Betamethasone - Generic Drug Details

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

Betamethasone is the generic ingredient in twenty-six branded drugs marketed by Schering, Merck Sharp Dohme, Am Regent, Hikma, Organon, Parke Davis, Anda Repository, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, Watson Labs, Alembic, Novast Labs, Xiromed, Norvium Bioscience, Roaco, Pharmafair, Sciegen Pharms Inc, and Teva Pharms, and is included in one hundred and twenty-two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for betamethasone.

Summary for betamethasone

US Patents:	17
Tradenames:	26
Applicants:	42
NDAs:	122
Drug Master File Entries:	66
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	200
Patent Applications:	6,594
Drug Prices:	Drug price trends for betamethasone
Drug Sales Revenues:	Drug sales revenues for betamethasone
DailyMed Link:	betamethasone at DailyMed

See drug prices for betamethasone

Recent Clinical Trials for betamethasone

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

Sponsor	Phase
Dermavant Sciences, Inc.	Phase 2/Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Phase 3

See all betamethasone clinical trials

Medical Subject Heading (MeSH) Categories for betamethasone

Anti-Asthmatic Agents

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for betamethasone

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, 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

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 betamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmaderm	BETAMETHASONE VALERATE	betamethasone valerate	LOTION;TOPICAL	018870-001	Aug 31, 1983		DISCN	No	No
Taro	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076543-001	Dec 9, 2003	AB	RX	No	No
Merck Sharp Dohme	LOTRISONE	betamethasone dipropionate; clotrimazole	LOTION;TOPICAL	020010-001	Dec 8, 2000		DISCN	Yes	No
Cosette	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	210765-001	May 11, 2020	AB	RX	No	No

Expired US Patents for betamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	CELESTONE	betamethasone	CREAM;TOPICAL	014762-001	Approved Prior to Jan 1, 1982	3,485,854
Schering	CELESTONE	betamethasone	TABLET;ORAL	012657-003	Approved Prior to Jan 1, 1982	3,485,854
Merck Sharp Dohme	CELESTONE	betamethasone	SYRUP;ORAL	014215-002	Approved Prior to Jan 1, 1982	3,485,854

Betamethasone Market Analysis and Financial Projection Experimental

Betamethasone Market Dynamics and Financial Trajectory

Introduction to Betamethasone

Betamethasone is a potent corticosteroid used in the treatment of various medical conditions, including inflammation, severe allergies, and autoimmune diseases. Its versatility in forms such as injections, ointments, and combination therapies makes it a crucial component in modern healthcare.

Market Size and Growth Projections

The global betamethasone market is poised for significant growth over the coming years. Here are some key projections:

• The betamethasone sodium phosphate market is expected to grow from USD 607.2 million in 2023 to USD 1005.67 million by 2031, with a CAGR of 6.51% during the forecast period of 2024-2031[1].
• The betamethasone ointment market is estimated to reach $1.6 billion by 2027, growing at a CAGR of 4.5% from 2022 to 2027[3].

Drivers of Market Growth

Several factors are driving the growth of the betamethasone market:

• Increasing Prevalence of Health Conditions: The rising prevalence of asthma, arthritis, and allergic disorders is a significant driver. For instance, the increasing cases of asthma in the Asia-Pacific region are fueling the demand for betamethasone dipropionate[3].
• Advancements in Pharmaceutical Manufacturing: Innovations in drug formulations, such as longer shelf life and improved efficacy, are boosting the market. Additionally, advancements in distribution channels, including the expansion of online pharmaceutical platforms, are making these medications more accessible[5].
• Research and Development: Ongoing research, such as the study by OrthoCarolina Research Institute on the use of betamethasone in treating De Quervain’s Tenosynovitis, is expected to augment demand by providing more data on the safety and efficacy of betamethasone-based medications[1].

Geographical Market Dynamics

The market for betamethasone is geographically diverse, with different regions showing varying growth patterns:

• North America: This region dominates the market due to the strong presence of leading pharmaceutical companies and significant investments in research. The high prevalence of skin ailments and rheumatic disorders in North America further supports this dominance[1][3].
• Asia-Pacific: This region is expected to have the fastest CAGR due to the increasing prevalence of conditions like asthma and cancer, which require extensive use of betamethasone[3].
• Europe and Other Regions: Europe, Middle East and Africa, and South & Central America also contribute significantly to the market, with growth driven by increasing healthcare infrastructure and awareness of combination therapies[4].

Market Segmentation

The betamethasone market is segmented based on several criteria:

• Type: Includes injections, powder injections, drops, and ointments. Each type has specific applications and growth trajectories[2].
• Application: Includes intramuscular injections, intravenous injections, and topical applications. The demand for these applications varies based on the medical condition being treated[2].

Challenges and Restraints

Despite the growth potential, the betamethasone market faces several challenges:

• Side Effects: Betamethasone can cause side effects such as soaring blood pressure, itching, muscle weakness, and osteoporosis, which can hamper market growth[3].
• Regulatory Requirements: Stringent regulatory standards, particularly in regions like North America and Europe, can slow down the approval and commercialization of new products. Compliance with these regulations adds to the financial burden on pharmaceutical companies[5].
• Competition from Alternative Treatments: The market is highly competitive, with non-corticosteroid alternatives gaining traction due to fewer side effects. This shift in preference could reduce demand for betamethasone-based treatments[5].

Investment Opportunities

The betamethasone market presents several investment opportunities:

• Research and Development: Investing in new formulations and delivery mechanisms, such as slow-release formulations and advanced topical applications, can provide significant returns. These innovations enhance therapeutic efficacy and patient compliance[5].
• Emerging Markets: Expanding healthcare services in regions like Asia-Pacific, Latin America, and Africa offers lucrative opportunities due to the high prevalence of fungal infections and other conditions treated with betamethasone[5].

Financial Trajectory

The financial trajectory of the betamethasone market is promising:

• Revenue Growth: The market is expected to see substantial revenue growth, with the betamethasone sodium phosphate market projected to reach USD 1005.67 million by 2031 and the betamethasone ointment market estimated to reach $1.6 billion by 2027[1][3].
• CAGR: The CAGR for different segments of the betamethasone market ranges from 4.5% to 6.51%, indicating a robust growth rate over the forecast period[1][3].

Key Takeaways

• The betamethasone market is driven by increasing health conditions, advancements in pharmaceutical manufacturing, and ongoing research.
• North America dominates the market, but the Asia-Pacific region is expected to grow rapidly.
• The market faces challenges such as side effects, regulatory requirements, and competition from alternative treatments.
• Investment opportunities lie in R&D and expanding into emerging markets.

FAQs

Q: What is the projected CAGR for the betamethasone sodium phosphate market from 2024 to 2031? A: The projected CAGR for the betamethasone sodium phosphate market is 6.51% from 2024 to 2031[1].

Q: Which region is expected to have the fastest CAGR for the betamethasone ointment market? A: The Asia-Pacific region is expected to have the fastest CAGR for the betamethasone ointment market[3].

Q: What are some of the side effects associated with betamethasone? A: Side effects include soaring blood pressure, itching, muscle weakness, and osteoporosis[3].

Q: How is the expansion of online pharmaceutical platforms impacting the betamethasone market? A: The expansion of online pharmaceutical platforms is making betamethasone-based medications more accessible, especially in remote areas, thus boosting market growth[5].

Q: What are the key investment opportunities in the betamethasone market? A: Key investment opportunities include research and development of new formulations and expanding into emerging markets with growing healthcare infrastructure[5].

Cited Sources

1. Markets and Data, Betamethasone Sodium Phosphate Market Size, Growth, Report 2031.
2. Market Research Intellect, Global Betamethasone Sodium Phosphate Market Size, Trends and ....
3. IndustryARC, Betamethasone Ointment Market - Forecast(2024 - 2030).
4. The Insight Partners, Betamethasone Ointment Market Insights and Growth by 2031.
5. Global Growth Insights, Clotrimazole and Betamethasone Diproprionate Market.