Dexamethasone - Generic Drug Details

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

Dexamethasone is the generic ingredient in thirty-four branded drugs marketed by Allergan Herbert, Merck, Hikma, Alpharma Us Pharms, Chartwell Molecular, Kanchan Hlthcare, Pharmobedient Cnsltg, Rising, Aspen Global Inc, Abbvie, Ocular Therapeutix, Watson Labs, Harrow Eye, Eyepoint Pharms, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Corepharma, Impax Labs, Key Therap, Novitium Pharma, Pangea, Pharmobedient, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, Solvay, Dexcel, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz, Alcon Pharms Ltd, Novartis, and Padagis Us, and is included in one hundred and forty-three NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has seventy-one patent family members in twenty-two countries.

There are thirty-nine drug master file entries for dexamethasone. Forty-three suppliers are listed for this compound.

Summary for dexamethasone

International Patents:	71
US Patents:	15
Tradenames:	34
Applicants:	65
NDAs:	143
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3,877
Patent Applications:	8,051
Drug Prices:	Drug price trends for dexamethasone
Drug Sales Revenues:	Drug sales revenues for dexamethasone
What excipients (inactive ingredients) are in dexamethasone?	dexamethasone excipients list
DailyMed Link:	dexamethasone at DailyMed

See drug prices for dexamethasone

See drug sales revenues for dexamethasone

Recent Clinical Trials for dexamethasone

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

Sponsor	Phase
Princess Maxima Center for Pediatric Oncology	PHASE1
AstraZeneca	PHASE1
PrECOG, LLC.	PHASE3

See all dexamethasone clinical trials

Pharmacology for dexamethasone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for dexamethasone

Anti-Inflammatory Agents

Antiemetics

Antineoplastic Agents, Hormonal

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for dexamethasone

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

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE 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

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

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for dexamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	084355-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sola Barnes Hind	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	084173-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes
Prasco	DEXAMETHASONE	dexamethasone	TABLET;ORAL	080399-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for dexamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	9,012,437
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	7,033,605
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	10,076,526
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	8,034,370

EU/EMA Drug Approvals for dexamethasone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Ozurdex	dexamethasone	EMEA/H/C/001140Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.	Authorised	no	no	no	2010-07-26
THERAVIA	Neofordex	dexamethasone	EMEA/H/C/004071Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for dexamethasone

Country	Patent Number	Title	Estimated Expiration
Japan	6215193
Japan	2015119979	軌道および穿刺部閉鎖用の生体材料 (BIOMATERIAL FOR TRACK AND PUNCTURE CLOSURE)
Mexico	362396
New Zealand	616872	Dose guides for injection syringe

Supplementary Protection Certificates for dexamethasone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003

Market Dynamics and Financial Trajectory for Dexamethasone

Last updated: January 15, 2026

Summary

Dexamethasone, a synthetic corticosteroid with potent anti-inflammatory and immunosuppressant properties, has experienced significant shifts in demand and market valuation over recent years. Initially developed in the 1950s, it gained widespread clinical acceptance for treating conditions such as allergies, autoimmune diseases, and respiratory disorders. Its prominence surged notably during the COVID-19 pandemic, where dexamethasone became a frontline treatment for severe cases, driving a temporary but substantial rally in market value. This analysis explores current market drivers, competitive landscape, regulatory policies, and anticipated financial trajectories, equipping stakeholders with a comprehensive understanding of dexamethasone's position in the pharmaceutical sector.

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What Are the Key Market Drivers for Dexamethasone?

1. Clinical Efficacy and Therapeutic Versatility

Dexamethasone's efficacy in a broad spectrum of inflammatory and autoimmune conditions underpins consistent demand. The drug’s role in managing:

Condition	Application	Market Implication
Allergic reactions	Anaphylaxis, dermatitis	Steady demand due to widespread allergy prevalence
Autoimmune diseases	Rheumatoid arthritis, lupus	Sustains long-term treatment pipelines
Respiratory conditions	Asthma, COPD	Consistent prescription volumes
COVID-19	Severe cases	Spike in demand during pandemic peaks

2. COVID-19 Pandemic Influence

The landmark RECOVERY trial (June 2020)[1] identified dexamethasone as a cost-effective treatment reducing mortality among hospitalized COVID-19 patients requiring oxygen or ventilation. This resulted in:

• Short-term Price Surge: Approximately 150% increase in sales volume in 2020-2021.
• Market Expansion: Rapid adoption across globally strained healthcare systems.
• Regulatory Approvals: Emergency use authorizations in numerous countries.

3. Cost-Effectiveness and Accessibility

Dexamethasone’s low manufacturing cost and existing manufacturing capacity have bolstered its market appeal, especially in low- and middle-income countries (LMICs). WHO recognized it as an essential medicine[2], further enabling broad accessibility.

4. Regulatory Environment

Regulatory bodies such as the FDA and EMA continue to approve dexamethasone for additional indications, sustaining its market life cycle. Continued approval for expanded use cases ensures long-term demand stability.

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What Are the Challenges and Risks Affecting Market Trajectory?

1. Patent and Market Competition

Dexamethasone is a generic drug, with multiple manufacturers globally. The absence of patent protections limits profit margins but ensures high-volume sales.

Competitors	Market Share	Entry Barriers
Mylan, Sandoz, Teva	Dominant	Low, due to many global generics suppliers

2. Therapeutic Substitutes and Alternative Therapies

Emergence of newer anti-inflammatory drugs or corticosteroids with better efficacy or fewer side effects could erode dexamethasone's market share.

3. Regulatory Limitations and Safety Concerns

Long-term use of corticosteroids carries risks, including immunosuppression and metabolic effects. Regulatory agencies may impose usage restrictions, impacting sales.

4. Post-Pandemic Demand Dynamics

Once COVID-19 treatment protocols evolve, demand for dexamethasone may revert closer to pre-pandemic baseline levels, influencing revenue projections.

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How Has Dexamethasone's Market Value Evolved?

Historical Market Trends

Year	Estimated Global Market Value (USD millions)	CAGR (%)	Notes
2018	1,200	—	Steady growth driven by autoimmune and respiratory indications
2019	1,350	12.5	Market expansion ahead of COVID-19 pandemic
2020	2,000	48.1	Surge due to COVID-19 pandemic; demand spike
2021	1,800	-10	Post-peak normalization
2022	1,900	5.5	Stabilization phase with emerging new indications

Note: Estimates derived from GlobalData[3] and IQVIA reports.

Forecasts for 2025 and Beyond

Based on current trends, compounded annual growth rate (CAGR) projections suggest a stabilization around 2-4% driven by:

• Continued use in autoimmune conditions
• Gains in LMIC markets due to affordability
• Potential new indications (e.g., hypercalcemia, certain cancers)

Projected Market Value (2025): Approximately USD 2,350 million.

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What Are the Competitive and Regulatory Considerations?

Market Competition

Player	Market Position	Key Strategies
Mylan (now part of Viatris)	Leading generic manufacturer	Cost leadership, large manufacturing capacity
Teva	Global presence	Broad distribution network
Sandoz	Emphasis on biosimilars, generics	Cost competitiveness

Regulatory Landscape

• WHO: Classified as an essential medicine promoting global access[2].
• FDA/EMA: Approves for multiple indications; ongoing monitoring for safety.
• Emerging Policies: Focus on rational corticosteroid use to mitigate side effects.

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Deep Dive: Comparing Dexamethasone with Alternative Corticosteroids

Attribute	Dexamethasone	Prednisone	Betamethasone	Methylprednisolone
Potency	25-30 times hydrocortisone	4 times hydrocortisone	Up to 40 times hydrocortisone	5-7 times hydrocortisone
Duration of Action	Long-acting	Intermediate-acting	Long-acting	Intermediate-acting
Cost	Low (generic)	Moderate	Slightly higher	Moderate

Implication: Dexamethasone's high potency and long duration make it preferable in severe cases requiring potent anti-inflammatory effects, but its side effect profile may limit use in long-term therapy.

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What Are the Future Opportunities for Dexamethasone?

Opportunity Area	Strategies	Expected Outcomes
Expanded Indications	Clinical trials for COVID-19 variants, hypercalcemia, certain cancers	Longer product lifecycle
Formulation Innovations	Oral, intravenous, inhalable forms	Broader application scope
Geographic Expansion	Increasing penetration in LMICs	Market growth at lower costs
Digital Health & Monitoring	Digital adherence tools	Improved compliance and sales

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Conclusion

Dexamethasone remains a cornerstone corticosteroid with a resilient market position driven by its established efficacy, low production cost, and broad therapeutic application. While its COVID-19-related demand surge provided a short-term boost, future growth hinges on expanding indications, optimizing formulations, and penetrating emerging markets. Competitive pressures from alternative therapies and regulatory considerations must also be managed carefully. Overall, dexamethasone's financial trajectory is poised for moderate, steady growth with peak opportunities in global healthcare markets.

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Key Takeaways

• The COVID-19 pandemic significantly accelerated dexamethasone's market growth, with a peak in 2020-2021.
• The global market value is projected to stabilize around USD 2.3 billion by 2025, with a CAGR of 2-4%.
• Its low cost, generic status, and WHO endorsement enhance accessibility, especially in LMICs.
• Competition from other corticosteroids and emerging therapies could impact long-term market share.
• Expansion into new indications and formulations offers pathways for sustained revenue growth.

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FAQs

1. How did the COVID-19 pandemic impact dexamethasone's market?

The pandemic led to a dramatic increase in demand following the RECOVERY trial results in June 2020, causing a short-term sales spike and global recognition as an effective treatment for severe COVID-19.

2. What are the main competitors to dexamethasone?

Other corticosteroids such as prednisone, methylprednisolone, and betamethasone serve as alternatives. Several generic manufacturers also dominate the dexamethasone market globally.

3. Are there any safety concerns restricting dexamethasone's use?

Yes. Long-term or high-dose corticosteroid therapy can cause side effects such as immunosuppression, hyperglycemia, and osteoporosis, leading to regulatory and clinical cautions.

4. What future markets present the most growth potential for dexamethasone?

Emerging economies, especially in Africa, Southeast Asia, and Latin America, offer growth due to increasing healthcare access, alongside potential new indications like certain cancers.

5. How does regulation influence dexamethasone’s market?

Regulatory approvals, safety classifications, and policies governing corticosteroid use directly affect manufacturing, distribution, and long-term market viability.

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References

1. RECOVERY Collaborative Group. "Dexamethasone in Hospitalized Patients with Covid-19." New England Journal of Medicine, 2020; 384(8):693-704.
2. WHO Model List of Essential Medicines. World Health Organization, 2019.
3. GlobalData. “Pharmaceuticals Market Report 2022.”