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TRI-LUMA Drug Patent Profile

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Which patents cover Tri-luma, and when can generic versions of Tri-luma launch?

Tri-luma is a drug marketed by Galderma Labs Lp and is included in one NDA.

The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.

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Summary for TRI-LUMA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	10
Drug Prices:	Drug price information for TRI-LUMA
What excipients (inactive ingredients) are in TRI-LUMA?	TRI-LUMA excipients list
DailyMed Link:	TRI-LUMA at DailyMed

Drug patent expirations by year for TRI-LUMA

Pharmacology for TRI-LUMA

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

US Patents and Regulatory Information for TRI-LUMA

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Glossary

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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	⤷ 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 TRI-LUMA

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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	⤷ Subscribe
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	8,653,053	⤷ Subscribe
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	8,247,395	⤷ Subscribe
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	7,939,516	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TRI-LUMA

See the table below for patents covering TRI-LUMA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2006507285		⤷ Subscribe
European Patent Office	1562531	COMPOSITION DE SOIN POUR LA PEAU A APPLICATION TOPIQUE (TOPICAL SKIN CARE COMPOSITION)	⤷ Subscribe
South Korea	100852367		⤷ Subscribe
Hong Kong	1088831	TOPICAL SKIN CARE COMPOSITION	⤷ Subscribe
Poland	376715	Kompozycja terapeutyczna do skóry do stosowania miejscowego (TOPICAL SKIN CARE COMPOSITION)	⤷ Subscribe
Brazil	0314882	Composição para tratamento tópico da pele	⤷ Subscribe
Australia	2003284353	TOPICAL SKIN CARE COMPOSITION	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRI-LUMA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	132014902285293	Italy	⤷ Subscribe	PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

TRI-LUMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tri-Luma

Introduction

Tri-Luma, a prescription cream containing fluocinolone, hydroquinone, and tretinoin, is a potent treatment for moderate to severe melasma, a common skin condition characterized by dark patches on the face. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Need and Demand

Melasma is a prevalent skin condition, particularly among women and individuals with darker skin tones. The demand for effective treatments is high, driven by the aesthetic and psychological impact of the condition. Tri-Luma, with its unique combination of ingredients, addresses this need by reducing inflammation, inhibiting melanin production, and promoting skin cell turnover[1][4].

Competitive Landscape

The dermatological market for melasma treatments is competitive, with various topical and procedural options available. However, Tri-Luma's triple-action formula sets it apart, making it a preferred choice for many healthcare providers and patients. The lack of over-the-counter (OTC) alternatives for severe melasma further solidifies Tri-Luma's market position[1][4].

Pricing and Cost Considerations

The average price of a 30-gram tube of Tri-Luma in the U.S. ranges from $180 to $250, depending on the state and pharmacy. This pricing can be a significant barrier for some patients. However, the manufacturer's coupon, Galderma Care Connect Patient Card, can reduce the cost to $75 for a 30-gram tube, making it more accessible[1].

Sales and Revenue

While specific annual sales figures for Tri-Luma are not publicly disclosed, the demand for the product is steady due to its efficacy. The pharmaceutical company Galderma, which produces Tri-Luma, benefits from the consistent need for this treatment, contributing to its revenue stream.

Regulatory Environment

Tri-Luma was originally approved by the FDA in 2002 for short-term treatment of moderate to severe melasma. However, in 2009, Galderma received a warning from the FDA regarding unfounded claims about the product's use, including its duration and compatibility with other treatments. This regulatory scrutiny highlights the importance of adhering to approved usage guidelines and marketing practices[1].

Patient and Healthcare Provider Perspectives

From a patient perspective, Tri-Luma is effective but may come with potential side effects such as skin reactions, adrenal insufficiency, and Cushing’s syndrome. Healthcare providers recommend its use under strict supervision to mitigate these risks. The product's effectiveness in reducing melasma symptoms makes it a valuable option despite these considerations[1][4].

Financial Incentives and Coupons

The availability of manufacturer coupons and patient assistance programs significantly impacts the financial trajectory of Tri-Luma. These programs help reduce the financial burden on patients, increasing the likelihood of prescription fills and adherence to treatment. For example, the Galderma Care Connect Patient Card can lower the cost of Tri-Luma substantially, making it more affordable for patients[1].

Market Expansion and Access

Tri-Luma is available through prescriptions from healthcare providers and can be purchased at pharmacies. The lack of OTC availability ensures that patients are under medical supervision, which can influence market dynamics by ensuring that the product is used correctly and safely[1].

Side Effects and Safety Considerations

The potential side effects of Tri-Luma, including skin reactions, adrenal insufficiency, and Cushing’s syndrome, can impact its market dynamics. Patients and healthcare providers must weigh the benefits against the risks, which can affect prescription rates and patient compliance. Monitoring and managing these side effects are crucial for maintaining a positive market trajectory[4].

Future Outlook

Given the ongoing demand for effective melasma treatments and the unique benefits of Tri-Luma, the product is likely to maintain its market presence. However, continuous monitoring of side effects and adherence to FDA guidelines will be essential for its long-term success.

Key Statistics

Price Range: $180 to $250 for a 30-gram tube[1].
Discounted Price: $75 with the Galderma Care Connect Patient Card[1].
Approval: Originally approved by the FDA in 2002[1].
Side Effects: Skin reactions, adrenal insufficiency, Cushing’s syndrome, and others[4].

Key Takeaways

Tri-Luma is a highly effective treatment for moderate to severe melasma.
The product's unique triple-action formula sets it apart in the market.
Pricing can be a barrier, but manufacturer coupons can make it more affordable.
Regulatory compliance and safety monitoring are critical for its continued market success.
Patient and healthcare provider perspectives highlight the importance of supervised use.

FAQs

Q: What is Tri-Luma used for? A: Tri-Luma is used to treat melasma, a skin condition characterized by dark patches on the face, particularly in areas exposed to sunlight[1][4].

Q: Can Tri-Luma be purchased over the counter? A: No, Tri-Luma requires a prescription from a healthcare provider and cannot be bought over the counter[1].

Q: What are the common side effects of Tri-Luma? A: Common side effects include skin reactions such as redness, peeling, burning, dryness, itching, and acne. More severe side effects can include adrenal insufficiency and Cushing’s syndrome[4].

Q: How can I reduce the cost of Tri-Luma? A: The Galderma Care Connect Patient Card can reduce the cost of a 30-gram tube of Tri-Luma to $75[1].

Q: Why was Tri-Luma subject to an FDA warning? A: Tri-Luma was subject to an FDA warning in 2009 due to unfounded claims about its use, including its duration and compatibility with other treatments[1].

Sources

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