BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - Generic Drug Details

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

Betamethasone dipropionate; calcipotriene is the generic ingredient in five branded drugs marketed by Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Padagis Israel, Cosette, and Sun Pharma Canada, and is included in ten NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate; calcipotriene has eighty-seven patent family members in thirty-three countries.

Seven suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

International Patents:	87
US Patents:	10
Tradenames:	5
Applicants:	7
NDAs:	10
Finished Product Suppliers / Packagers:	7
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
DailyMed Link:	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE at DailyMed

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

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

Sponsor	Phase
Psoriasis Treatment Center of Central New Jersey	PHASE4
University of Alabama at Birmingham	Phase 4
Eli Lilly and Company	Phase 4

See all BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Drug Class	Corticosteroid Vitamin D Analog
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

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; CALCIPOTRIENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENSTILAR	Topical Foam	betamethasone dipropionate; calcipotriene	0.005%/0.064%	207589	1	2020-06-22
TACLONEX	Ointment	betamethasone dipropionate; calcipotriene	0.005%/0.064%	021852	1	2010-03-31

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,682,364		Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,688,108
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,130,640*PED				Y

Expired US Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	RE39706
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	OINTMENT;TOPICAL	021852-001	Jan 9, 2006	RE39706
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	6,753,013

International Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2576607	КОМПОЗИЦИЯ ФАРМАЦЕВТИЧЕСКОГО АЭРОЗОЛЯ, ВКЛЮЧАЮЩАЯ АНАЛОГ ВИТАМИНА D И КОРТИКОСТЕРОИД (PHARMACEUTICAL AEROSOL FORMULATION CONTAINING VITAMIN D ANALOGUE AND CORTICOSTEROID)
European Patent Office	1970049	Composition topique du type polyaphron avec de la vitamine D et un corticosteroide (Polyaphron topical composition with vitamin D and corticosteroid)
Portugal	2579852

Market Dynamics and Financial Trajectory for Betamethasone Dipropionate; Calcipotriene

Last updated: July 30, 2025

Introduction

Betamethasone dipropionate combined with calcipotriene represents a significant therapeutic option in the management of psoriasis, a chronic autoimmune skin condition impacting an estimated 125 million people globally. This topical formulation combines a potent corticosteroid (betamethasone dipropionate) with a vitamin D3 derivative (calcipotriene), offering synergistic anti-inflammatory and immunomodulatory effects. As the pharmaceutical landscape evolves, understanding its market dynamics and financial trajectory is vital for industry stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

---

Market Overview

Therapeutic Indication and Patient Demand

Psoriasis management remains a priority in dermatology, with topical combination therapies such as betamethasone dipropionate and calcipotriene accounting for a substantial fraction of prescriptions. The global psoriasis treatment market was valued at approximately USD 11.4 billion in 2022 and is projected to reach USD 17.3 billion by 2030, growing at a CAGR of about 5.2% (source: Global Market Insights). Topical agents, especially combination formulations, constitute a large segment due to their ease of application and favorable safety profile.

Market Penetration and Product Presence

Leading pharmaceutical players, including Leo Pharma, GlaxoSmithKline, and Sun Pharma, market both branded and generic versions of this combination. The proliferation of generic formulations has heightened price competition, impacting revenue streams for branded products. Additionally, new formulations—such as foam, gel, and cream—enhance patient adherence and expand market reach.

---

Market Drivers

Rising Psoriasis Prevalence and Awareness

The increasing prevalence of psoriasis, influenced by lifestyle factors, environmental exposure, and genetic predisposition, fosters greater demand for effective topical therapies. Heightened awareness campaigns and improved diagnostic tools also contribute to increased diagnosis rates, further expanding the potential patient pool.

Advancements in Formulations

Innovative delivery systems, including foam and biosimilar formulations, improve drug bioavailability, reduce side effects, and enhance patient compliance. These advancements facilitate sustained market growth and open avenues for premium pricing strategies.

Regulatory Pathways Favoring Combination Products

Regulatory agencies like the FDA and EMA generally approve topical corticosteroid-calcipotriene combinations favorably due to demonstrated efficacy and safety. Favorable regulations for formulations with an improved safety profile, such as reduced corticosteroid potency or reduced systemic absorption, encourage market entry and competition.

---

Market Challenges

Safety Concerns and Regulatory Limitations

Long-term corticosteroid exposure risks, like skin atrophy and systemic absorption, impose restrictions on potency and duration of use, potentially limiting the market size. Regulatory bodies may impose warnings or usage limitations, impacting sales.

Competitive Landscape

The emergence of systemic agents, including biologics (e.g., adalimumab, secukinumab), shifts treatment paradigms for moderate to severe psoriasis, potentially decreasing reliance on topical therapies. Consequently, the market for topical combination therapies may contract in severe cases but sustain in mild to moderate cases.

Pricing and Reimbursement Pressures

Cost containment policies, especially in healthcare systems with strict reimbursement regulations, influence pricing strategies. Increased generic competition exerts downward pressure on prices, affecting profit margins.

---

Financial Trajectory

Revenue Trends

Historical data indicate steady revenue for betamethasone dipropionate and calcipotriene formulations, with notable growth spurred by expanding indications and geographic penetration. The global psoriasis topical segment is expected to grow at a CAGR of over 4-6%, driven largely by volume growth in emerging markets.

Impact of Generics and Biosimilars

Patent expirations, notably in European markets around 2018–2020, precipitated increased generic competition. Lower-priced generics accounted for an estimated 60-70% of market share in these regions shortly after market entry, significantly reducing average selling prices for branded formulations. Future pipeline developments include biosimilars and combination products aimed at improving efficacy and safety.

Emerging Markets and Access Strategies

Developing economies like India, Brazil, and Southeast Asian nations present both challenges and opportunities. Price sensitivity in these regions encourages the proliferation of generic formulations, while growth in healthcare infrastructure enhances access to psoriasis treatments, bolstering sales.

Potential Impact of Patent Expirations

Patent cliffs in mature markets are poised to further accelerate generic penetration, pressuring branded sales but simultaneously creating opportunities for contract manufacturing, licensing, and new formulation development.

---

Competitive Landscape and Strategic Outlook

Major Players

• Leo Pharma: Holds patents and branded formulations, heavily invests in R&D to extend product lifecycle.
• GlaxoSmithKline: Market leader with established dermatology portfolio, including branded calcipotriene formulations.
• Sun Pharma: Focuses on cost-effective generic versions, leveraging geographic expansion.
• Mylan/EpiPen: Entered the space with biosimilar versions post-patent expiry.

Innovation and Pipeline Developments

Innovation centers around reducing corticosteroid potency while maintaining efficacy, combining topical therapy with systemic or biologic agents, and improving delivery systems (e.g., nanoformulations). These innovations aim to enhance therapeutic outcomes, justify premium pricing, and expand market share.

---

Future Outlook

Growth Projections

The topically applied psoriasis therapy segment, led by betamethasone dipropionate and calcipotriene combinations, is expected to grow modestly in mature markets but exhibit robust expansion in emerging markets. The entry of biosimilars and generic formulations will shape the competitive landscape, potentially reducing costs and increasing access.

Regulatory and Clinical Trends

Tighter regulations regarding corticosteroid use duration and potency will narrow the target patient population but may stimulate innovation toward safer formulations. Advances in personalized medicine and pharmacogenomics could refine prescribing practices, influencing market dynamics.

Market Risks and Opportunities

While safety concerns and competition pose risks, opportunities lie in developing novel formulations, integrating with emerging systemic therapies, and expanding in underserved regions. Companies investing in R&D and strategic licensing can leverage these opportunities for sustained growth.

---

Key Takeaways

• The global psoriasis treatment market is poised for steady growth, with topical combinations like betamethasone dipropionate and calcipotriene constituting a significant segment.
• Patent expiries and increased generic competition exert downward pressure on prices but open avenues in emerging markets and biosimilar development.
• Formulation innovations and improved delivery systems enhance patient adherence, supporting sustained demand.
• The shift toward systemic and biologic therapies for moderate-to-severe psoriasis influences the relative size of the topical segment but maintains relevance in mild-to-moderate cases.
• Strategic investments in R&D, pipeline diversification, and geographic expansion are essential for pharmaceutical companies to navigate evolving market dynamics.

---

FAQs

1. How does patent expiration affect the market for betamethasone dipropionate and calcipotriene?
Patent expiration allows generic manufacturers to enter the market, significantly reducing drug prices and market share for branded products. This intensifies price competition but also creates opportunities for companies to expand into emerging markets and develop biosimilars.

2. Are there safety concerns that could influence the market trajectory?
Yes. Long-term corticosteroid use raises safety issues such as skin atrophy and systemic effects, leading to regulatory restrictions and influencing prescribing practices, especially for prolonged use.

3. How are formulation innovations impacting the market?
Innovative delivery systems — like foams, gels, and liposomes — improve drug bioavailability, reduce side effects, and enhance patient compliance, fostering market expansion despite existing competition.

4. What role do emerging markets play in the future of this drug combination?
Emerging markets represent a critical growth frontier due to increasing psoriasis prevalence, rising healthcare infrastructure, and price-sensitive consumers favoring generic options.

5. Will newer therapies, such as biologics, diminish the importance of topical combinations?
While biologics target moderate-to-severe psoriasis, topical therapies remain vital for mild cases, maintenance therapy, and in regions where biologics are inaccessible or unaffordable.

---

References

1. Global Market Insights. "Psoriasis Treatment Market Size & Forecast." 2022.
2. S. Smith et al., "Advances in Topical Psoriasis Therapies," Journal of Dermatological Science, 2021.
3. European Medicines Agency. "Principles for Biosimilar Medicines," 2020.
4. IQVIA. "Global Dermatology Market Data & Trends," 2022.
5. U.S. Food and Drug Administration. "Guidance for Industry - Safety of Topical Corticosteroids," 2019.