Halobetasol propionate; tazarotene - Generic Drug Details

What are the generic sources for halobetasol propionate; tazarotene and what is the scope of patent protection?

Halobetasol propionate; tazarotene is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate; tazarotene has fifty-four patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for halobetasol propionate; tazarotene

International Patents:	54
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for halobetasol propionate; tazarotene
DailyMed Link:	halobetasol propionate; tazarotene at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for halobetasol propionate; tazarotene

Constraining patent/regulatory exclusivity:

10,478,502

Dosage:

LOTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for halobetasol propionate; tazarotene

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

Sponsor	Phase
Dermatology Consulting Services, PLLC	Phase 4
Taro Pharmaceuticals USA	Early Phase 1
Icahn School of Medicine at Mount Sinai	Phase 4

See all halobetasol propionate; tazarotene clinical trials

Pharmacology for halobetasol propionate; tazarotene

Drug Class	Corticosteroid Retinoid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for halobetasol propionate; tazarotene

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE; TAZAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUOBRII	Lotion	halobetasol propionate; tazarotene	0.01%/0.045%	209354	1	2020-06-11

US Patents and Regulatory Information for halobetasol propionate; tazarotene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,679,115		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,839,656
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	10,478,502		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	12,076,403		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	8,809,307		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,648,256		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,986,527

Expired US Patents for halobetasol propionate; tazarotene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	6,517,847

International Patents for halobetasol propionate; tazarotene

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3621614	COMPOSITIONS TOPIQUES ET MÉTHODES DE TRAITEMENT DE MALADIES CUTANÉS (TOPICAL COMPOSITIONS AND METHODS FOR TREATING SKIN DISEASES)
South Korea	20180015281	국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Canada	2817524	FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Slovenia	2643002
Brazil	112013012476	formulações farmacêuticas contendo corticosteróides para administração tópica
Japan	6997624
European Patent Office	3310389	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE ET UN RÉTINOÏDE POUR LE TRAITEMENT DU PSORIASIS (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)

Halobetasol propionate; tazarotene Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Halobetasol Propionate and Tazarotene

Introduction

Halobetasol propionate and tazarotene, combined in the topical lotion known as Duobrii, have revolutionized the treatment of plaque psoriasis. This combination therapy, approved by the FDA in 2019, has shown significant clinical efficacy and has been well-received in the dermatological market.

Clinical Efficacy and Market Impact

The combination of halobetasol propionate, a potent corticosteroid, and tazarotene, a retinoid, has demonstrated clinically meaningful improvements in patients with moderate to severe plaque psoriasis. Studies have shown that this combination therapy results in rapid and sustained skin clearance, with significant improvements observed as early as week 2 and sustained through week 12[1][4].

This efficacy has translated into a strong market presence, as Duobrii addresses a critical need for effective topical treatments for plaque psoriasis. The synergy between halobetasol propionate and tazarotene not only reduces inflammation and keratinocyte hyperproliferation but also normalizes keratinocyte differentiation, making it a preferred option for dermatologists and patients alike[4].

Market Competition

The psoriasis treatment market is highly competitive, with various topical and systemic therapies available. However, the unique combination of halobetasol propionate and tazarotene sets Duobrii apart. Other recent advancements in topical treatments, such as tapinarof, roflumilast, and brepocitinib, are also vying for market share, but Duobrii's established track record and dual mechanism of action give it a competitive edge[3].

Regulatory Approval and Safety Profile

The FDA approval of Duobrii in 2019 marked a significant milestone. The regulatory pathway involved extensive nonclinical and clinical studies, ensuring the safety and efficacy of the combination therapy. The safety profile of Duobrii is characterized by mild to moderate application site reactions, which are common in the first 12 weeks of treatment. Long-term safety data indicate that the therapeutic effect can be maintained even after treatment cessation, further enhancing its market appeal[2][4].

Financial Performance

The financial trajectory of Duobrii has been positive since its launch. The drug's effectiveness and the lack of significant toxicological interactions between halobetasol propionate and tazarotene have contributed to its commercial success. As more patients and healthcare providers become aware of the benefits of this combination therapy, sales are expected to continue growing.

Prescription Trends and Patient Compliance

Prescription trends indicate a steady increase in the use of Duobrii, driven by its rapid onset of action and sustained therapeutic effects. Patient compliance is also high due to the once-daily application regimen and the noticeable improvements in skin clearance. This compliance is crucial for maintaining market share and driving revenue growth[4].

Payer and Reimbursement Landscape

The reimbursement landscape for Duobrii is favorable, with many insurance plans covering the treatment. The cost-effectiveness of Duobrii, particularly when compared to systemic therapies or other combination treatments, makes it an attractive option for both patients and payers. This favorable reimbursement environment has helped in expanding the drug's reach and adoption[5].

Future Outlook and Expansion

The future outlook for Duobrii is promising. Ongoing studies and real-world evidence continue to support its efficacy and safety profile. The potential for intermittent use for up to one year, as suggested by some studies, could further enhance its market position. Additionally, the lack of systemic accumulation and the reversibility of adverse effects observed in clinical trials bode well for long-term market sustainability[2][4].

Key Takeaways

• Clinical Efficacy: Duobrii has demonstrated significant and sustained skin clearance in patients with moderate to severe plaque psoriasis.
• Market Impact: The combination therapy has established a strong market presence due to its unique dual mechanism of action.
• Safety Profile: The drug is well-tolerated with mild to moderate application site reactions.
• Financial Performance: The financial trajectory is positive, driven by increasing prescriptions and patient compliance.
• Future Outlook: The future looks promising with ongoing studies supporting its efficacy and safety.

FAQs

1. What is Duobrii, and how does it work?

Duobrii is a topical lotion combining halobetasol propionate and tazarotene. It works by reducing inflammation and keratinocyte hyperproliferation through the corticosteroid action of halobetasol propionate and normalizing keratinocyte differentiation through the retinoid action of tazarotene[1][5].

2. What are the common side effects of Duobrii?

Common side effects include mild to moderate application site reactions such as redness, itching, and swelling. These reactions are typically observed in the first 12 weeks of treatment[4].

3. How is Duobrii administered?

Duobrii is administered once daily as a topical lotion. It is applied directly to the affected skin areas[5].

4. Is Duobrii covered by insurance?

Yes, Duobrii is covered by many insurance plans, making it a cost-effective option for patients with plaque psoriasis[5].

5. Can Duobrii be used intermittently?

Yes, studies have shown that Duobrii can be safely used intermittently for up to one year, maintaining its therapeutic effect even after treatment cessation[4].

References

1. Halobetasol Propionate, Tazarotene Lotion Demonstrates Clinically Significant Skin Clearance in Hyperkeratotic Psoriasis - HCPLive
2. Multi-Discipline Review - DUOBRII (halobetasol and tazarotene) Lotion, 0.01%/0.045% - FDA
3. Recent Advancements and Trends of Topical Drug Delivery Systems in Psoriasis - DovePress
4. Fixed Combination Tazarotene and Halobetasol Propionate for Moderate-to-Severe Plaque Psoriasis - University of Alberta
5. Halobetasol and tazarotene (topical application route) - Mayo Clinic