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Last Updated: December 18, 2025

MIDOL Drug Patent Profile


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When do Midol patents expire, and what generic alternatives are available?

Midol is a drug marketed by Bayer and Bionpharma and is included in five NDAs.

The generic ingredient in MIDOL 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 Midol

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

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Summary for MIDOL
US Patents:0
Applicants:2
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 5,197
DailyMed Link:MIDOL at DailyMed
Drug patent expirations by year for MIDOL

US Patents and Regulatory Information for MIDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer MIDOL ibuprofen CAPSULE;ORAL 070626-001 Sep 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer MIDOL ibuprofen TABLET;ORAL 071001-001 Sep 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer MIDOL ibuprofen CAPSULE;ORAL 071002-001 Sep 2, 1987 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 MIDOL

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 MIDOL

Last updated: August 5, 2025


Introduction

MIDOL, a well-established over-the-counter (OTC) medication primarily used for the symptomatic relief of menstrual discomforts such as pain, cramps, and bloating, holds a strategic position within the OTC analgesic and women's health markets. Its historical brand recognition, combined with ongoing innovations and market trends, influences its overall market dynamics and financial trajectory. This analysis articulates the key factors shaping MIDOL’s competitive landscape, revenue prospects, and potential for growth within a highly saturated OTC segment.


Industry Overview

The global OTC analgesics market, estimated to be valued at approximately USD 35 billion in 2022, exhibits steady growth driven by consumer preferences for self-medication, aging populations, and increasing awareness of menstrual health management [1]. The menstrual health segment within OTC medications is expanding swiftly, aligning with rising demand for accessible, cost-effective treatments for common menstrual symptoms.

The pharmaceutical landscape for products like MIDOL is marked by intense competition from generics, private labels, and alternative remedies. Brand loyalty, marketing prowess, product efficacy, and safety profiles influence consumer choices significantly. The industry is also heavily regulated, impacting how products are marketed, labeled, and distributed.


Market Dynamics Impacting MIDOL

Consumer Demographics and Market Penetration

MIDOL’s target demographic predominantly includes women aged 15-49 experiencing menstrual discomforts. As awareness of menstrual health issues grows, particularly among younger generations and informed consumers, the demand for effective symptomatic relief solutions increases. Market penetration has historically been strong in North America and Europe; however, emerging markets in Asia-Pacific and Latin America present lucrative growth opportunities due to rising healthcare awareness and increasing disposable incomes.

Regulatory Environment

Regulatory frameworks for OTC products vary globally, influencing manufacturing, formulation, marketing, and sales strategies. In the United States, MIDOL operates under the FDA regulation as an OTC drug, which necessitates compliance with safety, efficacy, and labeling standards. Any regulatory restrictions or changes can significantly impact supply chains and sales trajectories.

Competitive Landscape

MIDOL faces stiff competition from Johnson & Johnson’s Motrin, Advil, and other analgesics, as well as private-label brands. The OTC menstrual pain relief market also includes herbal supplements and alternative therapies, which are gaining consumer traction. Brand differentiation largely hinges on perceived efficacy, marketing, and product innovation—areas where MIDOL continues to invest.

Product Portfolio and Innovation

MIDOL’s product line has expanded beyond traditional caplets to include formulations with added ingredients targeting specific symptoms: MIDOL Complete, MIDOL Teen, and extended-release variants. The company's ongoing R&D efforts aim to improve formulation efficacy, incorporate new delivery systems, and meet consumer preferences for natural or combined relief options.

Distribution Channels

Distribution occurs via pharmacy chains, grocery stores, online platforms, and direct-to-consumer channels. The COVID-19 pandemic accelerated online sales, compelling MIDOL’s marketing strategies to integrate e-commerce and digital advertising. Growth in digital channels is expected to continue as consumers increasingly prefer purchasing health products online for convenience and privacy.


Financial Trajectory and Revenue Outlook

Historical Performance

While specific MIDOL sales data remain proprietary, Johnson & Johnson, its primary corporate underwriter, reports growth in OTC segments driven by macroeconomic factors and product innovation. The OTC analgesics segment has shown resilience, with compounded annual growth rates (CAGR) of approximately 3-4% over the past five years [2].

Revenue Drivers

Key revenue drivers for MIDOL include:

  • Product Innovation: New formulations targeting specific demographics and symptoms.
  • Market Expansion: Penetrating emerging markets in Asia, Latin America, and Africa.
  • Digital Marketing: Leveraging e-commerce to boost sales.
  • Brand Loyalty: Maintaining strong consumer trust through quality assurance and effective marketing campaigns.

Growth Projections

Analysts project that the global OTC menstrual health segment will grow at a CAGR of 5-6% through 2028, fueled by rising awareness and demographic shifts. MIDOL, benefiting from its established market position, could see its revenues follow this trend, with potential for double-digit growth in emerging markets where OTC menstrual pain relief products are underpenetrated.

Challenges and Risks

Potential bottlenecks include regulatory shifts, price competition from generics and private labels, and consumer trends favoring natural remedies over pharmaceutical products. Additionally, patent expirations for proprietary formulations could lead to increased generic competition, impacting MIDOL’s profit margins.


Strategic Opportunities

  • Product Diversification: Developing complementary products such as herbal or natural options or extended-release formulations.
  • Global Expansion: Targeting high-growth regions with tailored marketing strategies.
  • Digital Engagement: Strengthening e-commerce infrastructure and online advertising to capture younger demographics.
  • Regulatory Advocacy: Investing in compliance and advocacy to mitigate regulatory risks.

Conclusion

MIDOL’s market dynamics are multifaceted, shaped by consumer behaviors, regulatory policies, competitive pressures, and innovation trends. Its financial trajectory remains favorable within the OTC vertical, particularly if strategic investments in product development and market expansion are sustained. As the menstrual health space gains global prominence, MIDOL’s ability to adapt to market shifts and consumer preferences will determine its long-term growth prospects.


Key Takeaways

  • The OTC menstrual pain relief segment is expanding at a CAGR of approximately 5-6%, offering growth opportunities for established brands like MIDOL.
  • Market penetration in emerging economies presents substantial upside, driven by increasing health awareness and disposable incomes.
  • Product innovation, especially formulations tailored to specific demographics and symptom profiles, remains essential for maintaining competitiveness.
  • Digital marketing and e-commerce channels are vital growth drivers, especially following accelerated adoption during the COVID-19 pandemic.
  • Regulatory compliance and the mitigation of generic competition are critical risk factors influencing MIDOL’s future profitability.

FAQs

1. How does MIDOL differentiate itself in a crowded OTC menstrual pain relief market?
MIDOL leverages brand recognition, targeted formulations, and marketing campaigns emphasizing efficacy, safety, and tailored symptom relief to differentiate from competitors and private labels.

2. What are the growth prospects for MIDOL in emerging markets?
Emerging markets offer significant opportunities due to rising health awareness, increased disposable income, and limited access to hospital-based treatments. Tailored marketing and distribution strategies will be crucial.

3. How do regulatory changes potentially impact MIDOL’s sales?
Regulatory shifts could impose new labeling, formulation, or marketing restrictions, potentially increasing compliance costs or limiting certain product claims, thereby affecting sales.

4. What innovations could boost MIDOL’s market share?
Innovations such as natural or herbal formulations, extended-release options, and personalized products can attract diverse consumer segments, bolstering market share.

5. How important is digital marketing for MIDOL’s future growth?
Digital marketing is critical, as it enhances direct consumer engagement, boosts online sales, and reaches younger demographics who prefer OTC health products purchased online.


Sources

[1] MarketWatch, "OTC Analgesics Market Size and Trends," 2022.
[2] Johnson & Johnson Annual Report, 2022.

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