FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - Generic Drug Details

What are the generic sources for fluocinolone acetonide; hydroquinone; tretinoin and what is the scope of freedom to operate?

Fluocinolone acetonide; hydroquinone; tretinoin is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
DailyMed Link:	FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN at DailyMed

Recent Clinical Trials for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

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

Sponsor	Phase
Galderma Laboratories, L.P.	Phase 2
Pontificia Universidad Catolica de Chile	Phase 2
Galderma Laboratories, L.P.	Phase 4

See all FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN clinical trials

Pharmacology for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Drug Class	Corticosteroid Melanin Synthesis Inhibitor Retinoid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Melanin Synthesis Inhibitors
Physiological Effect	Depigmenting Activity

Anatomical Therapeutic Chemical (ATC) Classes for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

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

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002		RX	Yes	Yes

Expired US Patents for FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	7,915,243
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	8,653,053
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	8,247,395

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Fluocinolone Acetonide, Hydroquinone, Tretinoin

Introduction

The combination of fluocinolone acetonide, hydroquinone, and tretinoin, commonly known as Tri-Luma Cream, is a significant treatment for melasma, a skin condition characterized by patches of discoloration. This article delves into the market dynamics and financial trajectory of this drug, highlighting its efficacy, cost-effectiveness, and broader market trends.

Efficacy and Clinical Outcomes

Tri-Luma Cream has demonstrated superior efficacy in treating melasma compared to single-agent treatments. Studies have shown that the triple combination therapy (TCT) achieves a 30% better rate of complete clearing than hydroquinone alone[1][4][5].

Clinical Studies

In clinical trials involving 641 patients with moderate to severe melasma, TCT was compared against combinations of two of the three active ingredients. The results indicated that TCT had a favorable safety profile and higher success rates. A 12-month study further reinforced these findings, showing that most patients experienced mild and transient application-site reactions, with only 1% withdrawing due to treatment-related adverse events[4].

Cost-Effectiveness

The cost-effectiveness of TCT is a crucial factor in its market dynamics. In the U.S., TCT has been found to have a lower cost per primary success (complete clearing) compared to hydroquinone alone. However, in other countries, TCT incurred an incremental cost, although it still maintained a lower cost per primary success[1][5].

Comparative Analysis

When compared to hydroquinone alone, TCT showed robust cost-effectiveness across various countries. The total cost per primary success was consistently lower for TCT, making it a more economical option for achieving complete clearing of melasma[1][5].

Market Trends in Prescription Drug Spending

The broader market trends in prescription drug spending play a significant role in the financial trajectory of Tri-Luma Cream.

Recent and Forecasted Trends

Retail prescription drug spending has seen significant growth over the past few decades, with a notable acceleration in 2021. However, projections suggest that this growth is expected to moderate in the next decade. The Inflation Reduction Act is anticipated to reduce aggregate drug costs and out-of-pocket spending for consumers[3].

Impact on Out-of-Pocket Spending

Out-of-pocket prescription drug spending is expected to decline by 8% by 2031, partly due to provisions from the Inflation Reduction Act. This reduction could make Tri-Luma Cream more accessible to patients, potentially increasing its market share[3].

Pricing and Affordability

The affordability of prescription drugs, including Tri-Luma Cream, is a critical issue for both consumers and policymakers.

Pricing Comparisons

While Tri-Luma Cream may be more cost-effective in terms of treatment outcomes, its pricing can vary significantly compared to other countries. The high list prices of prescription drugs in the U.S. compared to other nations can affect the drug's market dynamics and patient access[3].

Consumer Affordability

A significant portion of adults taking prescription drugs, especially those with lower household incomes, report difficulty affording their medication. This issue underscores the need for affordable pricing strategies to ensure wider accessibility of Tri-Luma Cream[3].

Safety and Long-Term Use

The safety profile of Tri-Luma Cream is another important factor influencing its market dynamics.

Long-Term Safety

A 12-month study demonstrated that Tri-Luma Cream has a favorable safety profile, with most treatment-related adverse events being mild and transient. The presence of tretinoin was found to prevent corticosteroid-induced skin atrophy, a common concern with long-term corticosteroid use[4].

Potential Risks

While the clinical studies have shown minimal systemic absorption of the active ingredients, there are some concerns regarding the long-term use of corticosteroids and hydroquinone. Animal studies have indicated potential carcinogenic effects of hydroquinone, although the clinical relevance of these findings is unknown[2].

Regulatory and Policy Environment

The regulatory and policy environment significantly impacts the market dynamics of Tri-Luma Cream.

FDA Approval and Labeling

Tri-Luma Cream is approved by the FDA for the treatment of melasma, with specific labeling that includes warnings about potential interactions with other medications and the risk of photosensitization[2].

Policy Changes

Policy changes, such as those introduced by the Inflation Reduction Act, can influence the cost and accessibility of Tri-Luma Cream. These changes aim to reduce drug costs and out-of-pocket spending, which could positively impact the drug's market trajectory[3].

Conclusion

The combination of fluocinolone acetonide, hydroquinone, and tretinoin in Tri-Luma Cream presents a highly effective and cost-effective treatment for melasma. Its superior efficacy, favorable safety profile, and potential for reduced out-of-pocket spending make it an attractive option in the market.

Key Takeaways

• Efficacy: TCT achieves a 30% better rate of complete clearing than hydroquinone alone.
• Cost-Effectiveness: Lower cost per primary success in the U.S. and other countries.
• Market Trends: Moderate growth in prescription drug spending expected in the next decade.
• Affordability: Pricing and affordability issues remain significant, especially for lower-income households.
• Safety: Favorable long-term safety profile with minimal systemic absorption.
• Regulatory Environment: FDA approval and policy changes influence market dynamics.

FAQs

Q: What is the primary indication for Tri-Luma Cream?

A: Tri-Luma Cream is primarily indicated for the treatment of moderate to severe melasma of the face.

Q: How does the cost-effectiveness of TCT compare to hydroquinone alone?

A: TCT has a lower cost per primary success compared to hydroquinone alone, especially in the U.S., although it may incur an incremental cost in other countries.

Q: What are the common adverse events associated with Tri-Luma Cream?

A: Common adverse events include mild and transient application-site reactions such as desquamation, erythema, and dryness.

Q: How do policy changes affect the market dynamics of Tri-Luma Cream?

A: Policy changes, such as those from the Inflation Reduction Act, aim to reduce drug costs and out-of-pocket spending, making Tri-Luma Cream more accessible to patients.

Q: What are the long-term safety concerns associated with Tri-Luma Cream?

A: While the drug has a favorable safety profile, there are concerns regarding the long-term use of corticosteroids and hydroquinone, including potential skin atrophy and carcinogenic effects, although these findings are not clinically significant in human studies.

Sources

1. Cost-effectiveness of a fixed combination of hydroquinone/tretinoin/fluocinolone acetonide cream compared with hydroquinone alone in the treatment of melasma. PubMed.
2. TRI-LUMA Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%). FDA.
3. Recent and forecasted trends in prescription drug spending. Health System Tracker.
4. A Safe and Efficacious 12-Month Treatment for Melasma. MDedge.
5. Cost-Effectiveness of a Fixed Combination of Hydroquinone/Tretinoin/Fluocinolone Cream Compared With Hydroquinone Alone. Journal of Dermatology and Dermatologic Surgery.