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, Taro, 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, Trupharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, and Merck Sharp Dohme, and is included in seventy-seven NDAs. There are seventeen 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:	17
Tradenames:	13
Applicants:	31
NDAs:	77
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	66
Patent Applications:	7,738
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
Dermavant Sciences, Inc.	Phase 2/Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Oticara Australia PTY LTD	Phase 2

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
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,775,851		Y
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	AB	RX	Yes	Yes
Fougera Pharms Inc	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	019141-001	Sep 4, 1984	AB	RX	Yes	Yes
Padagis Israel	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	215847-001	Apr 12, 2022	AB	RX	No	No
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006	AB	RX	Yes	Yes
Taro	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	SPRAY;TOPICAL	211722-001	Jun 17, 2020		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	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983	4,070,462
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986	4,482,539
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991	4,489,070
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987	4,489,071
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	4,489,070

International Patents for BETAMETHASONE DIPROPIONATE

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

Market Dynamics and Financial Trajectory for Betamethasone Dipropionate

Last updated: July 5, 2025

Introduction

Betamethasone dipropionate, a potent topical corticosteroid, has long played a critical role in treating inflammatory skin conditions such as eczema, psoriasis, and dermatitis. First approved by the FDA in the 1970s, this drug exemplifies the pharmaceutical industry's balance between innovation and accessibility. As global demand for dermatological treatments rises, driven by aging populations and increasing skin disorder prevalence, understanding its market dynamics and financial path becomes essential for investors and executives navigating the competitive landscape.

This analysis delves into the current market forces shaping betamethasone dipropionate, including supply chains, regulatory hurdles, and competitive pressures. It also examines the drug's financial trajectory, from historical revenue streams to future projections, highlighting key inflection points like patent expirations and generic entries. By focusing on data-driven insights, stakeholders can make informed decisions in a sector where precision drives profitability.

Overview of Betamethasone Dipropionate

Betamethasone dipropionate belongs to the glucocorticoid class, offering anti-inflammatory and immunosuppressive effects that alleviate symptoms in various dermatological conditions. Marketed under brand names like Diprolene by Merck & Co., it generates revenue through formulations such as creams, ointments, and lotions. The drug's mechanism involves binding to glucocorticoid receptors, reducing cytokine production and easing inflammation, making it a staple in outpatient dermatology.

Historically, betamethasone dipropionate benefited from robust patent protection. The original patents, filed in the mid-20th century, expired decades ago, paving the way for generic versions. Today, major players like Teva Pharmaceutical Industries and Sandoz dominate production, with global manufacturing centered in cost-efficient regions such as India and China. Regulatory bodies, including the FDA and EMA, enforce strict quality standards, requiring bioequivalence studies for generics to ensure efficacy and safety.

Market penetration remains strong in developed economies, where prescription volumes correlate with rising healthcare spending. In emerging markets, affordability challenges persist, but growing access to healthcare infrastructure boosts adoption. This drug's trajectory underscores the pharmaceutical sector's evolution, where initial innovation yields to commoditization, influencing pricing and market share.

Current Market Dynamics

The global market for betamethasone dipropionate reached approximately $500 million in 2023, according to recent industry reports, with a compound annual growth rate (CAGR) of 4-6% projected through 2030. Key drivers include the escalating incidence of autoimmune skin disorders, fueled by environmental factors and lifestyle changes. In the U.S., for instance, eczema affects over 31 million people, sustaining demand for reliable treatments like this drug.

Competition intensifies as generic manufacturers erode brand loyalty. Teva and Mylan lead with cost-effective alternatives, capturing 60-70% of the market share in mature regions. Brand-name players counter with combination therapies, such as betamethasone paired with calcipotriene, to differentiate offerings and command premium pricing. Regulatory dynamics further shape the landscape; the FDA's expedited approval pathways for generics accelerate market entry, while post-market surveillance mandates ongoing safety data submissions.

Geographically, North America and Europe account for over 50% of sales, driven by robust reimbursement policies and high diagnosis rates. Asia-Pacific emerges as a growth hotspot, with countries like India witnessing double-digit increases due to expanding middle-class populations and improved distribution networks. Supply chain disruptions, highlighted by the COVID-19 pandemic, exposed vulnerabilities, prompting companies to diversify sourcing and invest in resilient logistics.

Emerging trends, such as digital health integration, influence dynamics. Telemedicine platforms boost prescription rates by enabling remote consultations, while sustainability initiatives push for eco-friendly packaging. Barriers include stringent regulations on steroid use, which limit over-the-counter availability and favor prescription-only models, thereby concentrating market power among established distributors.

Financial Trajectory and Projections

Financially, betamethasone dipropionate has followed a trajectory typical of mature pharmaceuticals: peak revenues post-patent, followed by declines due to generics. In the 1990s and early 2000s, Merck reported annual sales exceeding $200 million for Diprolene, capitalizing on exclusivity. By 2010, patent losses triggered a 40% revenue drop as generics flooded the market, with Teva alone generating over $100 million in related sales by 2020.

Recent financial data reveals stabilization. Global revenues stabilized at around $450-500 million in 2022-2023, per pharmaceutical analytics firms, buoyed by volume growth in emerging markets. Profit margins vary; brand manufacturers achieve 30-40% margins through premium pricing, while generics operate at 15-25% due to price erosion. For example, U.S. wholesale prices for generic betamethasone dipropionate creams fell from $50 per tube in 2015 to under $20 by 2023, reflecting competitive pressures.

Looking ahead, projections forecast modest growth to $600-700 million by 2030, driven by market expansion in Asia and Latin America. Factors like inflation-adjusted pricing and new indications could uplift revenues; ongoing clinical trials explore its use in combination therapies for atopic dermatitis, potentially adding $100 million annually if approved. However, risks loom, including regulatory crackdowns on corticosteroid overuse, which could cap demand.

Investment in R&D offers upside. Companies are reformulating the drug for enhanced delivery, such as nanoparticle-based systems, to extend patent life and recapture market share. Financial models from firms like IQVIA predict a 5% CAGR for the segment, assuming stable economic conditions. Stakeholders must monitor macroeconomic factors, such as currency fluctuations, which recently impacted export revenues for Indian manufacturers by 10-15%.

Challenges and Opportunities

Betamethasone dipropionate faces significant challenges, including patent erosion and generic competition, which compress margins and stifle innovation. In the U.S., over 80% of prescriptions now go to generics, eroding brand profitability. Regulatory scrutiny intensifies, with agencies like the EMA imposing restrictions on long-term use due to side effects like skin atrophy, potentially reducing market volume by 5-10% in the next five years.

Opportunities arise from demographic shifts and technological advancements. An aging global population increases demand for chronic condition treatments, while digital tools like AI-driven diagnostics enhance early detection. Partnerships, such as those between pharmaceutical giants and biotech firms, could yield next-generation formulations, extending the drug's lifecycle. For instance, emerging markets in Africa present untapped potential, with demand projected to grow 15% annually as healthcare access improves.

Sustainability initiatives also open doors; companies adopting green manufacturing processes gain competitive edges through eco-labels and consumer preferences. Financially savvy firms can leverage these by investing in acquisitions or licensing deals, as seen with Teva's strategic expansions. Ultimately, navigating these dynamics requires agility, blending cost control with innovation to sustain long-term viability.

Conclusion and Key Takeaways

In summary, betamethasone dipropionate's market dynamics reflect a mature pharmaceutical asset adapting to competitive and regulatory pressures, while its financial trajectory points to steady, if modest, growth. Business professionals must weigh these factors to optimize strategies in dermatology investments.

Key Takeaways

• Market growth hinges on emerging regions, with Asia-Pacific driving a 6% CAGR through 2030 amid rising healthcare demands.
• Generic dominance pressures pricing, reducing revenues by 40% post-patent but stabilizing through volume gains.
• Regulatory challenges limit expansion, yet innovation in formulations could add $100 million in annual sales.
• Financial projections remain positive, forecasting $600-700 million in global revenues by 2030, contingent on economic stability.
• Opportunities in partnerships and tech enable differentiation, helping firms counteract commoditization risks.

FAQs

1. What factors primarily drive the demand for betamethasone dipropionate?
   Demand stems from the rising prevalence of skin conditions like eczema and psoriasis, particularly in aging populations, with telemedicine accelerating prescriptions in developed markets.

2. How has the expiration of patents affected its financial performance?
   Patent expiration led to a 40% revenue decline for brand versions, as generics captured market share, but overall sales stabilized through increased volumes in cost-sensitive regions.

3. What role do regulations play in the market for this drug?
   Regulations from bodies like the FDA ensure safety and bioequivalence for generics, influencing approval timelines and restricting over-the-counter sales to maintain prescription control.

4. Are there emerging opportunities for growth in this market?
   Yes, opportunities include reformulated products for new indications and expansion into underserved markets like Africa, where demand could grow by 15% annually.

5. How might economic factors impact its future trajectory?
   Currency fluctuations and inflation could affect export revenues and pricing, potentially reducing margins by 10-15% for manufacturers in volatile economies.

Sources

1. IQVIA Institute for Human Data Science. "Global Use of Medicines 2023 Outlook." Report on pharmaceutical market trends and projections.
2. Grand View Research. "Topical Corticosteroids Market Size, Share & Trends Analysis Report, 2023-2030." Data on market dynamics and revenue estimates.