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Last Updated: July 11, 2025

BETAMETHASONE DIPROPIONATE - Generic Drug Details


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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.

Drug Prices for BETAMETHASONE DIPROPIONATE

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Drug Sales Revenue Trends for BETAMETHASONE DIPROPIONATE

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Recent Clinical Trials for BETAMETHASONE DIPROPIONATE

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

SponsorPhase
Dermavant Sciences, Inc.Phase 2/Phase 3
Wake Forest University Health SciencesPhase 2/Phase 3
Oticara Australia PTY LTDPhase 2

See all BETAMETHASONE DIPROPIONATE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE
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 ⤷  Try for Free Y ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fougera Pharms Inc BETAMETHASONE DIPROPIONATE betamethasone dipropionate OINTMENT;TOPICAL 019141-001 Sep 4, 1984 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Padagis Israel BETAMETHASONE DIPROPIONATE betamethasone dipropionate OINTMENT;TOPICAL 215847-001 Apr 12, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Taro BETAMETHASONE DIPROPIONATE betamethasone dipropionate SPRAY;TOPICAL 211722-001 Jun 17, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for BETAMETHASONE DIPROPIONATE

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

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.

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