RIFAMATE Drug Patent Profile

When do Rifamate patents expire, and what generic alternatives are available?

Rifamate is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in RIFAMATE is isoniazid; rifampin. There is one drug master file entry for this compound. Additional details are available on the isoniazid; rifampin profile page.

Summary for RIFAMATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	299
Drug Prices:	Drug price information for RIFAMATE
DailyMed Link:	RIFAMATE at DailyMed

See drug prices for RIFAMATE

US Patents and Regulatory Information for RIFAMATE

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	RIFAMATE	isoniazid; rifampin	CAPSULE;ORAL	061884-001	Approved Prior to Jan 1, 1982		DISCN	No	No

RIFAMATE Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 11, 2026

RIFAMATE is a fixed-dose combination of rifampin 300 mg and isoniazid 150 mg used primarily for latent tuberculosis infection. Its commercial outlook is mature and structurally limited: patent and regulatory exclusivity have expired, generic alternatives are available, and treatment guidelines increasingly favor shorter rifamycin-based regimens. RIFAMATE has public-health relevance but limited branded pharmaceutical value. Sanofi does not separately disclose RIFAMATE revenue, so its financial trajectory must be inferred from product status, procurement dynamics, guideline changes, and competition.

What is RIFAMATE and how is it used?

RIFAMATE combines two established anti-tuberculosis agents:

Attribute	RIFAMATE
Active ingredients	Rifampin and isoniazid
Strength	300 mg rifampin / 150 mg isoniazid per capsule
Typical administration	Two capsules once daily under the labeled latent-TB regimen
Primary use	Treatment of latent infection with Mycobacterium tuberculosis
Manufacturer of branded product	Sanofi-affiliated U.S. marketing entity
Regulatory status	Prescription drug
Therapeutic class	Antimycobacterial combination
Commercial category	Mature, low-growth infectious-disease product

RIFAMATE is designed to reduce pill burden compared with prescribing rifampin and isoniazid separately. The combination does not eliminate the need for clinical screening, adherence monitoring, drug-interaction review, or liver-toxicity surveillance.

The product is not a first-line commercial treatment for drug-resistant tuberculosis. Its use is constrained by rifampin interactions, isoniazid hepatotoxicity, resistance considerations, and the availability of alternative latent-TB regimens.

What FDA regulatory status does RIFAMATE have?

RIFAMATE was approved under an older U.S. new drug application framework. Current FDA labeling identifies the product as a prescription fixed-dose combination for latent-TB treatment. Its original regulatory exclusivity expired many years ago because the product and its active ingredients have been marketed for decades.

The principal regulatory characteristics are:

Regulatory factor	Assessment
NDA exclusivity	Expired
New chemical entity exclusivity	Not relevant to this mature product
Pediatric exclusivity	No current commercial significance identified
Orphan exclusivity	Not applicable
REMS	No product-specific REMS identified in current labeling
FDA pathway for competitors	Generic or otherwise abbreviated pathways may be available, subject to FDA requirements
Current commercial barrier	Manufacturing, supply, quality, and procurement execution rather than regulatory exclusivity

The FDA label limits the product’s market to situations where the fixed-dose combination is clinically appropriate. The label also carries warnings related to hepatotoxicity, hypersensitivity, bodily-fluid discoloration, drug interactions, and reduced reliability of hormonal contraceptives during rifampin treatment. [1]

What is the Orange Book status of RIFAMATE?

The Orange Book position is commercially weak. RIFAMATE is an old combination product with no meaningful remaining period of market exclusivity. The relevant commercial question is whether an unexpired patent or regulatory barrier prevents an equivalent product from entering the U.S. market.

No unexpired Orange Book patent is identified as a material barrier to generic competition for RIFAMATE in the current FDA patent-listing framework. The product’s protection is therefore based on its approved labeling and manufacturing capability, not on enforceable exclusivity.

Orange Book issue	RIFAMATE position
Listed reference product	Yes, historically associated with an FDA NDA
Active ingredient patents	Expired
Formulation patents	No material unexpired Orange Book protection identified
Method-of-use patents	No current commercial barrier identified
Patent-term extension	No current relevance
30-month litigation stay exposure	Low
Generic substitution risk	High

The absence of meaningful patent protection makes RIFAMATE vulnerable to substitution by separate rifampin and isoniazid products, as well as by other latent-TB treatment regimens.

What patents protect RIFAMATE?

The original rifampin, isoniazid, and combination-product patent positions have expired. RIFAMATE’s commercial protection does not depend on a modern formulation patent, device patent, biologic manufacturing patent, or proprietary delivery platform.

Potential intellectual-property categories include:

1. Composition patents covering rifampin or isoniazid.
2. Combination patents covering co-administration or fixed-dose capsules.
3. Manufacturing patents covering granulation, blending, or capsule filling.
4. Labeling and method-of-use claims relating to latent-TB treatment.

For RIFAMATE, the first two categories are effectively exhausted. Manufacturing know-how could still affect product quality and supply continuity, but it does not create durable exclusivity comparable with a valid patent estate.

How strong is the RIFAMATE patent estate?

The patent estate is weak from a commercial defense perspective.

Patent-strength factor	Assessment
Remaining patent life	None of material significance identified
Claim breadth	Historically broad, but expired
Design-around risk	High
Generic entry barrier	Low
Manufacturing complexity	Moderate
Litigation leverage	Low
Licensing value	Limited

The product may retain technical know-how value in formulation consistency and regulatory compliance. That value is operational rather than exclusionary.

When did RIFAMATE lose exclusivity?

RIFAMATE lost effective exclusivity decades ago. The active ingredients were developed and commercialized long before the modern Hatch-Waxman exclusivity framework became central to pharmaceutical strategy.

The relevant timeline is:

Period	Event
Pre-1980s	Rifampin and isoniazid established as tuberculosis medicines
Legacy approval period	Fixed-dose rifampin/isoniazid products entered clinical use
1984 onward	Hatch-Waxman created standardized generic-entry procedures
1990s-2000s	Patent-based protection for the underlying actives expired
Current period	Market competition is governed primarily by price, supply, guidelines, and procurement

There is no meaningful future “loss of exclusivity” event comparable with a protected branded drug approaching patent expiry. RIFAMATE is already in the post-exclusivity phase.

Which companies are challenging RIFAMATE?

The principal competitive threat is not a high-profile Paragraph IV campaign. It is substitution by generic manufacturers and public-health procurement systems.

Potential competitors include manufacturers of:

• Rifampin capsules.
• Isoniazid tablets.
• Generic rifampin/isoniazid fixed-dose combinations.
• Rifapentine-based regimens.
• Alternative fixed-dose tuberculosis combinations.

The U.S. market is also influenced by public-sector suppliers and international tuberculosis manufacturers. Major global suppliers of rifampin, isoniazid, and fixed-dose combinations may compete through government tenders rather than traditional branded retail channels.

No material current Paragraph IV litigation campaign against RIFAMATE is identified. That is consistent with the product’s age and lack of meaningful remaining patent protection.

What generic entry risks exist for RIFAMATE?

Generic entry risk is high, but the economic impact is less direct than for a large primary-care brand because RIFAMATE is already a mature, low-volume product.

The main generic-entry scenarios are:

Scenario	Commercial effect
Generic fixed-dose capsule approved	Direct price and volume pressure
Separate generic rifampin and isoniazid used	Erosion of fixed-dose combination demand
Public-health tender substitution	Rapid loss of institutional volume
Supply disruption by a competitor	Temporary branded or authorized-generic opportunity
Guideline shift toward shorter regimens	Structural decline in use

The strongest substitute is not necessarily another fixed-dose capsule. CDC and National Tuberculosis Controllers Association guidance generally favors shorter rifamycin-based regimens for latent TB when clinically appropriate, including three months of weekly isoniazid plus rifapentine, four months of daily rifampin, and three months of daily isoniazid plus rifampin. [2]

These regimens can reduce treatment duration and improve completion rates, although cost, availability, interactions, and patient-specific contraindications determine the actual regimen.

How does RIFAMATE compare with competing latent-TB regimens?

Regimen	Duration	Commercial implication
RIFAMATE, rifampin plus isoniazid	Commonly four months under labeled use	Fixed-dose convenience but longer than some alternatives
Rifampin alone	Four months	Strong substitute; avoids isoniazid exposure
Isoniazid plus rifapentine	Three months, weekly	Competes on shorter duration and completion
Isoniazid plus rifampin	Three months	Competes directly with the same active ingredients
Isoniazid alone	Six or nine months	Older, longer-duration option

RIFAMATE has a practical advantage when clinicians want rifampin and isoniazid in one capsule. Its disadvantages are the same as the component drugs’ disadvantages: rifampin drug interactions and isoniazid-associated liver toxicity. The product also has less flexibility than prescribing the two ingredients separately, where doses can be adjusted independently.

What formulations are protected by RIFAMATE?

RIFAMATE is a hard-gelatin oral capsule containing a fixed ratio of rifampin and isoniazid. There is no evidence that the product has a current proprietary extended-release, injectable, transdermal, inhaled, or device-assisted formulation.

Its formulation value is functional:

• Reduced pill burden.
• Simplified prescribing.
• Fixed dosing for a defined patient population.
• Potentially improved adherence compared with separate capsules and tablets.

Those benefits do not create a strong patent moat. A competitor can reproduce the same active ingredients and dosage form if it satisfies FDA quality, bioequivalence, stability, and manufacturing requirements.

What patent litigation affects RIFAMATE?

No material ongoing patent litigation involving RIFAMATE is identified as a current driver of market value. The product’s litigation risk is low because:

• The core patents are expired.
• The product has no apparent high-value current formulation patent.
• Generic competition is established or technically feasible.
• The commercial value is too limited to support extensive branded patent litigation.

Potential legal exposure is more likely to involve product liability, manufacturing quality, labeling, supply contracts, or procurement disputes than Hatch-Waxman patent litigation.

Are biosimilars a risk to RIFAMATE?

No. Biosimilar competition is not relevant because RIFAMATE is a small-molecule oral capsule, not a biologic. Its relevant competitors are generic drugs and therapeutically substitutable tuberculosis regimens.

The applicable competitive pathway is conventional small-molecule generic approval, not the Biologics Price Competition and Innovation Act pathway.

What is the financial trajectory for RIFAMATE?

RIFAMATE’s financial trajectory is likely flat to declining in nominal commercial importance. Sanofi does not report RIFAMATE as a separately disclosed revenue line in its public financial statements. The product is included, if at all, within broader pharmaceutical or established-products reporting categories. [3]

The principal financial factors are:

Driver	Direction
Patent expiration	Negative
Generic competition	Negative
Shift to shorter latent-TB regimens	Negative
Public-health demand	Supports baseline volume
Global TB burden	Supports long-term need
Branded price power	Weak
Product differentiation	Modest
Supply shortages	Can create temporary upside
Commercial investment	Likely limited

Global tuberculosis incidence creates continuing medical demand. WHO reported an estimated 10.6 million people developed TB in 2022, with 1.3 million deaths among HIV-negative people and an additional 167,000 deaths among people living with HIV. [4] That epidemiologic burden supports ongoing use of rifampin and isoniazid, but it does not translate directly into high RIFAMATE revenue. Much of the market is purchased through government programs, donor-funded mechanisms, or hospital tenders at low prices.

RIFAMATE’s value is therefore more defensive than growth-oriented. It can retain a niche where prescribers value a fixed-dose product, but its revenue ceiling is constrained by low unit pricing, generic substitution, and regimen modernization.

What licensing deals involve RIFAMATE?

No major current licensing transaction centered on RIFAMATE is publicly identified. The product’s age, generic competition, and limited standalone revenue make it unlikely to support a significant asset-level licensing market.

Licensing or supply arrangements could still occur at the portfolio level, particularly involving:

• Established anti-infective brands.
• Regional commercialization rights.
• Government procurement.
• Contract manufacturing.
• Authorized generic distribution.

Those arrangements would likely be negotiated around a broader Sanofi or anti-infective portfolio rather than RIFAMATE alone.

What geographic markets matter for RIFAMATE?

RIFAMATE’s commercial relevance is greatest where:

1. Latent-TB screening and treatment are routine.
2. Fixed-dose combinations are included in procurement formularies.
3. Branded or authorized-generic supply is available.
4. Clinicians use rifampin-plus-isoniazid regimens despite competing shorter options.

The U.S. market is regulated by FDA and shaped by CDC recommendations, state TB programs, hospital formularies, and public purchasing. International markets are more fragmented. WHO guidance, national TB programs, tender pricing, local registration, and donor procurement have greater influence than brand recognition. [5]

In many high-burden markets, the relevant product is a generic fixed-dose combination supplied through public-health channels. That reduces the value of the RIFAMATE brand name.

What manufacturing and intellectual-property barriers exist?

The manufacturing barrier is moderate, not high. Rifampin can present stability, formulation, and quality-control challenges, and combination products require control of content uniformity, dissolution, impurity profiles, and capsule stability. These requirements can restrict the number of reliable suppliers.

They do not create a durable monopoly. Competitors with qualified facilities, validated processes, stable active pharmaceutical ingredient supply, and regulatory approvals can enter the market.

Supply-chain risks include:

• Rifampin API availability.
• Batch failures or recalls.
• Limited qualified manufacturers.
• Government tender concentration.
• Transportation and storage requirements.
• Demand spikes linked to TB-control campaigns.

These risks may produce temporary price or volume changes, but they are insufficient to support a sustained branded premium without supply scarcity.

What generic launch scenarios could affect RIFAMATE?

The most likely commercial path is gradual erosion rather than a single disruptive launch.

Base case

RIFAMATE remains available as a niche fixed-dose product, with low or declining revenue and limited promotional spending. Separate generic components and alternative regimens absorb most new demand.

Downside case

A lower-priced fixed-dose competitor, procurement substitution, or expanded use of four-month rifampin reduces branded volume materially. Sanofi or its commercial partner may rationalize distribution.

Temporary upside case

A shortage of generic rifampin, isoniazid, or competing fixed-dose products creates short-lived demand for RIFAMATE. The effect would depend on inventory and manufacturing capacity and would not change the long-term competitive structure.

Key Takeaways

• RIFAMATE is an established rifampin/isoniazid fixed-dose capsule for latent tuberculosis infection.
• Its FDA exclusivity and underlying patent protection expired long ago.
• No material unexpired Orange Book patent or current Paragraph IV campaign is identified.
• Generic and therapeutic substitution risk is high.
• Shorter rifamycin-based regimens are the main structural threat.
• Biosimilar competition does not apply.
• Sanofi does not separately disclose RIFAMATE revenue.
• The product’s financial trajectory is likely flat to declining, with demand sustained mainly by public-health programs and clinical niche use.
• Manufacturing quality and supply reliability matter more than intellectual-property exclusivity.
• Licensing value is limited unless bundled with a broader anti-infective portfolio.

FAQs

Is RIFAMATE still commercially available in the United States?

RIFAMATE has historically been marketed in the United States, but availability can vary by distributor, pharmacy, and procurement channel. The commercial market is supported by generic alternatives and separate rifampin and isoniazid products.

Is RIFAMATE interchangeable with rifampin alone?

No. RIFAMATE contains both rifampin and isoniazid. Rifampin monotherapy is a separate latent-TB regimen with different contraindications, interactions, monitoring requirements, and prescribing considerations.

Does RIFAMATE have a market exclusivity expiration date?

No current exclusivity expiration event is commercially relevant. The product is already well beyond its original patent and regulatory exclusivity periods.

Can RIFAMATE be used to treat active tuberculosis?

The fixed-dose product should not be treated as a complete active-TB regimen. Active disease generally requires multiple drugs selected according to susceptibility, disease site, treatment history, and current clinical guidelines.

Why would a health system buy RIFAMATE instead of generic components?

A health system may select RIFAMATE to reduce pill burden, simplify dispensing, support adherence, or standardize a defined latent-TB regimen. Price, supply reliability, dose flexibility, and local formulary policy can favor separate generic products.

References

1. U.S. Food and Drug Administration. (2018). RIFAMATE: Rifampin and isoniazid capsule prescribing information. Sanofi-Aventis U.S. LLC.

2. Sterling, T. R., Njie, G., Zenner, D., Cohn, D. L., Reves, R., Ahmed, A., Menzies, D., Horsburgh, C. R., Crane, C. M., Burgos, M., LoBue, P., Winston, C. A., & Belknap, R. (2020). Guidelines for the treatment of latent tuberculosis infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020. MMWR Recommendations and Reports, 69(1), 1-11.

3. Sanofi. (2024). Universal registration document and annual financial report 2023. Sanofi.

4. World Health Organization. (2023). Global tuberculosis report 2023. WHO.

5. World Health Organization. (2022). WHO consolidated guidelines on tuberculosis: Module 5, management of tuberculosis in children and adolescents. WHO.