BETAMETHASONE DIPROPIONATE - Generic Drug Details

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

Betamethasone dipropionate is the generic ingredient in thirteen branded drugs marketed by Chartwell Molecular, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Sun Pharma Canada, Schering, Organon, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tp Anda Holdings, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, Taro, and Merck Sharp Dohme, and is included in seventy-seven NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has seven patent family members in five countries.

There are thirteen drug master file entries for betamethasone dipropionate. Twenty-five suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE

International Patents:	7
US Patents:	18
Tradenames:	13
Applicants:	32
NDAs:	77
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	72
Patent Applications:	7,670
Drug Prices:	Drug price trends for BETAMETHASONE DIPROPIONATE
Drug Sales Revenues:	Drug sales revenues for BETAMETHASONE DIPROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE
What excipients (inactive ingredients) are in BETAMETHASONE DIPROPIONATE?	BETAMETHASONE DIPROPIONATE excipients list
DailyMed Link:	BETAMETHASONE DIPROPIONATE at DailyMed

See drug prices for BETAMETHASONE DIPROPIONATE

See drug sales revenues for BETAMETHASONE DIPROPIONATE

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE

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

Sponsor	Phase
Jinnah Postgraduate Medical Centre	PHASE1
Cairo University	NA
Yunus Burak Bayr	NA

See all BETAMETHASONE DIPROPIONATE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE

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 DIPROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SERNIVO	Topical Spray	betamethasone dipropionate	0.05%	208079	1	2018-02-15

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE

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	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	072276-001	Aug 24, 1988		DISCN	No	No
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987		DISCN	Yes	No
Glenmark Speclt	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	202894-001	Oct 30, 2015		DISCN	No	No
Sun Pharma Canada	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	077477-001	May 21, 2007	AB	RX	No	Yes
Savage Labs	ALPHATREX	betamethasone dipropionate	CREAM;TOPICAL	019138-001	Jun 26, 1984		DISCN	No	No
Teva	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM;TOPICAL	071476-001	Aug 10, 1987		DISCN	No	No

Expired US Patents for BETAMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988	4,775,529
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986	4,482,539
Organon	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983	4,070,462
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986	4,489,070
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987	4,489,071
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991	4,489,070

International Patents for BETAMETHASONE DIPROPIONATE

Country	Patent Number	Title	Estimated Expiration
Japan	2013503203
Japan	5833007
European Patent Office	3141246
Spain	2637447
World Intellectual Property Organization (WIPO)	2011026076
European Patent Office	2473161	COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID)

Market Dynamics and Financial Trajectory for Betamethasone Dipropionate

Last updated: January 17, 2026

Executive Summary

Betamethasone dipropionate, a potent synthetic corticosteroid, is widely used in dermatology for conditions like psoriasis, eczema, and dermatitis. Its market is shaped by clinical efficacy, regulatory approval, manufacturing capabilities, and evolving dermatological treatment protocols. The compound’s high potency, combined with increasing dermatological disorder prevalence globally, underpins a favorable market outlook. However, generic competition and regulatory shifts present challenges, influencing pricing and revenue streams. This comprehensive analysis explores market drivers, competitive landscape, regulatory environment, and financial forecasts, providing critical insights for stakeholders.

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1. Overview of Betamethasone Dipropionate

Chemical Profile and Therapeutic Use

• Chemical Name: 9-fluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carboxylate 17-propionate 21-acetate.
• Pharmacology: As a topical corticosteroid, it governs anti-inflammatory, immunosuppressive, and antipruritic actions.
• Formulations: Creams, ointments, lotions, gels.
• Indications: Psoriasis, eczema, dermatitis, allergic reactions.

Market Specifics

• Current Annual Market Size (Global): Estimated around $2.8 billion (2022).
• Major Regions:
  • North America (~40%)
  • Europe (~30%)
  • Asia-Pacific (~20%)
  • Rest of World (~10%)

Manufacturers

• Branded products primarily by brands like Diprolone, Betaderm.
• Major generics manufactured by industry giants: Mylan, Teva, Sandoz, etc.

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2. Market Drivers

Prevalence of Dermatological Conditions

Condition	Global Prevalence (millions)	Trends	Impact
Psoriasis	~125	Rising, driven by aging population	Increased demand for potent corticosteroids like betamethasone dipropionate.
Eczema	~240	Increasing in developed nations	Growing prescription volume, especially in children and adults.
Contact dermatitis	~150	Persistent, expanding awareness	Sustains long-term dermatology treatments.

Regulatory Approvals and Guidelines

• Recognized by FDA, EMA, and WHO as first-line therapy.
• Guidelines recommend corticosteroids for moderate-to-severe cases, boosting prescription rates.

Innovation and Formulation Advances

• Development of low-potency formulations for sensitive skin.
• Combination products (e.g., corticosteroid + antibiotic) expand market utility.

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3. Market Challenges and Restraints

Generic Competition and Pricing Pressure

• Significant generic availability erodes margins over patent expiry periods.
• Average price decline of 5-10% annually post-patent expiry.

Regulatory and Safety Concerns

• Long-term steroid use linked to skin atrophy and systemic absorption issues.
• Regulatory bodies impose warnings, potentially restricting usage or reimbursement.

Market Saturation and Regional Variability

• Mature markets nearing saturation.
• Underpenetrated regions face access barriers due to cost or distribution challenges.

Manufacturing and Supply Chain Constraints

• Raw material sourcing fluctuations.
• Stringent quality controls impacting costs.

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4. Competitive Landscape and Market Share

Company	Product Portfolio	Market Share (Estimate)	Key Strategies
Sanofi (Betaderm)	Betaderm (topical corticosteroid)	~25%	Brand loyalty, expanding formulations
Mylan (Generic)	Multiple corticosteroids	~20%	Price competition
Teva	Betamethasone formulations	~15%	Global distribution focus
Sandoz	Generics and biosimilars	~10%	Cost leadership, regional expansion
Others	Various regional players	~30%	Niche markets, localized formulations

Market Share Dynamics

• Majority driven by generics in mature markets.
• Branded products maintain premium positioning via clinical assurances.

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5. Regulatory Policies Influencing Market Trajectory

FDA and EMA Stances

• Emphasis on safety, prompting label updates and usage guidelines.
• Mandatory post-market surveillance for adverse events.

Intellectual Property Trends

• Patent expirations typically occur 10-15 years after filing.
• Patent litigations and challenges influence market entry timelines.

Reimbursement and Access Policies

• Reimbursement varies globally.
• Price controls and formulary restrictions impact sales, especially in public healthcare systems.

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6. Financial Trajectory and Forecasts

Historical Sales Data (2017–2022)

Year	Global Sales (USD millions)	CAGR	Key Factors
2017	2,400	-	Strong prescription base, limited generics
2018	2,600	8.3%	New formulation approvals, increased prevalence
2019	2,700	3.8%	Regulatory stability
2020	2,850	5.6%	COVID-19 impact on dermatology treatments
2021	2,750	-3.5%	Market saturation, supply chain issues
2022	2,800	1.8%	Recovery, generic penetration

Forecasted Growth (2023–2028)

Year	Estimated Global Sales (USD millions)	CAGR	Assumptions
2023	3,000	7.1%	Increased demand in Asia-Pacific, new formulation launches
2024	3,220	7.3%	Expanded indications, favorable regulatory environment
2025	3,470	7.7%	Evolution of biosimilars, market entry strategies
2026	3,740	8.0%	Greater access in emerging markets
2027	4,040	8.0%	Sustained growth driven by dermatological disorders
2028	4,360	8.0%	Market maturation, ongoing innovation

Drivers of Growth

• Demographic Shifts: Aging population increases dermatological needs.
• Market Penetration: Expansion into Asia-Pacific and Latin America.
• Product Innovation: New formulations, combination therapies.
• Regulatory Favorability: Streamlined approval pathways for new uses.

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7. Comparative Market Analysis

Compound	Market Size (2022, USD millions)	Main Use	Patent Status	Key Competitors
Betamethasone Dipropionate	2,800	Topical dermatology	Patent expired (major markets)	Sandoz, Teva, Mylan, Sanofi
Clobetasol Propionate	2,200	Ultra-potent corticosteroid	Patent expiration underway	Similar generics, brand players
Hydrocortisone	1,500	Mild dermatitis	Patent status varies	Multiple generic manufacturers
Desonide	800	Mild to moderate eczema	Patent expiration near	Market competition high

8. Strategic Opportunities and Risks

Opportunities

• Expansion into developing markets.
• Combining betamethasone dipropionate with newer drugs.
• Developing long-acting formulations reducing dosing frequency.
• Investing in biosimilar development for sustainable growth.

Risks

• Regulatory restrictions due to safety concerns.
• Price competition from generics.
• Market saturation in mature regions.
• Supply chain disruptions impacting manufacturing.

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Conclusion and Key Takeaways

• Market Growth is Robust: Spurred by rising dermatological disorders, especially in aging populations and emerging markets.
• Generics Dominate: Patent expirations fuel price erosion, but brand loyalty sustains certain premium segments.
• Regulatory Environment is Pivotal: Safety warnings and policy shifts influence prescribing patterns.
• Innovation Drives Future Growth: Formulation advances, combination products, and biosimilars will shape the competitive landscape.
• Financial Outlook is Positive: CAGR projections of approximately 7-8% through 2028 highlight sustained demand.

Stakeholders should focus on regional expansion, product innovation, and navigating regulatory landscapes to capitalize on the lucrative dermatology corticosteroid market.

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FAQs

Q1: What factors most significantly influence the market share of betamethasone dipropionate?
A1: Prevalence of dermatological conditions, patent expiry timings, product efficacy, safety profiles, and regulatory approvals primarily determine market share.

Q2: How does the regulatory environment impact the financial trajectory?
A2: Regulatory restrictions or sanctions can slow sales, while streamlined approval processes and positive safety assessments promote growth.

Q3: What are the primary regions for future market expansion?
A3: Asia-Pacific and Latin America show high growth potential due to increasing dermatological treatment adoption and expanding healthcare infrastructure.

Q4: How will generic competition influence pricing strategies?
A4: Increased generic presence leads to price reductions of 5-10% annually, pressuring profit margins but expanding access.

Q5: Which innovations are expected to drive future demand?
A5: Long-acting formulations, combination therapies, and biosimilars are expected to stimulate sales and address unmet clinical needs.

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References

1. Global Dermatology Market Report (2022). MarketsandMarkets.
2. FDA Drug Approvals Database (2022). U.S. Food and Drug Administration.
3. World Health Organization Dermatology Data (2021). WHO Publications.
4. Patent Status and Market Data (2022). Pharma Intelligence.
5. Regulatory Updates for Topical Corticosteroids (2021). EMA Publications.

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This analysis provides stakeholders with comprehensive insights into the current landscape and future outlook of betamethasone dipropionate, supporting strategic decision-making.