Last Updated: August 2, 2026

famotidine; ibuprofen - Profile


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What are the generic sources for famotidine; ibuprofen and what is the scope of patent protection?

Famotidine; ibuprofen is the generic ingredient in two branded drugs marketed by Horizon, Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Ph Health, Teva Pharms Usa, Torrent, and Zydus Lifesciences, and is included in eight NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Famotidine; ibuprofen has twenty-five patent family members in fifteen countries.

Summary for famotidine; ibuprofen
International Patents:25
US Patents:5
Tradenames:2
Applicants:8
NDAs:8
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for famotidine; ibuprofen
Paragraph IV (Patent) Challenges for FAMOTIDINE; IBUPROFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUEXIS Tablets famotidine; ibuprofen 800 mg/26.6 mg 022519 1 2011-12-06

US Patents and Regulatory Information for famotidine; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,067,451 ⤷  Start Trial Y ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,501,228 ⤷  Start Trial ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,318,202 ⤷  Start Trial Y ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,309,127 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for famotidine; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 8,501,228 ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 8,067,033 ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 8,309,127 ⤷  Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 8,318,202 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for famotidine; ibuprofen

Country Patent Number Title Estimated Expiration
Austria E539747 ⤷  Start Trial
Australia 2006269894 ⤷  Start Trial
Australia 2007275360 ⤷  Start Trial
Brazil PI0714937 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration
Last updated: February 15, 2026

Investment Scenario and Fundamentals Analysis for Famotidine and Ibuprofen

Overview of Existing Market and Usage

Famotidine and ibuprofen are widely used in the over-the-counter (OTC) and prescription markets. Both drugs generate significant sales volumes. These medications are mature products, with well-established manufacturing and distribution channels.

Market Size and Revenue Estimates

Drug Global Market Size (2022) 2027 Forecast Main Revenue Drivers
Famotidine ~$600 million ~$750 million Treatment of GERD, gastric ulcers; OTC and Rx use
Ibuprofen ~$4 billion ~$4.8 billion Pain relief, fever reduction

Source: Grand View Research, 2022 estimates.

Famotidine sales are driven by its use as an H2 receptor blocker for gastric acid reduction. The market has experienced competitive pressure from PPIs but retains share due to OTC availability.

Ibuprofen remains a core NSAID used for mild to moderate pain. It sees continuous demand from OTC channels and prescription sales for inflammatory conditions.

Patent and Regulatory Status

Famotidine:

  • Patent expiry occurred around 2015 for the original formulation.
  • Generics account for over 90% of sales.
  • No recent major reformulations or new indications; market is mature.

Ibuprofen:

  • Patent expired in the 1980s.
  • Generics dominate the market.
  • Limited scope for reformulation but potential innovations in formulations (e.g., extended-release variants).

Competitive Landscape

  • Famotidine: Dominated by multiple generics; brands like Pepcid have lost exclusivity.
  • Ibuprofen: Highly competitive with numerous OTC brands; no blockbuster brands dominate.

R&D and Patent Opportunities

Few R&D efforts focus on new chemical entities; interest remains in:

  • New formulations to improve bioavailability or reduce side effects.
  • Novel delivery methods (e.g., transdermal patches).

Patent filings are mostly for formulations or methods to extend exclusivity, not for new chemical entities.

Regulatory and Pricing Dynamics

  • Regulatory pressures on OTC labeling, safety warnings.
  • Pricing remains pressured by generics; margins are thin.
  • Potential for expanded indications or combination products could yield new revenue streams.

Investment Risks

  • Market saturation and high generic competition compress profit margins.
  • Regulatory risks around safety warnings or new indications.
  • Limited scope for significant growth without innovation.

Potential Strategic Opportunities

  • Focus on niche formulations or delivery methods.
  • Acquisition of late-stage R&D assets or patent portfolios.
  • Diversification into related therapeutic areas or combination drugs.

Summary

Both famotidine and ibuprofen are mature, low-growth assets with stable demand driven by their wide usage. The key investment consideration hinges on their patent expiration status, generic competition, and potential for incremental innovation. Investment opportunities are limited to niche formulations, patent litigation, or market share expansion through brand differentiation.


Key Takeaways

  • Both drugs operate in mature markets with high generic penetration.
  • Growth prospects are limited but can be enhanced through innovation in formulations.
  • Patent expirations pose significant profitability risks; strategic licensing or acquisition may mitigate these.
  • Regulatory and pricing pressures are persistent, affecting margins.
  • Opportunities lie mainly in niche formulations or combination therapies.

FAQs

1. What is the primary risk in investing in famotidine and ibuprofen?
The main risk is market saturation and high competition from generics, leading to compressed profit margins.

2. Are there opportunities for new formulations or delivery methods?
Yes, incremental innovations such as extended-release or transdermal patches could create niche markets.

3. How does patent expiration influence the market?
Patent expirations increase generic competition, significantly reducing branded drug revenues.

4. What regulatory challenges could impact these drugs?
Regulatory agencies may impose new safety warnings or label changes, affecting marketable sales.

5. Is there potential in developing combination products with famotidine or ibuprofen?
Combination therapies could offer differentiation and new revenue streams, especially if supported by clinical research.


References

  1. Grand View Research. (2022). Pain Management Drugs Market Size.
  2. U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Listings.
  3. IQVIA. (2022). OTC and Prescription Market Data.
  4. European Medicines Agency. (2022). Market Authorization and Post-Marketing Data.
  5. PubChem. (2023). Famotidine and Ibuprofen Chemical Data.

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