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, Larken Labs Inc, Novitium Pharma, Pangea, 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-four 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:	44
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	3,474
Patent Applications:	7,694
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
Albert Einstein College of Medicine	Phase 1
Columbia University	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1

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
Hikma	DEXAMETHASONE	dexamethasone	TABLET;ORAL	084612-006	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Corepharma	DEXAMETHASONE	dexamethasone	TABLET;ORAL	218372-001	Sep 17, 2024	AB	RX	No	No
Alvogen	DEXAMETHASONE	dexamethasone	TABLET;ORAL	088481-003	Apr 28, 1983	BP	RX	No	No
Novitium Pharma	DEXAMETHASONE	dexamethasone	TABLET;ORAL	215604-003	Aug 8, 2022	AB	RX	No	No
Merck	DECADRON	dexamethasone	TABLET;ORAL	011664-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	AB	RX	Yes	Yes
Aspen Global Inc	HEXADROL	dexamethasone sodium phosphate	INJECTABLE;INJECTION	014694-002	Approved Prior to Jan 1, 1982		DISCN	Yes	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
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009

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/001140 Ozurdex 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/004071 Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for dexamethasone

Country	Patent Number	Title	Estimated Expiration
Australia	2014268434	Use of sustained release dexamethasone in post-cataract surgery inflammation
Portugal	2701773
Poland	2701773
Japan	5684239
Australia	2016201869	Biomaterials for track and puncture closure
New Zealand	616872	Dose guides for injection syringe
China	105407896	Use of sustained release dexamethasone in post-cataract surgery inflammation

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

Introduction to Dexamethasone

Dexamethasone is a potent anti-inflammatory synthetic adrenal corticosteroid used to treat a wide range of inflammatory and immune-related conditions. Its applications include allergic disorders, skin diseases, adrenal problems, arthritis, severe allergies, asthma, blood or bone marrow problems, and more recently, as a lifesaving treatment for critically ill COVID-19 patients[1][4][5].

Market Size and Forecast

The global dexamethasone market is expected to experience significant growth over the forecast period of 2021 to 2028. According to market analyses, the dexamethasone market is projected to reach USD 4,634.01 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 6.65% during this period[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the dexamethasone market:

COVID-19 Impact

The rapid adoption of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients has been a major driver. Studies, such as the RECOVERY trial, have shown that dexamethasone reduces 28-day mortality among patients receiving invasive mechanical ventilation or oxygen[5].

Increasing Prevalence of Inflammatory Conditions

The rising incidence of various inflammatory ailments, including cancer, allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, and psoriasis, is fueling the market growth[4].

Robust Investment in Research and Development

Significant investments in research and development are contributing to the market's expansion. This includes the development of new formulations and applications, such as the recent FDA approval for ciprofloxacin and dexamethasone otic suspension[1][3].

Public Awareness and Pandemic Impact

High incidences of viral disease outbreaks and increasing public awareness regarding the use of dexamethasone are also enhancing market growth[1][4].

Market Segmentation

The dexamethasone market is segmented based on several criteria:

Formulation Type

Dexamethasone is available in various forms, including oral tablets, oral solutions, eye drops, ear drops, injectable solutions, and intraocular solutions[2].

Patient Type

The market is segmented based on patient type, including adults and children, each with different dosage requirements and treatment plans[2].

Application

The primary applications include anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, COVID-19 treatment, and others. The COVID-19 sector is expected to be the fastest-growing segment due to its proven benefits in reducing mortality among critically ill patients[4].

End Users

The market is bifurcated into hospital pharmacies, clinics, pharmacy and drug stores, and online pharmacies. Hospitals are expected to hold the majority of the market share due to increased hospital admissions for various diseases, including COVID-19[4].

Geographical Analysis

North America

North America leads the dexamethasone market due to the rapid increase in COVID-19 cases and the high prevalence of diseases in the region[1][4].

Asia-Pacific

The Asia-Pacific region is expected to expand at a significant growth rate due to the rising prevalence of viral disease outbreaks and the strong presence of major dexamethasone manufacturers in this region[1][4].

Financial Trajectory

Cost Factors

The cost of dexamethasone can vary based on several factors, including treatment plans, insurance coverage, pharmacy choices, and the need for additional equipment like needles and syringes. Generic versions of dexamethasone are generally more affordable than brand-name alternatives like DexPak and Decadron[2].

Financial Assistance and Savings

Patients can lower the cost of dexamethasone through various means, such as getting a 90-day supply, using mail-order pharmacies, and utilizing savings programs and coupons. Organizations and websites provide resources for drug assistance programs and savings cards[2].

Revenue Streams

The approval of new dexamethasone formulations, such as the ciprofloxacin and dexamethasone otic suspension, can lead to increased revenue streams for pharmaceutical companies. While generics typically offer lower margins than branded drugs, they can achieve significant volume sales[3].

Challenges and Restraints

Side Effects

The various side effects associated with dexamethasone, such as depression, euphoria, and hypertension, are expected to impede market growth. These adverse effects can deter some patients and healthcare providers from using the drug[1][4].

Preventive Measures

The development of vaccines and other preventive measures could challenge the growth of the dexamethasone market by reducing the need for corticosteroid treatments[1].

Key Takeaways

• The global dexamethasone market is projected to grow significantly due to its use in treating COVID-19 and other inflammatory conditions.
• North America and Asia-Pacific are key regions driving market growth.
• The market is segmented based on formulation type, patient type, application, and end users.
• Financial assistance programs and generic versions can help reduce the cost of dexamethasone.
• Side effects and preventive measures are potential restraints on market growth.

FAQs

1. What are the primary applications of dexamethasone?

   • Dexamethasone is used for anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, COVID-19 treatment, and other inflammatory conditions[4].

2. How does the cost of dexamethasone vary?

   • The cost of dexamethasone can vary based on treatment plans, insurance coverage, pharmacy choices, and the need for additional equipment[2].

3. Is dexamethasone covered by Medicare?

   • Dexamethasone may be covered by Medicare, but coverage and costs depend on the specific Medicare plan[2].

4. What are the potential side effects of dexamethasone?

   • Potential side effects include depression, euphoria, hypertension, and other adverse effects[1][4].

5. How has COVID-19 impacted the dexamethasone market?

   • The COVID-19 pandemic has significantly increased the demand for dexamethasone due to its effectiveness in reducing mortality among critically ill patients[1][4][5].

Cited Sources

1. Data Bridge Market Research: Global Dexamethasone Market – Industry Trends and Forecast to 2028.
2. Medical News Today: Dexamethasone cost: Financial assistance, savings, more.
3. Stock Titan: Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension.
4. Verified Market Research: Dexamethasone Market Size, Share, Trends, Opportunities & Forecast.
5. MedRxiv: Effect of Dexamethasone in Hospitalized Patients with COVID-19.

Last updated: 2024-12-16