Last Updated: September 25, 2026

IBUPRIN Drug Patent Profile


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Which patents cover Ibuprin, and when can generic versions of Ibuprin launch?

Ibuprin is a drug marketed by Pliva and is included in one NDA.

The generic ingredient in IBUPRIN is ibuprofen. There is one drug master file entry for this compound. Two hundred and forty-nine suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ibuprin

A generic version of IBUPRIN was approved as ibuprofen by CONTRACT PHARMACAL on October 15th, 1986.

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Questions you can ask:
  • What is the 5 year forecast for IBUPRIN?
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  • What is Average Wholesale Price for IBUPRIN?
Summary for IBUPRIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 162
Patent Applications: 5,049
DailyMed Link:IBUPRIN at DailyMed

US Patents and Regulatory Information for IBUPRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pliva IBUPRIN ibuprofen TABLET;ORAL 071773-001 Jul 16, 1987 DISCN No No ⤷  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

EU/EMA Drug Approvals for IBUPRIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549Treatment 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for Ibuprofen

Last updated: April 4, 2026

Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), remains one of the most widely used over-the-counter (OTC) analgesics globally. Its market is characterized by steady demand, competitive pricing, and diverse manufacturing sources. The following analysis provides a comprehensive view of its current market position, sales trends, regulatory landscape, and future growth potential.

Market Overview

Global Market Size and Growth

The global ibuprofen market was valued at approximately $5.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2028, reaching an estimated $6.7 billion by 2028. Key drivers include increasing demand for OTC pain relief, rising healthcare awareness, and expanding use in pharmaceutical formulations.

Year Market Size (USD billion) CAGR (2023-2028)
2022 5.2 —
2023 5.4 3.8%
2024 5.6 4.2%
2025 5.8 4.2%
2026 6.1 4.2%
2027 6.4 4.2%
2028 6.7 —

Key Regional Markets

  • North America: Largest contributor, driven by OTC sales in the U.S. and Canada. In 2022, North America accounted for about 45% of global sales.
  • Europe: Represents approximately 25%, with growth fueled by aging populations and increased self-medication.
  • Asia-Pacific: Fastest-growing region, with a CAGR of 5.0%.

Major Manufacturers

Leading pharmaceutical companies producing ibuprofen include:

  • Johnson & Johnson (Motrin)
  • Bayer (Advil)
  • Pfizer (Nurofen in some markets)
  • Reckitt Benckiser
  • Local generic manufacturers in emerging markets

Market share is fragmented; top five firms control roughly 55% of supply.

Pricing and Revenue Trends

Average Consumer Price

  • OTC formulations: $0.10 to $0.20 per tablet (depending on dosage and brand).
  • Generic versions: about 30% cheaper than branded counterparts.

Revenue Distribution

  • OTC sales dominate, constituting approximately 80% of total sales.
  • Prescription formulations are a small but growing segment, especially in formulations combined with other active ingredients.

Regulatory Environment

  • FDA (U.S.): Approves OTC status for formulations up to 200 mg per tablet.
  • EMA (Europe): Similar OTC regulations, with some markets permitting higher doses under prescription.
  • Global Trends: Increased regulation of formulations combined with other compounds; stricter controls on dosage and labeling.

Patent and Generic Competition

  • Original patents for branded ibuprofen formulations expired in the early 2000s.
  • Generics entered the market, significantly reducing prices.
  • Recent formulations with enhanced bioavailability or sustained release may have new patent protections, limiting immediate competition.

Future Growth Drivers

  1. Expanding OTC Adoption: Growing consumer preference for self-medication.
  2. Product Innovation: Controlled-release and combination formulations.
  3. Expanding Global Access: Market penetration in developing countries.
  4. Regulatory Approvals: Broadening OTC labels and safe use parameters.

Risks and Challenges

  • Regulatory Changes: Stricter regulations could limit OTC availability.
  • Safety Profile: Concerns about gastrointestinal and cardiovascular adverse effects may impact formulations and labeling.
  • Market Saturation: Mature markets may see slowed growth due to high current penetration.
  • Generic Pricing Pressure: Ongoing price competition from multiple manufacturers.

Financial Outlook

Year Global Revenue (USD billion) Key Factors
2022 5.2 Stable demand, generics dominant
2023 5.4 Slight increase, expanding markets
2025 5.8 Growth driven by emerging market expansion
2028 6.7 Continued growth with product innovation

Key Takeaways

  • The ibuprofen market remains mature but stable, with steady growth driven by OTC sales and expansions into emerging markets.
  • Market fragmentation favors competition, keeping prices competitive.
  • Innovations, particularly in formulations, can influence future revenue streams.
  • Regulatory environments could shift, impacting sales channels and dosing restrictions.
  • Companies engaging in patent protections for new formulations can sustain higher margins.

FAQs

1. How does generic competition affect ibuprofen pricing?
Generic manufacturers offer ibuprofen at reduced prices, compressing profit margins for brand-name producers and lowering consumer costs.

2. What markets are emerging as growth drivers for ibuprofen?
Asia-Pacific and Latin America show the fastest growth, driven by expanding healthcare infrastructure and increasing OTC medication consumption.

3. Are there any recent patent protections for new ibuprofen formulations?
Yes, sustained-release formulations and combinations with other active ingredients have received patent protections, potentially extending exclusivity periods.

4. What safety concerns could impact the market?
Potential gastrointestinal and cardiovascular risks associated with long-term or high-dose use may lead to regulatory restrictions or label warnings.

5. How might regulatory changes impact future sales?
More restrictive OTC policies or stricter labeling could reduce accessible markets, while expanded indications may open new revenue streams.


References

  1. Research and Markets. (2022). Global Ibuprofen Market.
  2. Statista. (2023). Pharmaceuticals: OTC Pain Management.
  3. IMS Health. (2022). Market Trends in NSAIDs.
  4. U.S. Food and Drug Administration (FDA). (2023). Regulatory Updates on OTC Pain Relievers.
  5. European Medicines Agency (EMA). (2022). NSAID Regulation and Market Access.

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