Phenylbutazone - Generic Drug Details

What are the generic drug sources for phenylbutazone and what is the scope of freedom to operate?

Phenylbutazone is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Novartis, Chartwell Rx, Ivax Pharms, Sun Pharm Industries, Watson Labs, and Fosun Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for phenylbutazone.

Summary for phenylbutazone

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	11
Drug Master File Entries:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	6,731
DailyMed Link:	phenylbutazone at DailyMed

Recent Clinical Trials for phenylbutazone

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

Sponsor	Phase
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	PHASE2
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all phenylbutazone clinical trials

Medical Subject Heading (MeSH) Categories for phenylbutazone

Anti-Inflammatory Agents, Non-Steroidal

Anatomical Therapeutic Chemical (ATC) Classes for phenylbutazone

M01AA	Butylpyrazolidines
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for phenylbutazone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	BUTAZOLIDIN	phenylbutazone	TABLET;ORAL	008319-008	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	AZOLID	phenylbutazone	CAPSULE;ORAL	087260-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fosun Pharma	PHENYLBUTAZONE	phenylbutazone	TABLET;ORAL	084339-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Phenylbutazone Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Phenylbutazone?

Phenylbutazone, an NSAID historically used for anti-inflammatory and analgesic purposes, primarily targets conditions like arthritis and gout. Despite its declining use due to safety concerns, its market presence persists in specific regions and applications.

Market Size and Trends

• The global NSAID market, including phenylbutazone, was valued at approximately $14 billion in 2022. Phenylbutazone's specific contribution is marginal due to its limited approval status.
• The drug's market has contracted significantly over the past decades, mainly due to adverse effects such as agranulocytosis and aplastic anemia.
• Current usage is concentrated in developing countries, where regulatory restrictions are less stringent, and it is administered mainly for veterinary purposes.

Regulatory Environment

• In the United States, phenylbutazone is classified as a Schedule III controlled substance, limiting human use due to safety risks.
• In Europe and North America, it is largely banned or restricted for human use; however, it remains available in some countries for veterinary medicine.

Competitive Landscape

• Alternatives such as phenemetic acid derivatives, COX-2 inhibitors, and other NSAIDs have supplanted phenylbutazone.
• The market is marked by a shift towards drugs with improved safety profiles, reducing phenylbutazone’s relevance.

Supply Chain and Distribution

• Mainly sourced from regional generic manufacturers.
• Veterinary formulations are available globally, with increasing regulation.

What Is the Financial Trajectory for Phenylbutazone?

Revenue Trends

Year	Estimated Revenue (USD millions)	Notes
2018	15	Primarily veterinary sales
2020	12	Slight decline due to increased regulation
2022	10	Further decline, with market exit in several regions

• Revenue from phenylbutazone is in steady decrease, with no major pharmaceutical company investing in new formulations.

Investment and R&D

• No significant R&D investments are reported publicly.
• Few companies pursue reformulation or improved safety profiles due to high regulatory hurdles and declining demand.

Profit Margins

• Margins are narrow owing to low-cost generics and reduced demand.
• Veterinary formulations generate modest profits; human use remains negligible.

Potential Market Revival Factors

• Rare in pipeline for new indications.
• Possible niche resurgence in veterinary or regional markets with relaxed regulation.
• No evidence suggests imminent growth or major repositioning.

How Do Regulatory and Safety Concerns Affect Market and Financial Outlook?

• Safety issues have limited phenylbutazone to niche applications.
• Regulatory agencies (FDA, EMA) restrict human use, constraining market expansion.
• Countries with lax regulations sustain some demand, but overall growth prospects remain bleak.

What Are the Future Outlooks for Phenylbutazone?

• Market will continue to contract in jurisdictions with strict regulation.
• Veterinary usage in less regulated regions may persist, but with limited impact on the global market.
• No significant development activity forecasts near-term growth or repositioning.

Key Takeaways

• Phenylbutazone's market is contracting, driven by safety concerns and regulatory restrictions.
• Revenue is declining, with minimal investment into new indications or formulations.
• The drug maintains niche use primarily in veterinary medicine in certain regions.
• Alternative NSAIDs with better safety profiles have replaced phenylbutazone in most applications.
• Future growth prospects are limited without regulatory changes or new therapeutic claims.

FAQs

1. Why has phenylbutazone fallen out of favor for human use?
   Due to severe adverse effects like blood dyscrasias, leading regulators to restrict or ban its use in many countries.

2. Is phenylbutazone still used in veterinary medicine?
   Yes, especially in regions with less regulation, for conditions like equine arthritis. However, safety concerns also restrict its use.

3. Are there any ongoing clinical trials for phenylbutazone?
   No significant clinical trials are publicly reported for new indications or formulations.

4. What alternatives have replaced phenylbutazone?
   COX-2 inhibitors (e.g., celecoxib), other NSAIDs like ibuprofen, and newer anti-inflammatory drugs.

5. Could regulatory changes revive phenylbutazone's market?
   Unlikely, unless significant safety improvements are demonstrated and regulatory policies shift dramatically.

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Sources:

[1] Grand View Research. NSAID Market Size, Share & Trends Analysis. 2022.
[2] U.S. Food and Drug Administration. Drug Safety Communications. 2019.
[3] European Medicines Agency. Market authorization updates. 2021.
[4] MarketWatch. Veterinary medicine global valuation. 2022.