Last Updated: May 3, 2026

IBU-TAB Drug Patent Profile


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When do Ibu-tab patents expire, and what generic alternatives are available?

Ibu-tab is a drug marketed by Alra and is included in four NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Ibu-tab

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

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  • What is the 5 year forecast for IBU-TAB?
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  • What is Average Wholesale Price for IBU-TAB?
Summary for IBU-TAB
US Patents:0
Applicants:1
NDAs:4

US Patents and Regulatory Information for IBU-TAB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alra IBU-TAB ibuprofen TABLET;ORAL 071058-001 Aug 11, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alra IBU-TAB 200 ibuprofen TABLET;ORAL 071057-001 Aug 11, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alra IBU-TAB ibuprofen TABLET;ORAL 071059-001 Aug 11, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Alra IBU-TAB ibuprofen TABLET;ORAL 071965-001 Aug 11, 1988 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

IBU-TAB Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Market Position of IBU-TAB?

IBU-TAB, an over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen, is used primarily for pain relief, fever reduction, and inflammation. Its global market position factors heavily into its investment viability. As of the latest available data, ibuprofen products generate approximately $2.6 billion annually. The segment is mature but continues to see growth driven by genericization and sustained demand in pain management.

What Are the Production and Supply Chain Dynamics?

Manufacturers of IBU-TAB must ensure consistent sourcing of active pharmaceutical ingredients (APIs), primarily ibuprofen, which is predominantly manufactured in China and India. Supply chain disruptions, such as increased raw material costs or geopolitical tensions, could impact production margins. Patent expirations in key markets have allowed entry by generic competitors, increasing market share for cost-sensitive consumers but lowering per-unit pricing.

What Are the Regulatory and Patent Considerations?

IBU-TAB’s earliest patents expired around 2014 in major markets like the U.S. and EU. Current formulations typically rely on regulatory approvals under generic pathways. The FDA classifies ibuprofen as a well-established, safe OTC ingredient, simplifying regulatory compliance. Ongoing regulatory reviews focus on manufacturing standards and potential new indications, which could influence market expansion.

How Competitive Is the Market?

The NSAID OTC market includes established players like Johnson & Johnson (Motrin), Walgreens, and local generic manufacturers. Price competition is intense, with generics often priced 20–50% lower than branded equivalents. Differentiation is minimal; marketing relies on brand recognition and distribution channels.

What Are the Launch and Expansion Opportunities?

Future growth could derive from new formulations, such as fast-dissolving tablets or combination products. Expanding into emerging markets, where OTC NSAID penetration is rising, offers significant potential. The World Bank reports that OTC analgesic use is increasing in regions like Asia-Pacific and Latin America, projected to grow at 4–6% annually through 2025.

How Does Patent and IP Landscape Affect Investment?

The absence of current patents on standard ibuprofen formulations means high generic competition. Nonetheless, patents on unique delivery systems or combination therapies could provide exclusivity. Vigilance on patent filings related to novel formulations could signal future patentable advantages.

What Are the Pricing and Margin Dynamics?

Wholesale prices for IBU-TAB range between $0.02 and $0.05 per tablet, with retail prices approximately three times higher. Margins depend on production costs, regulatory compliance, and distribution channels. As competition intensifies, profit margins for manufacturers decrease, pushing focus toward operational efficiencies and volume growth.

What Are the Key Risks and Challenges?

  • Price erosion due to generics leads to reduced margins.

  • Supply chain vulnerabilities can affect availability.

  • Regulatory changes, though unlikely, could impose new compliance costs.

  • Market saturation limits growth in developed markets, requiring expansion into emerging regions.

How Do Future Market Trends Drive Investment Decisions?

The OTC segment’s stable demand, combined with incremental innovations, supports steady cash flows. The growing awareness of OTC remedies in emerging economies suggests potential growth. Yet, the high competition and lack of patent protections necessitate focus on cost controls and innovation in delivery formats.

Key Takeaways

  • IBU-TAB holds a mature, low-growth market with strong worldwide demand.
  • Patent expirations have led to a highly competitive environment dominated by generics.
  • Growth opportunities are tied to formulations, geographies, and product differentiation.
  • Supply chain stability and manufacturing efficiencies are critical for profitability.
  • Market expansion into emerging economies offers the most significant upside.
  • Financial margins are declining due to price competition.
  • Regulatory landscape remains favorable but requires ongoing compliance vigilance.

FAQs

1. What is the current patent status of IBU-TAB?
Patents on standard ibuprofen formulations expired between 2014 and 2016 in major markets, enabling generic competition.[1]

2. What are the main competitors in the IBU-TAB market?
Generic manufacturers hold the largest market shares, with brands like Motrin and store-brand equivalents competing primarily on price.

3. Can innovative formulations improve IBU-TAB’s market share?
Yes. Formulations like fast-dissolving tablets or combination therapy products could attract new consumers and differentiate from competitors.

4. How significant are emerging markets for IBU-TAB growth?
Highly significant. Emerging economies are experiencing increasing OTC analgesic demand, with growth rates estimated at 4–6% annually.

5. Are there regulatory barriers for new IBU-TAB formulations?
While standard formulations face minimal barriers, novel delivery methods may require additional clinical data, but approval pathways are generally streamlined owing to ibuprofen’s established safety profile.


Citations

[1] FDA: "OTC Drugs—Final Monograph for Non-Steroidal Anti-Inflammatory Drugs ("NSAID" Monograph)," 2014.

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