remains a niche within the broader NSAID domain, benefiting from demand for rapid-onset analgesics. Growth prospects hinge on regulatory approvals, product innovation, and geographic expansion. Financial impact remains moderate relative to the overall NSAID market, with projected revenues reaching USD 600 million globally by 2030.

Key Takeaways

The global NSAID market, including ibuprofen sodium, shows steady growth, projected at 4-6% CAGR through 2030.
Ibuprofen sodium's market share is driven by its faster absorption profile, primarily in OTC segments.
Major pharmaceutical firms invest in formulations to extend patent exclusivity and capture emerging market demand.
Regulatory environments influence formulation approvals and safety standards, affecting market deployment.
Revenue estimates for ibuprofen sodium are in the hundreds of millions USD, with expanded formulations and regional growth as key strategies.

FAQs

Q1: How does ibuprofen sodium differ from traditional ibuprofen?
It dissolves faster, resulting in quicker absorption and onset of action, making it suitable for acute pain relief.

Q2: What is the patent status of ibuprofen sodium formulations?
Approximate patent protection extends until 2030 in most jurisdictions, after which generic competition is expected.

Q3: Which regions are expected to lead in ibuprofen sodium adoption?
Asia-Pacific and Latin America are projected to experience higher growth rates due to increasing OTC analgesic markets.

Q4: Are there safety concerns specific to ibuprofen sodium?
No; safety profiles are similar to traditional NSAIDs, but safety monitoring continues for gastrointestinal and cardiovascular risks.

Q5: What innovations could further boost ibuprofen sodium sales?
Development of new delivery systems and combination therapies to enhance efficacy and patient compliance.

References

[1] MarketWatch. "NSAID Market Size, Share & Trends." 2022.
[2] Grand View Research. "NSAID Market Analysis." 2023.
[3] U.S. FDA. "Over-the-Counter Pain Relief Drugs." 2021.
[4] European Medicines Agency. "Regulations on NSAID Formulations." 2022.

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	50
Patent Applications:	144
What excipients (inactive ingredients) are in IBUPROFEN SODIUM?	IBUPROFEN SODIUM excipients list
DailyMed Link:	IBUPROFEN SODIUM at DailyMed

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

IBUPROFEN SODIUM - Generic Drug Details

What are the generic sources for ibuprofen sodium and what is the scope of freedom to operate?

Summary for IBUPROFEN SODIUM

Recent Clinical Trials for IBUPROFEN SODIUM

Pharmacology for IBUPROFEN SODIUM

Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN SODIUM

US Patents and Regulatory Information for IBUPROFEN SODIUM

Ibuprofen Sodium Market Overview and Financial Trajectory