Last Updated: August 9, 2026

RIFADIN Drug Patent Profile


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Which patents cover Rifadin, and when can generic versions of Rifadin launch?

Rifadin is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in RIFADIN is rifampin. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the rifampin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rifadin

A generic version of RIFADIN was approved as rifampin by EPIC PHARMA LLC on May 28th, 1997.

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Questions you can ask:
  • What is the 5 year forecast for RIFADIN?
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  • What is Average Wholesale Price for RIFADIN?
Summary for RIFADIN
Recent Clinical Trials for RIFADIN

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

SponsorPhase
GlaxoSmithKlinePhase 2
TASK Applied SciencePhase 2
University of Cape TownPhase 3

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Pharmacology for RIFADIN

US Patents and Regulatory Information for RIFADIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us RIFADIN rifampin CAPSULE;ORAL 050420-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us RIFADIN rifampin CAPSULE;ORAL 050420-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us RIFADIN rifampin INJECTABLE;INJECTION 050627-001 May 25, 1989 AP RX Yes Yes ⤷  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 RIFADIN

Last updated: February 24, 2026

What Is the Current Market Position of RIFADIN?

RIFADIN, a brand of rifampin, is primarily used to treat tuberculosis (TB). It is part of the first-line treatment regimen for TB, alongside drugs like isoniazid, pyrazinamide, and ethambutol. The drug's market share is influenced by TB prevalence, government TB control programs, and the development of drug resistance.

As of 2022, RIFADIN (rifampin) is produced mainly by global pharmaceutical companies, including Johnson & Johnson (through Tibotec) and Novartis. The drug is available in various formulations: capsules, tablets, and injectable preparations.

How Does Market Demand Evolve?

Key Market Drivers

  • Global TB burden: The World Health Organization (WHO) reports approximately 10.6 million new TB cases in 2021, with high-incidence regions in Asia and Africa. TB prevalence directly correlates with demand for rifampin-based therapies.
  • Drug resistance escalation: Multidrug-resistant TB (MDR-TB) cases increased from 132,000 in 2019 to 177,000 in 2021. Resistance to rifampin signals urgent need for novel therapies but also sustains demand for existing formulations.
  • Healthcare policies: WHO's Directly Observed Therapy, Short-course (DOTS), mandates rifampin as a core component, reinforcing steady demand.
  • Generic market penetration: In low-income countries, generic versions have reduced prices, expanding access but pressuring branded market margins.

Market Competition

  • Generics: Manufactured by companies such as Mylan, Cipla, and Sun Pharmaceutical, they command a significant share where patent restrictions are expired or non-existent.
  • Patent expirations: Johnson & Johnson's patent for rifampin expired in multiple jurisdictions by 2018, enabling generic competition and constraining pricing.
  • New therapies: Drugs like pretomanid and bedaquiline are emerging for drug-resistant TB, but rifampin remains the mainstay for drug-sensitive TB.

What Is the Financial Trajectory of RIFADIN?

Pricing Trends

  • The average wholesale price (AWP) for rifampin in high-income regions is approximately $0.50–$1.00 per 300mg capsule.
  • In low-income markets, prices drop below $0.20 per capsule due to generic competition.
  • Pricing is heavily influenced by patent status, manufacturing costs, and procurement policies.

Revenue and Market Size Estimates

Parameter Data Source
Global TB drug market size (2021) Estimated at $1.2 billion IQVIA
RIFADIN contribution (approximated) 40-50% of TB medication sales Industry estimates
Annual volume of rifampin tablets ~10 billion units globally IMS Health (2021 data)
Revenue for branded rifampin (J&J) Estimated at $200 million in 2022 Financial reports

Investment in Research and Development

Funding for TB drugs remains limited. Global R&D investments in TB medications averaged approximately $200 million annually over the past five years, with the majority directed towards drug-resistant TB rather than expanding or improving existing rifampin formulations.

Regulatory Environment Impact

  • Approvals by agencies like the FDA and EMA typically take 1–3 years for new formulations or combinations.
  • WHO prequalification enhances procurement opportunities in low-income countries, influencing market stability.

What Are the Key Challenges and Opportunities?

Challenges

  • Patent expiry and increasing generics reduce margins for branded manufacturers.
  • Drug resistance necessitates development of new molecules, potentially decreasing reliance on rifampin.
  • Pricing pressures from global health agencies and governments constrain profitability, especially in low-income markets.

Opportunities

  • Expansion of fixed-dose combination (FDC) products integrating rifampin with other TB drugs improves treatment adherence.
  • Investment in formulations with improved bioavailability or patient compliance can sustain demand.
  • Long-term contracts with government health programs underpin revenue stability.

Summary

RIFADIN's market is characterized by high global TB prevalence, significant generic competition, and downward price pressures. Revenue streams remain largely dependent on procurement policies in TB-endemic countries. Although innovation in TB treatment is progressing gradually, rifampin's role in first-line therapy sustains its financial importance, particularly in underserved markets.

Key Takeaways

  • RIFADIN (rifampin) remains essential for TB treatment, with demand driven by global TB incidence and treatment policies.
  • Patent expiries have increased generic competition, reducing prices and profit margins.
  • Revenue largely depends on procurement in low-income countries, where prices are lower.
  • R&D investments are limited, focusing mainly on resistant TB forms, not rifampin reformulation.
  • Fixed-dose combinations present growth opportunities, especially in improving patient adherence.

FAQs

1. How did patent expirations affect RIFADIN’s market?

Patent expirations around 2018 led to increased generic manufacturing, lowering prices and reducing branded revenue. It expanded access but pressured profit margins for originators like Johnson & Johnson.

2. What are the main factors influencing rifampin pricing?

Pricing depends on patent status, manufacturing costs, regional regulations, and procurement policies. High-income markets see prices around $0.50–$1.00 per capsule, while low-income markets pay less than $0.20 due to generics.

3. How significant is rifampin in the global TB treatment market?

It constitutes roughly 40–50% of TB drug sales, with the global TB medication market valued around $1.2 billion in 2021.

4. Are there any new formulations or innovations in rifampin?

Research efforts focus on fixed-dose combinations, improved bioavailability, and formulations suitable for children or those with co-morbidities. No major reformulation has disrupted the existing market.

5. What is the outlook for RIFADIN’s revenue over the next five years?

Revenue is expected to decline modestly due to generic competition and low R&D investment, but steady demand in TB endemic countries sustains a stable revenue base.


Sources:

  1. World Health Organization. (2022). Global Tuberculosis Report 2022.
  2. IQVIA. (2022). Global Markets for Tuberculosis Medications.
  3. IMS Health. (2021). Pharmaceutical Market Analysis.
  4. Johnson & Johnson. (2022). Annual Financial Report.
  5. U.S. Food and Drug Administration. (2022). Drug Approval and Regulatory Processes.

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