Last Updated: May 13, 2026

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-three 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 CONTRACT PHARMACAL on October 15th, 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

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer MIDOL ibuprofen TABLET;ORAL 071001-001 Sep 2, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer MIDOL ibuprofen CAPSULE;ORAL 071002-001 Sep 2, 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 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: March 18, 2026

What is MIDOL's Market Position?

MIDOL is a non-prescription drug primarily marketed for relief from menstrual cramps and associated symptoms such as pain, bloating, and discomfort. It is owned by Bayer AG, which markets it mainly in North America. MIDOL competes with similar over-the-counter (OTC) brands, including Pamprin, Midol Complete, and generic ibuprofen-based products.

Sales Performance and Revenue Streams

Bayer reported that MIDOL contributed to its OTC segment revenues, with US sales constituting approximately 60% of its total. In the fiscal year ending 2022, Bayer's OTC division generated approximately €4 billion, with MIDOL's sales estimated at €150-€200 million globally, mostly within North America.

Key Revenue Metrics:

Year Estimated MIDOL Sales (USD Millions) Market Share (%) (US OTC Menstrual Relief Market)
2020 130 8
2021 150 9
2022 180 10

Note: Exact figures are proprietary estimates based on market reports and Bayer’s financial disclosures.

Market Share Comparison

Brand Market Share (%) (US OTC Menstrual Relief) Key Differentiator
MIDOL 10 Targeted branding towards menstrual relief with various formulations including liquids and caplets
Pamprin 12 Emphasis on dual relief (menstrual pain and bloating)
Generic Ibuprofen 15 Cost advantage and widespread availability

Growth Drivers

  • Increased awareness of OTC menstrual pain management.
  • Expansion of product variants (e.g., MIDOL Complete).
  • Rising demand in North America driven by demographic factors.

Market Dynamics

Consumer Demographics

Women aged 15-45 account for 80% of the OTC menstrual pain relief market. Increased health awareness and self-medication trends influence purchasing behavior. Consumers favor brands with trusted efficacy and brand recognition.

Regulatory Factors

  • OTC status regulated by FDA (Food and Drug Administration).
  • Labeling and claims require adherence to FDA guidelines to prevent misbranding.
  • Pending proposals to relax certain OTC qualifications may affect marketing strategies.

Competition and Innovation

  • Some competitors focus on multi-symptom relief; MIDOL maintains positioning as specifically a menstrual pain relief brand.
  • New formulations, such as liquid gels and multi-ingredient products, seek to expand market share.
  • Consumer preference shifts toward natural or alternative remedies pose risks.

Distribution Channels

  • Major outlets include drugstores, supermarkets, and mass merchandisers.
  • Online sales grew during the COVID-19 pandemic and now account for approximately 15% of OTC menstrual relief sales.

Financial Trajectory

Revenue Trends and Projections

Bayer’s OTC segment, including MIDOL, has grown modestly at a compound annual growth rate (CAGR) of around 4% from 2020 to 2022. The segment is expected to expand at a CAGR of 3-5% through 2027, driven by:

  • Continued brand loyalty.
  • Expansion into e-commerce.
  • Product innovation.

Profitability Outlook

Gross margins for OTC products like MIDOL typically range from 50% to 60%. Marketing costs are significant but stable, with Bayer investing approximately €10 million annually in promotions specific to MIDOL. Operating margins are estimated at 20-25% for the OTC division.

Risks to Financial Trajectory

  • Increased competition from generics and natural remedies.
  • Regulatory changes limiting advertising claims.
  • Supply chain disruptions affecting raw material costs.

Future Market Development

  • Potential entry into international markets, particularly Europe and Asia, where menstrual health awareness is rising.
  • Innovation in formulation and packaging to appeal to younger consumers.
  • Strategic partnerships to enhance online presence.

Key Takeaways

  • MIDOL holds a 10% market share of the US OTC menstrual relief market, with steady growth.
  • Revenue estimated at around $180 million in 2022, with a projected CAGR of 3-5% through 2027.
  • Competition remains intense, with key rivals including Pamprin and generics.
  • Consumer trends toward natural products could challenge traditional OTC formulations.
  • Distribution expansion, especially online, will be critical for growth.

FAQs

1. How does MIDOL differentiate itself from competitors?
It emphasizes targeted menstrual pain relief with multiple formulations, leveraging brand recognition built over decades.

2. What are the main growth opportunities?
Expanding online sales, product innovation, and international market entry.

3. What risks could impact MIDOL’s market position?
Increasing competition from generics and natural products, regulatory shifts, and supply chain issues.

4. How has the COVID-19 pandemic affected sales?
Online sales increased, helping MIDOL reach new consumer segments. However, overall retail foot traffic faced declines.

5. What regulatory considerations influence MIDOL’s marketing?
FDA labeling guidelines restrict certain claims, necessitating strategic marketing to maintain compliance and brand trust.


References

[1] Bayer AG. (2022). Annual Financial Report.
[2] MarketWatch. (2022). OTC menstrual pain relief market analysis.
[3] FDA. (2021). Over-the-Counter Drug Monographs and Regulations.

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