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Last Updated: December 19, 2025

IBU-TAB Drug Patent Profile


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Which patents cover Ibu-tab, and when can generic versions of Ibu-tab launch?

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-five 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 STRIDES PHARMA INTL on September 24th, 1986.

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Summary for IBU-TAB
US Patents:0
Applicants:1
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 162
Patent Applications: 4,004
DailyMed Link:IBU-TAB at DailyMed
Drug patent expirations by year for IBU-TAB

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alra IBU-TAB 200 ibuprofen TABLET;ORAL 071057-001 Aug 11, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alra IBU-TAB ibuprofen TABLET;ORAL 071059-001 Aug 11, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alra IBU-TAB ibuprofen TABLET;ORAL 071965-001 Aug 11, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 IBU-TAB

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 IBU-TAB

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for over-the-counter (OTC) analgesics, particularly ibuprofen-based formulations like IBU-TAB, has experienced considerable growth driven by increasing demand for effective pain management options. IBU-TAB, a tablet formulation of ibuprofen, is widely used for its anti-inflammatory, analgesic, and antipyretic properties. Analyzing its market dynamics and financial trajectory requires understanding factors influencing demand, competitive landscape, regulatory environment, innovation trends, and overall healthcare industry shifts.

Market Overview

IBU-TAB occupies a significant segment within the global NSAID (non-steroidal anti-inflammatory drug) market. Its popularity stems from ease of administration, established safety profile at recommended doses, and consumer preference for OTC pain remedies. The global ibuprofen market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% from 2023 to 2028, driven by increasing prevalence of pain-related conditions and self-medication trends (source: MarketsandMarkets).

Driving Forces Behind Market Dynamics

  1. Rising Global Demand for OTC Pain Relief

    The increasing incidence of musculoskeletal disorders, dental pain, and fever, especially among aging populations, propels demand for OTC analgesics like IBU-TAB. Consumers favor self-medication for minor ailments, reducing healthcare burdens and promoting OTC sales. In emerging markets, expanding healthcare infrastructure and improving access also contribute to increased consumption.

  2. Consumer Preference for Oral Dosage Forms

    Tablets such as IBU-TAB offer convenience, portability, and predictable dosing, reinforcing their popularity. The ease of integrating these into daily routines supports sustained demand, especially with ongoing health awareness campaigns advocating self-care.

  3. Healthcare Industry Trends and Digital Influence

    Telemedicine expansion and digital health tools facilitate consumer access to information, empowering self-medication for minor symptoms. As a result, OTC analgesics benefit from these shifts, maintaining robust market presence.

  4. Regulatory Landscape

    Regulatory approvals for ibuprofen formulations have generally been favorable, but regulatory agencies impose dose and labeling limitations to minimize adverse effects, such as gastrointestinal complications. Stringent regulations can influence market entry and formulation variations.

  5. Competitive Landscape

    The market features several global players like Johnson & Johnson, Bayer, and Pfizer, offering a variety of ibuprofen-based products. Generic formulations, including IBU-TAB, face stiff price competition but benefit from widespread acceptance and established manufacturing capabilities.

  6. Innovations and Product Differentiation

    Recent development efforts focus on formulation enhancements to improve bioavailability, reduce gastrointestinal side effects, and extend duration of effect. Such innovations could lead to premium pricing strategies and market segmentation.

  7. Public Health Campaigns

    Efforts to educate consumers about proper analgesic use affect demand patterns. While promoting responsible use mitigates risks, it also influences sales channels and marketing approaches.

Financial Trajectory

The financial outlook for IBU-TAB hinges on multiple factors:

  • Market Penetration and Growth Opportunities

    As global OTC analgesic markets expand, IBU-TAB's sales are expected to grow correspondingly. Emerging markets represent substantial growth potential due to rising healthcare literacy and OTC product adoption.

  • Pricing Strategies

    Price elasticity varies by region; premium formulations with added benefits may command higher prices, optimizing margins. Conversely, generic competition topics pressures on pricing, emphasizing cost efficiencies and mass-market strategies.

  • Supply Chain and Manufacturing Cost Trends

    Raw material costs, primarily for active pharmaceutical ingredients (APIs), influence profitability. Price fluctuations in APIs like ibuprofen impact manufacturing costs, necessitating efficient supply chains and strategic sourcing.

  • Regulatory Compliance and Legal Risks

    Strict adherence to safety guidelines and avoiding adverse event liabilities are essential. Regulatory hurdles can delay launches or necessitate reformulations, affecting financial forecasts.

  • Impact of Patent Expirations

    Patent expiry of proprietary formulations leads to increased generic competition, generally exerting downward price pressure but also expanding market size through increased accessibility.

  • Market Share Dynamics

    Established brands' dominance favors steady revenue streams. Market entrants with innovative formulations or targeted consumer segments can challenge incumbents, shifting market share and financial trajectories.

Emerging Trends and Their Financial Implications

  • Personalized Pain Management

    Advances in pharmacogenomics could pave the way for tailored analgesic regimens, influencing future formulations of IBU-TAB and associated revenues.

  • Combination Products

    Co-formulation of ibuprofen with other analgesics or adjuncts may create premium offerings, diversifying revenue streams.

  • Digital Health Integration

    Connectivity features or digital dosing assistance could enhance product appeal, justify premium pricing, and drive sales growth.

Challenges Impacting Market and Financial Performance

  • Safety Concerns

    Gastrointestinal and cardiovascular risks associated with NSAIDs necessitate responsible marketing and may prompt regulatory scrutiny, impacting sales and profitability.

  • Competitive Displacement

    Introduction of novel analgesics or alternative therapies could reduce IBU-TAB’s market share, especially if they offer improved safety profiles or efficacy.

  • Pricing and Reimbursement Policies

    In certain markets, reimbursement models favor prescription drugs, limiting OTC sales growth. Conversely, cost pressure from healthcare payers may necessitate price adjustments.

  • Patent and Market Exclusivity Risks

    Although IBU-TAB formulations are often off-patent, specialized delivery systems or formulations could be protected, influencing competitive dynamics.

Conclusion

The market dynamics for IBU-TAB are shaped predominantly by rising global demand for OTC pain relief, consumer preferences, regulatory frameworks, and competitive forces. Financial trajectories are positive but subject to pricing pressures, regulatory changes, and innovation adoption. Companies investing in formulation improvements, digital engagement, and strategic positioning in emerging markets are likely to benefit from sustained growth.


Key Takeaways

  • The global ibuprofen market, with IBU-TAB as a key product, is projected to grow steadily over the next five years driven by increasing consumer demand and expanding healthcare infrastructure.

  • Market success depends on balancing cost efficiencies with innovation, particularly formulations that enhance safety and efficacy.

  • Regulatory compliance remains a critical factor; companies must adapt to evolving guidelines to mitigate legal and safety risks.

  • Emerging trends such as personalized medicine, digital integration, and combination therapies create opportunities for differentiated offerings and higher margins.

  • Competitive pressures from generics and alternative therapies necessitate strategic planning around patent management, product differentiation, and market expansion.


FAQs

1. How does regulatory regulation affect the sales of IBU-TAB?
Regulatory agencies impose dosing limitations, labeling requirements, and safety warnings on NSAID products like IBU-TAB. Compliance ensures market access but may restrict certain formulations or marketing claims, impacting sales volume and strategy. Additionally, regulatory scrutiny over safety can lead to reformulations or increased production costs.

2. What geographic markets offer the highest growth potential for IBU-TAB?
Emerging markets such as India, China, and Latin American countries present substantial growth opportunities due to expanding middle classes, improved healthcare access, and increasing consumer preference for OTC pain medications. Mature markets like North America and Europe remain stable but face pricing pressures and saturation.

3. How do patent expirations impact IBU-TAB’s financial trajectory?
Patent expirations typically lead to a surge in generic competition, which drives prices downward but increases product accessibility and sales volume. Companies can offset margin declines with higher sales volumes and by launching new formulations or combination products to maintain revenue streams.

4. What innovations are shaping the future of IBU-TAB?
Formulation improvements to reduce gastrointestinal side effects, extended-release versions, and digital health integration for dosing adherence are key innovations. Additionally, combination products with other analgesics or therapeutics can command premium pricing and broaden market reach.

5. How does the consumer shift towards self-medication influence IBU-TAB sales?
The growing tendency for self-medication amplifies demand for OTC analgesics like IBU-TAB. Digital health platforms and telemedicine services further facilitate consumer access to these products. However, this shift also necessitates responsible marketing to prevent misuse and adverse events.


Sources:
[1] MarketsandMarkets. "NSAID Market by Type, Application, and Region—Global Forecast to 2028."
[2] Statista. "Global OTC Pain Relief Market Size & Forecast."

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