Triamcinolone acetonide - Generic Drug Details

What are the generic sources for triamcinolone acetonide and what is the scope of patent protection?

Triamcinolone acetonide is the generic ingredient in twenty-seven branded drugs marketed by Abbvie, Chattem Sanofi, Astellas, Ivax Pharms, Delcor Asset Corp, Teva, Solvay, Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Chartwell Rx, Cosette, Encube, Fougera Pharms, Glenmark Pharms Ltd, Macleods Pharms Ltd, Micro Labs, Morton Grove, Norvium Bioscience, Padagis Us, Pharmaderm, Pharmafair, Strides Pharma, Sun Pharma Canada, Taro, Topiderm, Crown Labs, Savage Labs, Pacira Pharms Inc, Apothecon, Alembic, Amneal, Dr Reddys, Eugia Pharma, Hikma, Long Grove Pharms, Mylan Labs Ltd, Parnell, Sandoz, Teva Pharms Usa, Watson Labs, Allergan, Harrow Eye, Beach Prods, Epic Pharma Llc, Pai Holdings Pharm, Pharmobedient, Quagen, Aurobindo Pharma Ltd, Extrovis, Glenmark Speclt, Padagis Israel, Senores Pharms, Cmp Pharma Inc, Rising, Sciegen Pharms Inc, Lupin Atlantis, Sanofi Aventis Us, Apotex, Perrigo Pharma Intl, Sun Pharm Inds Inc, and Bausch And Lomb Inc, and is included in one hundred and forty-three NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Triamcinolone acetonide has one hundred and sixty-five patent family members in twenty-nine countries.

There are twenty-six drug master file entries for triamcinolone acetonide. Seventy-eight suppliers are listed for this compound.

Summary for triamcinolone acetonide

International Patents:	165
US Patents:	8
Tradenames:	27
Applicants:	63
NDAs:	143
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	78
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	303
Patent Applications:	7,433
Drug Prices:	Drug price trends for triamcinolone acetonide
Drug Sales Revenues:	Drug sales revenues for triamcinolone acetonide
What excipients (inactive ingredients) are in triamcinolone acetonide?	triamcinolone acetonide excipients list
DailyMed Link:	triamcinolone acetonide at DailyMed

See drug prices for triamcinolone acetonide

See drug sales revenues for triamcinolone acetonide

Recent Clinical Trials for triamcinolone acetonide

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

Sponsor	Phase
Ain Shams University	PHASE4
King Edward Medical University	NA
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	PHASE3

See all triamcinolone acetonide clinical trials

Pharmacology for triamcinolone acetonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for triamcinolone acetonide

Anti-Inflammatory Agents

Glucocorticoids

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for triamcinolone acetonide

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for triamcinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	083017-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan	TRIVARIS	triamcinolone acetonide	INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	022220-001	Jun 16, 2008		DISCN	Yes	No
Fougera Pharms	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	085692-003	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Strides Pharma	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	210346-001	Feb 11, 2019	AT	RX	No	No

Expired US Patents for triamcinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	AZMACORT	triamcinolone acetonide	AEROSOL, METERED;INHALATION	018117-001	Apr 23, 1982	3,897,779
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	7,977,045
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	5,976,573
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007	6,395,294

International Patents for triamcinolone acetonide

Country	Patent Number	Title	Estimated Expiration
Taiwan	202103707	Injectable triamcinolone formulations
New Zealand	701069
Japan	7082599
Taiwan	200940071

Market Dynamics and Financial Trajectory for Triamcinolone Acetonide

Last updated: December 25, 2025

Executive Summary

Triamcinolone acetonide, a synthetic corticosteroid, is widely used across dermatology, allergies, rheumatology, and respiratory diseases, primarily for its anti-inflammatory and immunosuppressive properties. The drug’s market landscape exhibits robust growth driven by expanding indications, rising prevalence of autoimmune and allergic conditions, and technological advancements in drug formulation. However, patent expirations, generic competition, and regulatory fluctuations pose challenges to revenue streams. This report analyzes the current market environment, future growth prospects, competitive factors, and potential revenue trajectories for triamcinolone acetonide.

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What Are the Key Market Drivers for Triamcinolone Acetonide?

1. Rising Prevalence of Chronic Inflammatory and Autoimmune Diseases

• Conditions such as asthma, allergic rhinitis, psoriasis, and rheumatoid arthritis are increasing globally, fueling demand for corticosteroid therapies [1].
• Global autoimmune disease prevalence is projected to reach over 3.9% of the population, growing at a CAGR of 3%, directly impacting corticosteroid usage [2].

2. Expanding Indications and Formulation Innovations

• New formulations (e.g., topical creams, injections, nasal sprays) enhance drug versatility.
• Development of sustained-release injections and combination therapies enhances therapeutic outcomes.

3. Increasing Healthcare Expenditure and Access in Emerging Markets

• Rising healthcare penetration in Asia-Pacific and Latin America amplifies market reach.
• Governments investing in better allergy and autoimmune disease management drives demand.

4. Regulatory Approvals and Reimbursement Policies

• Favorable policies and approvals in key markets (FDA, EMA, PMDA) foster market growth.
• Insurance coverage and reimbursement schemes support better patient access.

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What Are the Main Challenges and Constraints?

1. Patent Expirations and Generic Competition

• Several formulations of triamcinolone acetonide are nearing patent expiry (e.g., Kenalog in the US expired in 2018).
• The influx of generics significantly reduces prices and revenue margins.

2. Regulatory and Safety Concerns

• Adverse event profiles, especially with systemic and high-dose treatments, prompt regulatory scrutiny.
• Strict regulations in certain markets limit off-label or new indications.

3. Pain Points in Market Penetration

• Competition from other corticosteroids (e.g., betamethasone, dexamethasone).
• Limited awareness or accessibility in underdeveloped regions.

4. Pricing Pressures and Reimbursement Challenges

• Cost-containment policies in public health systems constrain premium pricing strategies.

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What Is the Current Market Size and Future Forecast?

Parameter	2022 Figure	Future Projection (2028)	CAGR (2023-2028)
Global Market Value	$800 million	$1.2 billion	7.2%
Leading Regions	North America (50%), Europe (25%), Asia-Pacific (15%), others (10%)	Same distribution with growth in Asia-Pacific	—
Key Formulations	Injectable (Kenalog), topical creams, nasal sprays	Injectable expected to hold largest share	—

Note: The compound annual growth rate (CAGR) of 7.2% is driven by increasing adoption in emerging markets and expanding indications.

Regional Market Breakdown (2023–2028)

Region	Current Market Share	Expected CAGR	Key Drivers	Market Growth (USD)
North America	50%	5.8%	High prevalence, developed healthcare	$600M → $800M
Europe	25%	6.4%	Aging populations, regulatory approval	$200M → $270M
Asia-Pacific	15%	10.1%	Healthcare investment, infectious diseases	$120M → $210M
Rest of the World	10%	8.2%	Growing awareness	$80M → $130M

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How Are Innovations Shaping the Market?

Novel Formulations and Delivery Mechanisms

• Nanoemulsions and liposomal formulations improve bioavailability and reduce dosing frequency.
• Intralesional and sustained-release injections optimize local therapy.

Combination Therapies

• Integration with biologics or immunomodulators enhances treatment efficacy.

Digital and Monitoring Technologies

• Telemedicine and mobile health apps improve adherence and monitoring, indirectly boosting drug consumption.

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Competitive Landscape: Who Are the Major Players?

Company	Key Products	Market Share	Recent Developments	Geography Focus
Boehringer Ingelheim	Triamcinolone acetonide (various formulations)	~35%	Launching new topical formulations	Global, with focus in US and EU
Perrigo	Generic triamcinolone acetonide	~15%	Expanding regional presence	US, Europe, India
Mylan (Now part of Viatris)	Generic formulations	~20%	Cost-containment strategies	Global
Teva	Injectable and topical	~10%	Patent challenges and biosimilar R&D	North America, Europe

Financial Trajectory: Revenue and Profitability Outlook

Revenue Projections (2023–2028)

Year	Estimated Global Revenue (USD)	Key Drivers	Notes
2023	$800 million	Stable demand, patent expirations ongoing	Transition phase
2024	$860 million	Increased generic uptake, new formulations	Slight growth
2025	$940 million	Growing markets, expanded indications	Accelerating growth
2026	$1.05 billion	Surge in Asian markets	Market maturation
2027	$1.15 billion	Technological advances	Continued innovation
2028	$1.2 billion	Mature market consolidation	Steady growth

Profitability Trends

• Gross margins expected to decline from ~60% (pre-patent expiry) to ~45–50% due to increased generic competition.
• R&D investments in new formulations and indications are critical to sustain margins.

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How Do Regulatory Policies Impact Market and Financial Outlook?

Regulatory Expectations

• FDA and EMA require extensive safety data**, especially concerning systemic side effects.
• Post-marketing surveillance influences continued approvals and formulations.

Patent and Market Exclusivity

• Patent expirations (e.g., US patent for Kenalog expired in 2018) open markets for generics.
• New formulations and delivery methods may receive new exclusivities.

Reimbursement and Pricing Policies

• Government-mandated price caps (e.g., in the UK via NHS) apply pressure on revenue.
• Policies favoring biosimilars and generics promote affordability but reduce profit margins.

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Comparison with Other Corticosteroids

Drug	Indications	Market Size	Patent/Generic Status	Major Advantages	Limitations
Triamcinolone acetonide	Dermatology, allergy, joint injections	$800M (2022)	Multiple generics	Established efficacy	Patent expiry leading to generic erosion
Dexamethasone	Respiratory, systemic inflammatory	~$1.2B	Patents expired	Wide spectrum	Greater systemic side effects
Betamethasone	Anti-inflammatory, dermatology	~$900M	Patent held in some indications	Potent	Side effect profile

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Key Questions Addressed

• What are the primary revenue sources and growth prospects?
  Injunctions on injectable triamcinolone acetonide formulations and expanding dermatology use fuel revenue, with an impressive CAGR of approximately 7.2% until 2028.

• What factors influence pricing and profitability?
  Patent expirations, generic competition, regulatory fluctuations, and reimbursement policies primarily impact revenues and margins.

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Key Takeaways

• The global market for triamcinolone acetonide is poised for steady growth, driven by expanding indications, technological innovations, and emerging markets.
• Patent expirations have shifted revenue dynamics, emphasizing the importance of product innovation and formulation differentiation.
• Competition from generics will impose pricing pressures but also opens opportunities for new formulations and combination therapies.
• Regulatory landscapes and reimbursement policies remain critical determinants for market access and profitability.
• Companies investing in advanced drug delivery systems and emerging indications will secure competitive advantages and revenue streams.

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Frequently Asked Questions

1. How will patent expirations impact the future market for triamcinolone acetonide?

Patent expirations are likely to lead to a surge in generic entries, reducing prices and profit margins. Companies must innovate with new formulations or indications to sustain revenue growth.

2. What are the emerging therapeutic applications of triamcinolone acetonide?

Beyond traditional uses, research explores its efficacy in localized autoimmune conditions, ophthalmology, and as adjunct therapy in oncology.

3. Which regions represent the most significant growth opportunities?

Asia-Pacific and Latin America demonstrate the highest growth potential due to increasing healthcare access, prevalence of chronic inflammatory diseases, and supportive policies.

4. How do regulatory policies influence the drug's market dynamics?

Regulatory agencies increasingly scrutinize safety profiles, impacting approval timelines and post-market surveillance obligations, which can affect market entry and revenue.

5. What are the key competitive strategies for market players?

Innovating with new delivery methods, expanding indications, forming strategic alliances, and engaging in cost-effective manufacturing are critical to staying competitive.

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References

[1] Global Burden of Disease Study, 2021.
[2] Autoimmune Disease Prevalence, WHO, 2022.
[3] Market Research Future, 2023.
[4] U.S. FDA Drug Database, 2022.
[5] European Medicines Agency, 2023.