Last Updated: September 28, 2026

IBUPROFEN AND FAMOTIDINE Drug Patent Profile


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Summary for IBUPROFEN AND FAMOTIDINE
US Patents:0
Applicants:7
NDAs:7

US Patents and Regulatory Information for IBUPROFEN AND FAMOTIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211890-001 Aug 3, 2021 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Zydus Lifesciences IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 218684-001 Feb 20, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ph Health IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 203658-001 Mar 22, 2024 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ascent Pharms Inc IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 216814-001 Mar 15, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 219538-001 Jun 30, 2025 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Torrent IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 215925-001 Mar 18, 2024 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva Pharms Usa IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211278-001 Oct 29, 2021 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

Investment Scenario and Fundamentals Analysis for Ibuprofen and Famotidine

Last updated: February 13, 2026

Overview

Ibuprofen and famotidine are established drugs, with broad markets and mature patents. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine-2 blocker, address widespread health conditions. Although their patents have expired or are close to expiration, significant investment opportunities stem from ongoing formulation innovations, generic competition, and emerging markets.

Market Fundamentals

Ibuprofen

  • Market Size: The global NSAID market was valued at approximately $9.7 billion in 2022. Growth is projected at 4.5% annually, driven mainly by pain management and anti-inflammatory indications.
  • Key Players: Major firms include Walgreens Boots Alliance, Teva, and Pfizer.
  • Patent Status: Generic versions dominate post-expiry, with no recent patent protections awarded since the early 2000s.
  • Regulatory Environment: Well-established regulatory pathways; OTC sales account for more than 70% of sales in North America.
  • Innovation: Extended-release formulations and combination products are areas of R&D focus.

Famotidine

  • Market Size: Estimated at $0.9 billion in 2022, with a growth rate of 2% annually.
  • Key Players: Novartis, Mylan, and Teva.
  • Patent Status: Patent expired in 2015; multiple generic versions exist.
  • Regulatory Environment: Strong regulatory framework; OTC availability in the U.S.
  • Innovation: New formulations, such as fast-dissolving tablets, are ongoing.

Investment Considerations

Patent and Competition Landscape

  • Both drugs face intense generic competition; profitability depends on manufacturing efficiency, market share, and distribution channels.
  • Recent patent cliffs have diminished exclusivity; strategic investments should focus on formulation improvements, brand loyalty, or niche indications.

R&D and Formulation Innovation

  • Opportunities exist in developing formulations that improve bioavailability, reduce side effects, or extend patent life.
  • For ibuprofen, sustained-release formulations can differentiate products.
  • For famotidine, alternative delivery methods, like oral disintegrating tablets or combination therapies, have commercial potential.

Regulatory and Market Risks

  • Patents' expiration reduces barriers but increases price competition.
  • Market penetration in emerging markets depends on regulatory approval and local healthcare infrastructure.
  • Potential regulatory challenges, such as adverse events or safety concerns, can impact product uptake.

Investment Strategies

  • Generics and OTC: Focus on companies with optimized manufacturing and distribution.
  • Innovative Formulations: Target firms with R&D pipelines focusing on extended-release or combination products.
  • Emerging Markets: Seek companies expanding geographically in Asia, Africa, or Latin America, where demand growth is robust.

Financial Performance Metrics

Metric Ibuprofen Famotidine
Market Revenue (2022) ~$9.7B ~$0.9B
CAGR (2023-2028) 4.5% 2%
Patent Status No recent patents Patent expired 2015
Typical Gross Margin 50-65% 55-70%
Key Cost Drivers Manufacturing, marketing Manufacturing, R&D

Regulatory Environment Summary

  • OTC status in North America supports high-volume sales but limits pricing flexibility.
  • In emerging markets, regulatory hurdles vary but generally favor fast approval for well-established drugs.
  • Ongoing monitoring of safety alerts and formulary inclusion policies is necessary.

Key Risks and Opportunities

Risks:

  • Price erosion from generics.
  • Regulatory delays or restrictions.
  • Market saturation and declining growth rates.

Opportunities:

  • Formulation improvements extending exclusivity.
  • Entry into untapped markets.
  • Vertical integration in supply chain to reduce costs.

Key Takeaways

  • Both drugs operate in mature, highly competitive markets with dwindling patent protections.
  • Innovation focus, such as extended-release or combination formulations, offers potential for differentiation.
  • Emerging markets present growth opportunities, though regulatory hurdles exist.
  • Cost efficiency and branding are critical to sustain profitability amid price pressures.
  • Strategic investments should weigh long-term patent extension possibilities against sector volatility.

FAQs

1. Is investing in generic versions of ibuprofen and famotidine advisable?
Yes, provided the manufacturing costs are optimized and market share can be secured, as generics dominate sales post-patent expiry.

2. Are there prospects for new patent filings on these drugs?
Limited, due to their age; innovation hinges on formulation improvements rather than new active ingredients.

3. How does regulatory status influence investment?
OTC status supports high-volume sales but limits pricing; emerging markets may require additional regulatory compliance.

4. What are the main growth drivers for these drugs?
Market expansion in developing regions and formulation innovations can sustain or enhance revenues.

5. What factors could negatively impact these investments?
Price competition, regulatory setbacks, and market saturation can erode margins.


Sources:

[1] "Global NSAID Market Report," MarketsandMarkets, 2022.
[2] "Pharmaceutical Market Analysis," IQVIA, 2023.
[3] "Patent Expiry Data," USPTO, 2022.
[4] "Emerging Markets Pharma Growth," WHO, 2022.

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