Sponsor	Phase
Liverpool School of Tropical Medicine	Phase 3
Rede TB	Phase 3
Institute of Tropical Medicine, Belgium	Phase 3

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	NYDRAZID	isoniazid	INJECTABLE;INJECTION	008662-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bristol Myers Squibb	NYDRAZID	isoniazid	TABLET;ORAL	008392-003	Approved Prior to Jan 1, 1982		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

Last updated: August 13, 2026

Executive summary: NYDRAZID is the former branded formulation of isoniazid, an anti-tuberculosis drug. Its branded commercial value has effectively disappeared because isoniazid has been generic for decades, its core composition patents expired long ago, and tuberculosis treatment is dominated by public-health procurement. The active ingredient remains clinically relevant, but revenue has shifted from branded pharmaceutical sales to low-margin generic tablets, oral solutions, and government tenders. No public company reports standalone NYDRAZID revenue, and no reliable basis exists for a current brand-specific valuation.

NYDRAZID Market Dynamics and Financial Trajectory

NYDRAZID is an established isoniazid product with residual clinical importance but negligible standalone brand economics. The product is associated with isoniazid, usually supplied as 50 mg, 100 mg, and 300 mg tablets and, historically, as an oral solution. Isoniazid remains used for treatment and prevention of tuberculosis, including latent tuberculosis infection, but it competes with combination regimens and shorter preventive-treatment courses.

The commercial market is therefore divided into two separate assets:

The historical NYDRAZID brand, which has little identifiable current revenue.
The generic isoniazid market, which continues to supply public-health programs, hospitals, pharmacies, and international tuberculosis initiatives.

What is NYDRAZID and who owns the product?

NYDRAZID is a historical brand name for isoniazid, also known as isonicotinic acid hydrazide. The product was commercialized as an anti-tuberculosis medicine and became part of the standard tuberculosis treatment infrastructure after isoniazid entered clinical use in the 1950s.

Historical product labeling identifies NYDRAZID as an isoniazid product associated with Roche. Current commercial control of the active ingredient is fragmented among generic manufacturers and suppliers. The original branded product is not the economic center of the market.

Product attribute	NYDRAZID position
Active ingredient	Isoniazid
Therapeutic area	Tuberculosis treatment and prevention
Historical dosage forms	Tablets and oral solution
Typical tablet strengths	50 mg, 100 mg, 300 mg
Original commercial status	Historical branded product
Current market structure	Generic and public-sector supply
Biosimilar exposure	None
Core patent status	Long expired
Standalone revenue disclosure	None identified in public company reporting

The clinical value of isoniazid remains material. The commercial value of the NYDRAZID brand does not track that clinical relevance because the product has long been exposed to generic competition.

When did NYDRAZID lose exclusivity?

NYDRAZID lost meaningful market exclusivity decades ago. Isoniazid was introduced in the 1950s, placing any original composition or basic product patents well beyond their statutory terms in the United States and other major markets.

There is no current exclusivity period comparable to a modern small-molecule launch. The relevant commercial constraints are manufacturing approval, supply reliability, procurement qualification, and regulatory compliance rather than patent protection.

Exclusivity category	Current position
Original composition patent	Expired
Original brand protection	Expired or commercially inactive
Regulatory exclusivity	No current brand-level exclusivity identified
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	Not applicable
Patent-term extension	Not commercially relevant
Data exclusivity	Expired or inapplicable
Market exclusivity for generic suppliers	None

Any current attempt to sell isoniazid in the United States must compete primarily on price, quality, supply continuity, formulation availability, and purchasing-channel access.

What patents protect NYDRAZID today?

No active patent estate is central to NYDRAZID or ordinary isoniazid tablets. The basic active-ingredient technology is public-domain technology from a patent perspective.

Are formulation patents a barrier?

Formulation patents are not a meaningful barrier for standard isoniazid tablets. A manufacturer may hold patents or other rights covering a specific excipient system, modified-release design, packaging configuration, or combination product, but those rights would not protect the historical NYDRAZID formulation as a broad commercial category.

The principal dosage forms are technically straightforward:

Immediate-release tablets
Oral solutions or syrups
Fixed-dose combinations with other tuberculosis medicines
Compounded or program-specific pediatric formulations

The most relevant technical risks are stability, dissolution, dose uniformity, impurities, packaging, and manufacturing consistency. Those are regulatory and quality barriers, not barriers created by the expired NYDRAZID brand estate.

Are method-of-use patents relevant?

Method-of-use patents are not a significant factor in the standard use of isoniazid for tuberculosis treatment or latent tuberculosis infection. Treatment protocols are governed primarily by public-health guidelines, clinical evidence, resistance patterns, and regulatory labeling.

Isoniazid monotherapy for latent tuberculosis infection has also faced commercial pressure from shorter regimens, including rifamycin-based options. The shift affects demand for isoniazid units even though it does not create a new patent threat to NYDRAZID.

What is the FDA regulatory status of NYDRAZID?

The historical NYDRAZID brand is not the basis of current U.S. market supply. Isoniazid remains an FDA-recognized active ingredient supplied through generic products and tuberculosis treatment programs.

FDA product status should be separated into three categories:

FDA issue	NYDRAZID and isoniazid position
Historical brand	No meaningful current branded market position
Generic isoniazid	Remains clinically and regulatorily relevant
Discontinued brand listing	A discontinued listing does not by itself mean withdrawal for safety or lack of efficacy
Current approval pathway	Generic products require applicable ANDA or other FDA authorization
Combination regimens	Separate products and regulatory records may apply
Drug shortage exposure	Can affect procurement and patient access even without patent barriers

FDA records for older products can identify a product as discontinued without establishing that the active ingredient is unsafe or ineffective. In the case of isoniazid, public-health authorities continue to recommend the drug in defined tuberculosis treatment and prevention regimens.[1][2]

What is the Orange Book status of NYDRAZID?

NYDRAZID has no commercially meaningful Orange Book position as an active branded reference product. The Orange Book is relevant to approved drug applications and listed patents, but it does not preserve commercial exclusivity for a historical brand once the underlying protections have expired or the branded product has left the market.

For a current generic isoniazid applicant, the main regulatory issues are approval pathway, bioequivalence where applicable, chemistry and manufacturing controls, labeling, and product availability. A Paragraph IV strategy would not ordinarily be expected to create value against an old, unprotected isoniazid brand.

Are there Paragraph IV challenges to NYDRAZID?

A commercially relevant Paragraph IV challenge to NYDRAZID is unlikely. Paragraph IV litigation is designed to challenge unexpired patents listed for an approved reference product. NYDRAZID's core commercial protections are historically expired, and the product does not present the profile of a protected modern reference drug.

Generic applicants could still face regulatory or commercial obstacles, including:

Failure to demonstrate bioequivalence
Manufacturing inspection findings
Product-quality deficiencies
Inability to secure a reliable active pharmaceutical ingredient
Procurement disqualification
State or federal contracting barriers
Competitive pricing pressure

Those obstacles do not create patent exclusivity for NYDRAZID.

Which companies are challenging NYDRAZID?

No current branded challenger is needed to displace NYDRAZID. The product has already been displaced by generic isoniazid suppliers.

The competitive set includes manufacturers of generic isoniazid tablets and oral solutions, contract manufacturers, wholesalers, government suppliers, and international tuberculosis-program vendors. Supplier participation changes by country and tender cycle. In the United States, product availability can depend on the number of active manufacturers, manufacturing-site capacity, and wholesaler inventory.

The competitive landscape is more fragmented than concentrated:

Competitive factor	Market effect
Brand competition	Minimal
Generic competition	High
Price sensitivity	High
Differentiation	Limited for standard tablets
Public procurement	Major demand channel
Retail demand	Smaller and less predictable
Supply interruptions	Can materially affect market share
Switching costs	Low for approved equivalent products

How does NYDRAZID compare with competing tuberculosis drugs?

Isoniazid remains important but is no longer the sole commercial anchor for tuberculosis treatment.

Drug or regimen	Commercial relationship to isoniazid
Rifampin	Reduces reliance on isoniazid monotherapy in some preventive-treatment settings
Rifapentine	Supports shorter preventive regimens that can reduce isoniazid duration
Rifampin plus isoniazid	Maintains isoniazid demand in combination treatment
Rifampin, isoniazid, pyrazinamide, ethambutol	Standard multidrug treatment architecture for drug-susceptible tuberculosis
Bedaquiline and newer agents	More relevant to drug-resistant tuberculosis than ordinary NYDRAZID demand
Fixed-dose combinations	Can reduce the role of individually dispensed isoniazid tablets

The principal demand risk is regimen substitution. The clinical advantage of shorter preventive courses can reduce the number of months during which patients receive isoniazid. That does not eliminate isoniazid demand because tuberculosis treatment programs still use it widely, particularly in combination therapy and in settings where cost is decisive.

What is the financial trajectory for NYDRAZID?

The financial trajectory has four stages.

1. Branded adoption

NYDRAZID initially benefited from the clinical importance of isoniazid and the need for a reliable tuberculosis medicine. During this period, the brand captured value from product recognition, formulation supply, and limited competition.

2. Patent and generic erosion

Once the basic technology entered the public domain, generic manufacturers reduced the price ceiling. The product became less suitable for premium branded pricing. Revenue would have shifted from brand margin to volume-driven sales.

3. Brand withdrawal or commercial decline

The historical NYDRAZID brand lost economic relevance as generic isoniazid became available. No public reporting provides a current standalone NYDRAZID revenue series. Roche and other large pharmaceutical companies do not report the product as a material individual contributor in current segment disclosures.

4. Generic and institutional supply

Current value is captured through low-priced generic sales and institutional contracts. Demand is tied to tuberculosis incidence, national treatment guidelines, donor funding, government budgets, and tender wins. The market has clinical demand but weak pricing power.

Financial driver	Direction
Historical brand revenue	Declined to immaterial or unreported levels
Unit demand	Remains recurring in tuberculosis programs
Unit price	Low and heavily negotiated
Gross margin	Constrained by generic competition
Brand marketing value	Minimal
Public-sector dependence	High
Revenue visibility	Low for individual suppliers
Supply-chain value	Higher than brand value

The commercial profile resembles an essential generic medicine rather than an innovator asset. A supplier can generate recurring revenue from volume and contracts, but the product is unlikely to support significant royalty income, premium pricing, or a differentiated licensing valuation.

What licensing deals affect NYDRAZID?

No major current licensing transaction is publicly associated with the historical NYDRAZID brand. Licensing economics are more likely to arise around:

Regional distribution rights
Government procurement contracts
Fixed-dose combination products
Pediatric formulations
Contract manufacturing
Active pharmaceutical ingredient supply
Tuberculosis-program financing

A license involving isoniazid would generally be evaluated on manufacturing capacity, regulatory approvals, geographic access, and tender eligibility rather than on exclusive patent rights.

What patent litigation affects NYDRAZID?

No major current patent litigation is central to NYDRAZID's commercial position. The absence of litigation is consistent with the product's age, generic status, and lack of a valuable active patent estate.

Potential disputes would more likely involve product quality, supply contracts, regulatory compliance, trademark use, or procurement decisions. Those matters can affect individual suppliers but do not restore exclusivity to the historical brand.

What generic launch risks exist for isoniazid?

Generic launch risk is operational rather than patent-based.

Manufacturing and intellectual-property barriers

The main barriers include:

Compliance with current good manufacturing practices
Control of impurities and degradation products
Reliable API sourcing
Stability across intended shelf life
Adequate dissolution and dose uniformity
Pediatric dosage-form development
FDA or other national regulatory approval
Qualification for public tenders
Ability to maintain supply during low-margin periods

Isoniazid's chemistry is mature, so technical complexity is modest compared with complex injectables or biologics. The low selling price can itself become a business risk because manufacturers may exit if production, testing, and compliance costs exceed expected returns.

Geographic coverage

Demand is concentrated in countries with significant tuberculosis burdens and in health systems with active latent-tuberculosis screening and treatment programs. The commercial opportunity differs by geography:

United States: regulated generic market with public-health and hospital demand
Europe: national procurement and established generic competition
India: major manufacturing base and high tuberculosis burden
China: large domestic treatment market and local supply
Africa: donor-supported and government-led procurement
Global tuberculosis programs: price-sensitive, qualification-driven purchasing

A supplier with approvals and tender access in multiple regions can achieve more stable volume than a company dependent on one national market.

How strong is the NYDRAZID patent estate?

The NYDRAZID patent estate is commercially weak to nonexistent. The product has no meaningful remaining protection around the basic molecule, ordinary immediate-release tablets, or established tuberculosis uses.

Patent-strength factor	Assessment
Core composition claims	Expired
Standard tablet claims	Weak or expired
Method-of-use protection	No meaningful current barrier identified
Orange Book leverage	Minimal
Paragraph IV leverage	Minimal
Biosimilar protection	Not applicable
Manufacturing know-how	Potentially useful but nonexclusive
Trademark value	Limited for current demand
Overall patent strength	Very weak

The relevant investment question is not whether NYDRAZID can defend premium pricing. It is whether a supplier can produce an essential generic drug at acceptable cost and maintain regulatory and procurement access.

Key Takeaways

NYDRAZID is a historical brand of isoniazid, not a high-value current branded pharmaceutical asset.
The active ingredient remains clinically important in tuberculosis treatment and prevention.
Original patents and brand-level exclusivity expired decades ago.
No meaningful current Orange Book, Paragraph IV, biosimilar, or patent-litigation strategy is associated with the product.
Revenue has migrated from branded sales to low-margin generic and public-sector procurement.
Shorter rifamycin-based preventive regimens create demand pressure, while multidrug tuberculosis treatment preserves isoniazid volume.
The principal risks are supply continuity, manufacturing compliance, procurement access, and price erosion.
No public company reports standalone NYDRAZID revenue, making a brand-specific financial forecast unavailable.
The product may support recurring generic volume but has limited licensing, royalty, or premium-valuation potential.

FAQs About NYDRAZID Market Value and Exclusivity

Is NYDRAZID still sold in the United States?

The historical branded product has no meaningful current U.S. commercial position. Isoniazid remains available through generic products and public-health channels.

Is NYDRAZID the same as isoniazid?

Yes. NYDRAZID is a historical brand associated with isoniazid, the active ingredient used in tuberculosis treatment and prevention.

Can a generic manufacturer launch isoniazid without a patent license?

For standard isoniazid products, expired core patent rights generally do not require a patent license. The manufacturer must still satisfy applicable regulatory, manufacturing, labeling, and procurement requirements.

Does NYDRAZID have biosimilar competition?

No. Isoniazid is a chemically synthesized small molecule, not a biologic. Generic-drug rules apply rather than biosimilar rules.

What would increase the commercial value of an isoniazid product?

Value could increase through reliable supply, pediatric formulations, fixed-dose combinations, regional regulatory approvals, government contracts, or access to underserved tuberculosis markets. Those opportunities depend on execution and procurement, not on NYDRAZID's historical brand rights.

References

Centers for Disease Control and Prevention. (2020). Latent tuberculosis infection: A guide for primary health care providers. U.S. Department of Health and Human Services.
Centers for Disease Control and Prevention. (2024). Treatment for tuberculosis disease. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (n.d.). Nydrazid (isoniazid) prescribing information and drug product records. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.
World Health Organization. (2024). Global tuberculosis report 2024. World Health Organization.

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	2
Patent Applications:	3,602
DailyMed Link:	NYDRAZID at DailyMed

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