Betamethasone valerate - Generic Drug Details

What are the generic sources for betamethasone valerate and what is the scope of patent protection?

Betamethasone valerate is the generic ingredient in eight branded drugs marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Norvium Bioscience, Cosette, Roaco, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Savage Labs, Schering, Actavis Mid Atlantic, Sciegen Pharms Inc, and Teva Pharms, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for betamethasone valerate. Fourteen suppliers are listed for this compound.

Summary for betamethasone valerate

US Patents:	0
Tradenames:	8
Applicants:	17
NDAs:	33
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	18
Patent Applications:	6,469
Drug Prices:	Drug price trends for betamethasone valerate
What excipients (inactive ingredients) are in betamethasone valerate?	betamethasone valerate excipients list
DailyMed Link:	betamethasone valerate at DailyMed

See drug prices for betamethasone valerate

Recent Clinical Trials for betamethasone valerate

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

Sponsor	Phase
Assiut University	Phase 1
Queen Mary Hospital, Hong Kong	Phase 3
Assiut University	Phase 4

See all betamethasone valerate clinical trials

Pharmacology for betamethasone valerate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for betamethasone valerate

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for betamethasone valerate

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

Paragraph IV (Patent) Challenges for BETAMETHASONE VALERATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUXIQ	Foam	betamethasone valerate	0.12%	020934	1	2007-08-10

US Patents and Regulatory Information for betamethasone valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roaco	BETADERM	betamethasone valerate	CREAM;TOPICAL	018839-001	Jun 30, 1983		DISCN	No	No
Sciegen Pharms Inc	BETAMETHASONE VALERATE	betamethasone valerate	LOTION;TOPICAL	070052-001	Jul 31, 1985	AB	RX	No	No
Savage Labs	BETATREX	betamethasone valerate	CREAM;TOPICAL	018862-001	Aug 31, 1983		DISCN	No	No
Actavis Mid Atlantic	BETAMETHASONE VALERATE	betamethasone valerate	OINTMENT;TOPICAL	070051-001	Oct 10, 1984	AB	RX	No	No
Taro	BETAMETHASONE VALERATE	betamethasone valerate	CREAM;TOPICAL	070062-001	May 14, 1985		DISCN	No	No

Expired US Patents for betamethasone valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	6,126,920
Norvium Bioscience	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	7,078,058

Betamethasone valerate Market Analysis and Financial Projection Experimental

Betamethasone Valerate Market Dynamics and Financial Trajectory

Market Overview

Betamethasone valerate is a potent topical corticosteroid used in the treatment of various skin conditions, including atopic dermatitis, nummular dermatitis, psoriasis, and other inflammatory skin diseases. Here’s a detailed look at the market dynamics and financial trajectory of betamethasone valerate.

Market Size and Growth

The betamethasone ointment market, which includes betamethasone valerate, is projected to experience significant growth. By 2027, the market size is estimated to reach $1.6 billion, growing at a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period 2022-2027[1].

Segmentation and Growth Rate

The betamethasone ointment market is segmented into different types, with betamethasone valerate being one of the key segments. Betamethasone valerate is expected to grow with the fastest CAGR of 5.3% during the forecast period 2022-2027. This rapid growth is attributed to its increasing application in treating atopic dermatitis, nummular dermatitis, psoriasis, and other skin ailments[1].

Regional Market Performance

Asia-Pacific Region

The Asia-Pacific region is anticipated to be the fastest-growing region for the betamethasone ointment market, including betamethasone valerate. This growth is driven by an increase in cases of asthma and other chronic diseases, which necessitate the use of betamethasone valerate[1].

North American Region

In the North American region, the injectable segment of betamethasone, which includes betamethasone dipropionate, held the largest market share in 2021. However, betamethasone valerate is also gaining traction due to its efficacy in treating various skin conditions and autoimmune diseases[1].

Market Drivers

Increasing Application in Various Ailments

The growing application of betamethasone valerate in treating rheumatic disorders, severe allergies, and autoimmune diseases like systemic lupus erythematosus is a significant driver of the market. Its versatility in reducing inflammation and overriding the immune system makes it a preferred choice for many medical conditions[1].

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as cancer, asthma, and autoimmune disorders is fueling the demand for betamethasone valerate. As these diseases become more common, the need for effective treatments like betamethasone valerate increases, driving market growth[1][3].

Financial Performance and Projections

Revenue Forecast

The betamethasone ointment market, which includes betamethasone valerate, is expected to see substantial revenue growth. By 2027, the market is projected to reach $1.6 billion, with betamethasone valerate contributing significantly to this growth due to its high CAGR of 5.3%[1].

Company Performance

Companies involved in the production and distribution of betamethasone valerate are likely to see increased revenue and market share. For instance, pharmaceutical companies like Perrigo, which have a strong presence in the extended topicals market, are expected to benefit from the growing demand for betamethasone valerate[2].

Competitive Landscape

The market for betamethasone valerate is competitive, with several key players operating globally. Companies are focusing on expanding their product portfolios and enhancing their distribution networks to capture a larger market share. The competitive landscape is further intensified by the entry of new players and the development of new formulations and delivery methods[4].

Challenges and Opportunities

Challenges

Despite the growth potential, the betamethasone valerate market faces challenges such as regulatory hurdles, side effects associated with long-term use, and competition from other topical corticosteroids. These factors can impact market growth and company performance[3].

Opportunities

The increasing demand for topical corticosteroids, especially in emerging markets, presents significant opportunities for growth. Innovations in formulation and delivery methods, as well as expanding into new geographic regions, can further drive the market forward[3][4].

Key Takeaways

• Market Growth: The betamethasone ointment market, including betamethasone valerate, is expected to reach $1.6 billion by 2027, growing at a CAGR of 4.5%.
• Segment Growth: Betamethasone valerate is projected to grow at a CAGR of 5.3% during the forecast period.
• Regional Performance: The Asia-Pacific region is expected to be the fastest-growing region.
• Market Drivers: Increasing application in various ailments and rising prevalence of chronic diseases are key drivers.
• Financial Performance: Companies involved in the production and distribution of betamethasone valerate are expected to see increased revenue.

FAQs

1. What is betamethasone valerate used for?

Betamethasone valerate is used in the treatment of various skin conditions, including atopic dermatitis, nummular dermatitis, psoriasis, and other inflammatory skin diseases.

2. What is the projected market size of the betamethasone ointment market by 2027?

The betamethasone ointment market is estimated to reach $1.6 billion by 2027.

3. What is the CAGR of the betamethasone valerate segment during the forecast period?

The betamethasone valerate segment is expected to grow at a CAGR of 5.3% during the forecast period 2022-2027.

4. Which region is expected to be the fastest-growing for the betamethasone ointment market?

The Asia-Pacific region is anticipated to be the fastest-growing region for the betamethasone ointment market.

5. What are the key drivers of the betamethasone valerate market?

The key drivers include the increasing application in various ailments and the rising prevalence of chronic diseases.

Cited Sources:

1. IndustryARC: Betamethasone Ointment Market - Forecast(2024 - 2030)
2. AnnualReports.com: Leveraging the Perrigo - Annual Reports
3. Reanin: Topical Corticosteroids Market | Growth | Share | Size | Trends and ...
4. The Insight Partners: Betamethasone Ointment Market Insights and Growth by 2031