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Last Updated: March 26, 2026

IBUPROFEN AND FAMOTIDINE Drug Patent Profile


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When do Ibuprofen And Famotidine patents expire, and when can generic versions of Ibuprofen And Famotidine launch?

Ibuprofen And Famotidine is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Ph Health, Teva Pharms Usa, Torrent, and Zydus Pharms. and is included in seven NDAs.

The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

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Questions you can ask:
  • What is the 5 year forecast for IBUPROFEN AND FAMOTIDINE?
  • What are the global sales for IBUPROFEN AND FAMOTIDINE?
  • What is Average Wholesale Price for IBUPROFEN AND FAMOTIDINE?
Summary for IBUPROFEN AND FAMOTIDINE
US Patents:0
Applicants:7
NDAs:7
Finished Product Suppliers / Packagers: 16
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 8
Patent Applications: 154
What excipients (inactive ingredients) are in IBUPROFEN AND FAMOTIDINE?IBUPROFEN AND FAMOTIDINE excipients list
DailyMed Link:IBUPROFEN AND FAMOTIDINE at DailyMed
Drug patent expirations by year for IBUPROFEN AND FAMOTIDINE
Recent Clinical Trials for IBUPROFEN AND FAMOTIDINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Texas Scottish Rite Hospital for ChildrenPHASE2
Duke UniversityPhase 4
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 4

See all IBUPROFEN AND FAMOTIDINE clinical trials

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 Pharms 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Ibuprofen and Famotidine

Last updated: March 2, 2026

What are the current market sizes and growth trends for ibuprofen and famotidine?

Ibuprofen registers a global market size of approximately USD 4.2 billion in 2023, with an annual compound growth rate (CAGR) of 3%. The growth is driven by widespread use as an over-the-counter (OTC) analgesic and anti-inflammatory agent.

Famotidine reports a global market value near USD 1.3 billion as of 2023, with a 2% CAGR. The market is influenced by recent declines due to safety concerns regarding long-term use of H2 receptor antagonists, but steady demand persists in specific regions, especially for OTC formulations.

Drug 2023 Global Market Size CAGR (2023-2028) Major Market Drivers
Ibuprofen USD 4.2 billion 3% OTC analgesic demand, aging populations, chronic pain management
Famotidine USD 1.3 billion 2% Acid-related disorder treatments, OTC formulations

How do regulatory policies impact sales and R&D investments?

Ibuprofen

  • Approved globally with minimal restrictions for OTC and prescription use.
  • Regulatory policies promote widespread access, particularly in emerging markets.
  • No recent major regulatory hurdles; patent expiration remains a key issue for branded formulations.

Famotidine

  • Market impacted by safety alerts regarding long-term use, primarily in the US and Europe.
  • FDA issued warnings on cancer risk associated with high-dose, long-term famotidine use (2020).
  • Increased regulatory scrutiny prompts a shift towards novel acid suppressants, affecting R&D focus.

What are the key competitive landscape features?

Ibuprofen

  • Dominated by Pfizer (Advil), Johnson & Johnson (Motrin), and generics.
  • OTC availability enhances market penetration.
  • Patent expiry in 2015 triggered a wave of generics, intensifying price competition.

Famotidine

  • Major players include Merck (Pepcid), and several generic manufacturers.
  • Patent expiry in 1999 led to widespread generic competition.
  • Recent interest shifts towards proton pump inhibitors (PPIs) as alternatives.

Which innovation trends influence the future outlook?

Ibuprofen

  • Development of formulations with extended-release profiles.
  • Combination products with other analgesics or anti-inflammatory agents.
  • Focus on pediatric formulations and topical applications.

Famotidine

  • Limited innovation due to safety concerns.
  • R&D interest pivots to safer alternatives, such as PPIs and novel H2 receptor antagonists.
  • Focus on biosimilars and reformulated products offering improved safety profiles.

How do supply chain factors influence market stability?

  • Raw material supply, especially for ibuprofen’s active pharmaceutical ingredient (API), remains stable but sensitive to geopolitical tensions.
  • Famotidine’s raw materials are less volatile; market stability relies heavily on regulatory clarity.
  • Manufacturing consolidation in both markets affects pricing and supply security.

What are the projected financial trajectories over the next five years?

Year Ibuprofen Revenue (USD Billions) Famotidine Revenue (USD Billions) Key Factors
2023 4.2 1.3 OTC sales dominance, patent expiries, safety concerns
2024 4.3 1.2 Generic competition, regulatory adjustments
2025 4.4 1.2 Increased focus on formulations, shift towards alternatives
2026 4.5 1.1 Market saturation, safety alerts impacting famotidine
2027 4.6 1.1 R&D innovation, new product launches

What market risks and opportunities are evident?

Risks:

  • Safety concerns hindering famotidine's growth.
  • Patent expiries eroding branded profit margins for ibuprofen.
  • Regulatory clampdowns on OTC and prescription formulations.

Opportunities:

  • Innovation in topical and pediatric formulations of ibuprofen.
  • Development of safer acid suppression options, reducing reliance on famotidine.
  • Markets in Asia-Pacific and Latin America expanding OTC sales.

Key Takeaways

  • The ibuprofen market is expanding moderately, driven by OTC demand; innovation focuses on formulations and combination products.
  • Famotidine faces decline risks due to safety issues, with a shift towards PPIs and new therapies.
  • Regulatory environment heavily influences market trajectories, emphasizing safety and patent considerations.
  • Generic competition influences pricing and profit margins in both markets.
  • Supply chain stability and raw material access remain critical in maintaining market stability.

FAQs

1. How will patent expiries affect the ibuprofen market?
Patent expiries have allowed generic manufacturers to enter, reducing prices but increasing competition and profits for generics.

2. What safety issues impact famotidine’s market growth?
Concerns over increased cancer risk with long-term use, leading to regulatory warnings and shrinking market share.

3. Are there new formulations in development?
Yes, ibuprofen formulations include extended-release, topical, and pediatric versions. Famotidine R&D is limited due to safety concerns, with focus shifting to alternatives.

4. Which regions hold the highest market potential?
Asia-Pacific and Latin America show high growth potential for both drugs due to increasing OTC access and rising healthcare expenditure.

5. How does regulation shape future R&D?
Stringent safety requirements push companies to innovate safer formulations or alternative compounds, especially impacting famotidine.


References

[1] MarketWatch. (2023). Global analgesics market size.
[2] GlobalData. (2023). Acid-related disorder therapeutics market analysis.
[3] U.S. Food and Drug Administration. (2020). Safety review of histamine-2 receptor antagonists.
[4] IQVIA. (2023). Pharmaceutical market insights.
[5] Grand View Research. (2023). Over-the-counter (OTC) pharmaceutical market analysis.

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