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Last Updated: December 22, 2024

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - Generic Drug Details


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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 Taro, 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-four patent family members in thirty-two countries.

Seven suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Recent Clinical Trials for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

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

SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Celgene CorporationPhase 4

See all BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
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
Cosette CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 210765-001 May 11, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Padagis Israel CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 200174-001 Dec 12, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Glenmark Pharms Ltd CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 214688-001 Mar 21, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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; CALCIPOTRIENE

International Patents for BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

Country Patent Number Title Estimated Expiration
Portugal 3768241 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2019179958 ⤷  Subscribe
Hong Kong 1182321 含有維生素 類似物和皮質類固醇的藥用噴霧劑組合物 (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN ANALOGUE AND A CORTICOSTEROID) ⤷  Subscribe
Canada 3093999 COMPOSITIONS TOPIQUES COMPRENANT DES DISPERSIONS DE POLYAPHRONS (TOPICAL COMPOSITIONS COMPRISING POLYAPHRON DISPERSIONS) ⤷  Subscribe
Poland 3768241 ⤷  Subscribe
Spain 2529506 ⤷  Subscribe
China 111867563 局部组合物 (TOPICAL COMPOSITION) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Calcipotriene and Betamethasone Dipropionate

Introduction

Calcipotriene and betamethasone dipropionate, a fixed-dose combination of a vitamin D analog and a corticosteroid, have been widely used in the treatment of plaque psoriasis. This combination has shown significant efficacy and patient preference, influencing its market dynamics and financial trajectory.

Efficacy and Clinical Outcomes

The combination of calcipotriene and betamethasone dipropionate has demonstrated strong clinical outcomes. In a Phase 3 trial, Wynzora cream, a formulation of this combination, achieved a Physician Global Assessment (PGA) treatment success of 52% and a 68% reduction in the modified Psoriasis Area and Severity Index (mPASI) at week 4, outperforming Daivobet gel[1].

Market Acceptance and Patient Preference

Patient-reported outcomes have been favorable, with significant improvements in treatment convenience and quality of life. The use of PAD Technology by MC2 Therapeutics has made Wynzora cream a once-daily, non-greasy product that absorbs quickly into the skin, enhancing patient compliance and satisfaction[1].

Cost-Effectiveness Analysis

Several studies have highlighted the cost-effectiveness of calcipotriene and betamethasone dipropionate formulations. A budget impact model in the US showed that the introduction of calcipotriene and betamethasone dipropionate foam could decrease the annual cost of treatment for moderate-to-severe psoriasis by $36,112,572 for a healthcare plan with 1 million members. This reduction is due to the lower per-patient cost of achieving a Psoriasis Area and Severity Index (PASI)-75 response compared to biologics[2].

In the UK, a cost-utility analysis indicated that the two-compound formulation (TCF) of calcipotriol and betamethasone dipropionate generated annual savings ranging from £96 to £276 per patient compared to other commonly used topicals, making it a cost-effective option for the National Health Service (NHS)[3].

Financial Impact on Healthcare Systems

The financial impact of adopting calcipotriene and betamethasone dipropionate formulations is significant. For a hypothetical US healthcare plan, the introduction of this foam formulation is expected to lower the cost of treatment per member per month (PMPM) by $3.00, from $16.80 to $13.80[2].

In Australia, a Markov model showed that while calcipotriene and betamethasone dipropionate foam is more expensive than the gel formulation, it provides higher quality-adjusted life years (QALYs), making it the most cost-effective option over a one-year period[5].

Market Competition and Product Variations

The market for calcipotriene and betamethasone dipropionate includes various formulations such as ointments, gels, scalp suspensions, and foams. The introduction of new formulations, like Wynzora cream and Enstilar foam, has expanded treatment options and improved patient preference due to their cosmetic acceptability and ease of use[4].

Regulatory Approvals and Expansion

The FDA and EU regulatory bodies have approved several formulations of calcipotriene and betamethasone dipropionate. For instance, Wynzora cream is under FDA review, and its approval is expected to further solidify the market position of this combination therapy[1].

Patient and Physician Satisfaction

Both patients and physicians have expressed high satisfaction with calcipotriene and betamethasone dipropionate formulations. The convenience and efficacy of these products have made them a preferred choice in daily treatment routines, as highlighted by Jesper Lange, CEO of MC2 Therapeutics: "Wynzora Cream takes the treatment experience in daily routines to a new level... Our PAD Technology has enabled an aqueous cream formulation that is designed for high convenience in daily routines"[1].

Long-Term Financial Projections

Given the cost-effectiveness and high patient satisfaction, long-term financial projections for calcipotriene and betamethasone dipropionate formulations are positive. As more healthcare systems adopt these formulations, the overall cost of treating psoriasis is expected to decrease, leading to significant savings.

Example of Cost Savings

"The introduction of C/BD foam is expected to decrease the annual COT for moderate-to-severe psoriasis treatable with biologics by $36,112,572 for a hypothetical US healthcare plan with 1 million plan members, and to lower the COT PMPM by $3.00"[2].

Conclusion

The combination of calcipotriene and betamethasone dipropionate has established itself as a highly effective and cost-effective treatment for plaque psoriasis. Its market dynamics are driven by strong clinical outcomes, patient preference, and significant cost savings for healthcare systems.

Key Takeaways

  • Efficacy: Calcipotriene and betamethasone dipropionate formulations have shown high efficacy in treating plaque psoriasis.
  • Cost-Effectiveness: These formulations are more cost-effective compared to biologics and other topical treatments.
  • Patient Preference: New formulations like Wynzora cream and Enstilar foam offer improved convenience and cosmetic acceptability.
  • Regulatory Approvals: Multiple formulations have been approved by regulatory bodies in the US and EU.
  • Financial Impact: Significant cost savings are expected for healthcare systems adopting these formulations.

FAQs

Q: What are the primary benefits of using calcipotriene and betamethasone dipropionate for psoriasis? A: The primary benefits include high efficacy, cost-effectiveness, and improved patient convenience and satisfaction.

Q: How do calcipotriene and betamethasone dipropionate formulations compare to biologics in terms of cost? A: These formulations are significantly cheaper than biologics, with a lower per-patient cost to achieve a PASI-75 response.

Q: What is the impact of PAD Technology in Wynzora cream? A: PAD Technology makes Wynzora cream a once-daily, non-greasy product that absorbs quickly into the skin, enhancing patient compliance and satisfaction.

Q: Are there any regulatory approvals for calcipotriene and betamethasone dipropionate formulations? A: Yes, several formulations have been approved by the FDA and EU regulatory bodies.

Q: How do different formulations of calcipotriene and betamethasone dipropionate compare in terms of cost-effectiveness? A: Foam and cream formulations are generally more cost-effective and offer better patient outcomes compared to traditional ointment and gel formulations.

Sources

  1. AJMC: Calcipotriene, Betamethasone Dipropionate Cream Meets Phase 3 Trial Endpoints.
  2. PubMed: Budget impact model in moderate-to-severe psoriasis vulgaris.
  3. PubMed: Cost-effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate.
  4. FDA: 207589Orig1s000 - accessdata.fda.gov.
  5. PubMed: A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate foam and gel for the treatment of people with plaque psoriasis.

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