Triamcinolone acetonide - Generic Drug Details

What are the generic sources for triamcinolone acetonide and what is the scope of freedom to operate?

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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	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
Sun Pharma Canada	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	086275-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharma Canada	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	CREAM;TOPICAL	040038-001	Oct 26, 1994		DISCN	No	No
Pai Holdings Pharm	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	208590-001	Mar 3, 2017		DISCN	No	No
Astellas	ARISTOCORT A	triamcinolone acetonide	OINTMENT;TOPICAL	080745-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Quagen	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	LOTION;TOPICAL	213559-001	Jul 1, 2020	AT	RX	No	No
Pharmobedient	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	LOTION;TOPICAL	088450-001	Apr 1, 1985	AT	RX	No	Yes
Ivax Pharms	FLUTEX	triamcinolone acetonide	CREAM;TOPICAL	085539-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for triamcinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	7,977,045
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007	6,395,294
Chattem Sanofi	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013	6,143,329
Abbvie	AZMACORT	triamcinolone acetonide	AEROSOL, METERED;INHALATION	018117-001	Apr 23, 1982	3,897,779
Delcor Asset Corp	KENALOG-H	triamcinolone acetonide	CREAM;TOPICAL	086240-001	Approved Prior to Jan 1, 1982	4,048,310
Chattem Sanofi	NASACORT	triamcinolone acetonide	AEROSOL, METERED;NASAL	019798-001	Jul 11, 1991	4,767,612
Abbvie	AZMACORT	triamcinolone acetonide	AEROSOL, METERED;INHALATION	018117-001	Apr 23, 1982	3,927,806

International Patents for triamcinolone acetonide

Country	Patent Number	Title	Estimated Expiration
Israel	242395	מערכת ושיטות להזרקה עינית (Apparatus and methods for ocular injection)
Singapore	10201602789X	CORTICOSTEROIDS FOR THE TREATMENT OF JOINT PAIN
China	103260603
Canada	2807150
Philippines	12015500986	METHODS AND DEVICES FOR THE TREATMENT OF OCULAR DISEASES IN HUMAN SUBJECTS
Australia	2017268620
European Patent Office	2916827	PROCÉDÉS POUR LE TRAITEMENT DE MALADIES OCULAIRES CHEZ DES SUJETS HUMAINS (METHODS FOR THE TREATMENT OF OCULAR DISEASE IN HUMAN SUBJECTS)

Market Dynamics and Financial Trajectory for Triamcinolone Acetonide

Last updated: July 27, 2025

Introduction

Triamcinolone acetonide is a synthetic corticosteroid widely used for its anti-inflammatory, immunosuppressive, and antipruritic properties. It is available in various formulations, including injectable, topical, intranasal, and dental pastes, serving applications across dermatology, allergy, rheumatology, and respiratory conditions. Understanding the market dynamics and anticipated financial trajectory of triamcinolone acetonide allows pharmaceutical stakeholders to optimize investment strategies, streamline R&D, and anticipate competitive landscapes amidst evolving healthcare needs.

Market Overview

Global Manufacturing and Consumption

The global triamcinolone acetonide market has exhibited consistent growth, driven by its extensive approval for an array of indications, and the prevalence of chronic inflammatory and autoimmune conditions. North America remains the dominant market owing to high healthcare expenditure, advanced regulatory frameworks, and established pharmaceutical supply chains [1]. Europe maintains a significant share, supported by aging populations and rising dermatological concerns. The Asia-Pacific region is forecasted to register the highest compounded annual growth rate (CAGR), fueled by increasing healthcare infrastructure, rising affluence, and regulatory acceptance of corticosteroids [2].

Key Drivers

• Rising Prevalence of Autoimmune and Inflammatory Diseases: Conditions like rheumatoid arthritis, allergic rhinitis, psoriasis, and asthma drive demand for corticosteroids such as triamcinolone acetonide [3].

• Expanding Therapeutic Applications: Emerging indications, including certain ocular and dermatological therapies, augment its usage scope.

• Generic Market Penetration: Patent expirations have catalyzed the entry of generics, making the drug more accessible and affordable, thereby expanding user base [4].

• Product Development and Formulation Innovation: Advances in delivery methods, including long-acting injectables and combined formulations, enhance patient adherence and therapy efficacy.

Market Challenges

• Regulatory Scrutiny: Stringent safety and efficacy concerns, particularly regarding corticosteroids' systemic effects, may limit rapid approval of new formulations or uses [5].

• Side-Effect Profile: Potential adverse effects, such as osteoporosis, adrenal suppression, and local tissue atrophy, pose safety concerns that influence prescribing patterns.

• Market Competition: The presence of numerous corticosteroids with similar efficacy introduces competitive pricing pressures.

Financial Trajectory

Historical Performance

The triamcinolone acetonide market experienced steady growth over the past decade. Market size was estimated at approximately USD 600 million in 2020, with regional variations aligning with healthcare expenditure levels and prevalence rates [6]. The growth was fueled by increased generic competition and expanding clinical indications.

Forecasted Growth and Future Trends

Projections indicate a CAGR of approximately 4.5% to 6% over the next five years, reaching an estimated USD 850 million to USD 950 million by 2028. This forecast reflects:

• Continued Market Penetration of Generics: Price competition will sustain high-volume sales, especially in cost-sensitive markets.

• Innovation in Delivery Platforms: Sustained R&D investment targeting sustained-release formulations and combination therapies will likely enhance market share.

• Regulatory Approvals for New Indications: Additional approvals for novel therapeutic areas are expected to positively influence sales.

• Market Expansion into Emerging Economies: Rising healthcare investments in Asia and Latin America will augment demand.

Regional Investment and Revenue Opportunities

• North America: Remains the most lucrative region, accounting for approximately 40-45% of global sales due to established infrastructure and high disease prevalence.

• Europe: Contributes about 25-30%; growth driven by aging populations and increasing dermatological treatments.

• Asia-Pacific: Projects the fastest growth, with CAGR estimated at over 7%, driven by expanding pharmaceutical manufacturing capabilities and rising healthcare access [7].

• Latin America and Middle East & Africa: Show moderate growth, primarily through increased adoption of generics and local manufacturing.

Pricing and Market Share Dynamics

Generic competition has driven down prices, but premium formulations with improved delivery and reduced side effects command higher margins. Market share is concentrated among key pharmaceutical companies with diversified corticosteroid portfolios, including Pfizer, Sandoz, and Mylan.

Regulatory and Patent Landscape

While patent protections have largely expired, certain formulations or delivery methods (e.g., long-acting injectables) remain under patent protection or exclusivity agreements, enabling premium pricing strategies. Regulatory agencies' evolving frameworks for corticosteroids emphasize post-market surveillance to mitigate adverse effect risks, influencing formulation development strategies.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus should be on innovation beyond traditional formulations, including sustained-release systems and combination therapies, to differentiate offerings.

• Investors: Favor companies with a diversified corticosteroid portfolio, especially those advancing oral or injectable formulations with improved safety profiles.

• Regulatory Bodies: Prioritize balanced policies that encourage innovation while ensuring safety, which in turn fosters sustained market growth.

Key Market Opportunities

• Development of biosimilars and complex formulations with enhanced pharmacokinetics.
• Expansion into underpenetrated emerging markets.
• Investment in R&D for new therapeutic indications, especially in dermatology and allergy.

Conclusion

Triamcinolone acetonide's market is poised for steady growth across key regions, driven by demographic trends, expanding indications, and technological innovation. Its financial trajectory suggests resilience amidst competitive pressures, emphasizing opportunities in formulation enhancement, geographic expansion, and strategic collaborations.

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Key Takeaways

• The global market for triamcinolone acetonide is projected to reach nearly USD 950 million by 2028, with regional variations reflecting healthcare infrastructure and disease prevalence.

• Generic formulations dominate the landscape, exerting downward pressure on prices but enabling high-volume sales.

• Innovation in delivery systems and new indications represent critical growth avenues for pharmaceutical companies.

• Emerging markets, especially in Asia-Pacific, are key growth opportunities, driven by increasing healthcare access and local manufacturing capabilities.

• Regulatory developments focusing on safety monitoring will influence formulation strategies and market dynamics.

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FAQs

1. What are the primary therapeutic applications of triamcinolone acetonide?
Triamcinolone acetonide is mainly used for allergic rhinitis (intranasal), dermatological conditions like psoriasis and eczema (topical), localized joint injections for arthritis, and certain ocular inflammations.

2. How does patent expiration affect the market for triamcinolone acetonide?
Patent expiration has facilitated the entry of generic manufacturers, leading to price reductions, increased accessibility, and expanded market penetration globally.

3. What are the main safety concerns associated with triamcinolone acetonide?
Potential adverse effects include adrenal suppression, osteoporosis, skin atrophy, and local tissue damage, which necessitate careful patient monitoring and formulation improvements.

4. Which regions offer the most growth potential for triamcinolone acetonide?
The Asia-Pacific region is expected to demonstrate the highest growth rate, driven by rising healthcare expenditure, increasing prevalence of inflammatory diseases, and expanding manufacturing capacity.

5. How do formulation innovations impact the financial outlook?
Innovations such as sustained-release injectable forms and combination therapies enable premium pricing, improve patient adherence, and open new therapeutic niches, positively influencing revenue streams.

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References

[1] MarketsandMarkets, "Corticosteroids Market," 2022.
[2] Grand View Research, "Global Corticosteroids Market," 2021.
[3] World Health Organization, "Autoimmune Disease Prevalence," 2020.
[4] IMS Health, "Generic Drug Market Trends," 2021.
[5] U.S. FDA, "Guidance on Corticosteroid Safety Monitoring," 2022.
[6] Research and Markets, "Triamcinolone Acetonide Market Outlook," 2020.
[7] BioPharmGuy, "Region-wise Pharmaceutical Market Analysis," 2022.