ALTRENO Drug Patent Profile

When do Altreno patents expire, and when can generic versions of Altreno launch?

Altreno is a drug marketed by Dow Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in eight countries.

The generic ingredient in ALTRENO is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Altreno

A generic version of ALTRENO was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for ALTRENO

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	2
Drug Prices:	Drug price information for ALTRENO
What excipients (inactive ingredients) are in ALTRENO?	ALTRENO excipients list
DailyMed Link:	ALTRENO at DailyMed

See drug prices for ALTRENO

Recent Clinical Trials for ALTRENO

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 4
Ortho Dermatologics	Phase 4
Bausch Health Americas, Inc.	Phase 4

See all ALTRENO clinical trials

Pharmacology for ALTRENO

Drug Class

Retinoid

US Patents and Regulatory Information for ALTRENO

ALTRENO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes			Y
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes

Expired US Patents for ALTRENO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018

International Patents for ALTRENO

See the table below for patents covering ALTRENO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	030093	SISTEMA PARA LA DISTRIBUCION TOPICA DEL GEL
China	1460013
European Patent Office	1304992	SYSTEME TOPIQUE DE DISTRIBUTION DE GEL DESTINES AU TRAITEMENT DES TROUBLES DE LA PEAU (TOPICAL GEL DELIVERY SYSTEMS FOR TREATING SKIN DISORDERS)
European Patent Office	2052714	Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders)
Japan	4988129
South Africa	200301037	Topical gel delivery system.

Supplementary Protection Certificates for ALTRENO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018

ALTRENO (Tretinoin) Market Dynamics and Financial Trajectory

Introduction to ALTRENO

ALTRENO, a formulation of tretinoin, is a topical retinoid used primarily for the treatment of acne. It was launched by Bausch Health in the United States in 2018, marking a significant milestone in the dermatology market.

Approval and Clinical Efficacy

ALTRENO Lotion, 0.05%, was approved by the U.S. Food and Drug Administration (FDA) on August 24, 2018. The approval was based on data from two identical multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies. These studies demonstrated that ALTRENO Lotion resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to the vehicle control[4].

Market Segmentation

The market for tretinoin, including ALTRENO, is segmented based on several factors:

• Indications: Acne, Acute Promyelocytic Leukemia (APL), and others. Acne treatment accounts for the largest proportion of the market[1].
• Concentration: Available in various concentrations such as 0.025%, 0.01%, 0.05%, and 0.1%[1].
• Distribution Channels: Hospitals & Clinics, Pharmacies, Retail Pharmacies, Online Pharmacies, and others[1].
• Geographical Regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa[1].

Geographical Performance

North America, particularly the United States, and Europe are the largest markets for tretinoin products, including ALTRENO. The high prevalence of acne vulgaris in these regions drives the demand for effective treatments like ALTRENO. In the Asia Pacific region, Japan is expected to provide significant market opportunities due to the presence of major drug manufacturers like Chugai[1].

Competitive Landscape

The dermatology market is highly competitive, with several retinoid products available. However, ALTRENO stands out as the first and only tretinoin available in a lotion form, which has been shown to be effective and generally well-tolerated for acne treatment[4].

Financial Performance

While specific financial data for ALTRENO alone is not readily available, the overall tretinoin market and related dermatology products provide insights into the financial trajectory:

• The global tretinoin market is expected to grow, driven by the high usage of tretinoin for acne treatment. North America and Europe are expected to continue as the largest markets[1].
• The isotretinoin market, which is closely related to tretinoin in terms of dermatological applications, is projected to grow from $1.22 billion in 2023 to $1.29 billion in 2024 at a CAGR of 5.5%. This growth trend can be indicative of the broader retinoid market, including ALTRENO[3].

Key Drivers of Growth

Several factors drive the growth of the ALTRENO market:

• Prevalence of Acne: The high incidence of acne, particularly among adolescents and young adults, continues to drive the demand for effective treatments[3].
• Skincare Trends: Growing awareness and trends in skincare contribute to increased demand for dermatological products like ALTRENO[3].
• Regulatory Approvals: The FDA approval of ALTRENO Lotion in 2018 was a significant milestone, ensuring its legitimacy and safety in the market[4].
• Marketing and Awareness: Continuous marketing and awareness campaigns by Bausch Health and other stakeholders help in increasing the adoption of ALTRENO[3].

Challenges and Adverse Reactions

While ALTRENO has been shown to be effective, it also comes with some common adverse reactions:

• Dryness, Pain, Erythema, Irritation, and Exfoliation: These are the most common adverse reactions, occurring in more than 1% of subjects and greater than the vehicle control[4].

Future Outlook

The future outlook for ALTRENO is promising, driven by several trends:

• Research and Development: Ongoing research and development in dermatology are expected to lead to improved formulations and technological advancements, which could further enhance the market position of ALTRENO[3].
• Expansion in Emerging Markets: Growing healthcare infrastructure and increasing awareness in emerging markets are likely to expand the reach of ALTRENO[3].
• Focus on Mental Health and Well-being: The increasing focus on mental health and well-being, which is often linked to skin health, is expected to drive demand for effective skincare products like ALTRENO[3].

Key Takeaways

• Effective Treatment: ALTRENO is the first and only tretinoin available in a lotion form, proven effective for acne treatment.
• Market Growth: The market is driven by the high prevalence of acne, skincare trends, and regulatory approvals.
• Geographical Performance: North America and Europe are the largest markets, with Japan in the Asia Pacific region offering significant opportunities.
• Challenges: Common adverse reactions include dryness, pain, erythema, irritation, and exfoliation.
• Future Outlook: Promising due to ongoing research, expansion in emerging markets, and a focus on mental health and well-being.

FAQs

What is ALTRENO used for?

ALTRENO is primarily used for the treatment of acne. It is a topical retinoid available in a lotion form.

When was ALTRENO approved by the FDA?

ALTRENO Lotion, 0.05%, was approved by the U.S. Food and Drug Administration (FDA) on August 24, 2018.

What are the common adverse reactions associated with ALTRENO?

Common adverse reactions include dryness, pain, erythema, irritation, and exfoliation.

Which regions are the largest markets for ALTRENO?

North America, particularly the United States, and Europe are the largest markets for ALTRENO.

What drives the growth of the ALTRENO market?

The growth is driven by the high prevalence of acne, skincare trends, regulatory approvals, and ongoing research and development in dermatology.

Sources

1. Fortune Business Insights - Tretinoin Market Size, Industry Share | Forecast 2032
2. Oregon Health Plan - Section 1115 Annual Report
3. The Business Research Company - Global Isotretinoin Drugs Market Report 2024
4. PR Newswire - Bausch Health Launches ALTRENO™ (tretinoin) Lotion, 0.05% In The United States