Tretinoin - Generic Drug Details

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

Tretinoin is the generic ingredient in ten branded drugs marketed by Barr Labs Inc, Endo Operations, Glenmark Pharms Ltd, Cheplapharm, Mylan Pharms Inc, Valeant Pharms North, Bausch, Valeant Bermuda, Alembic, Allergan, Padagis Us, Taro, Zo Skin Health, Zydus Lifesciences, Dow Pharm, Norvium Bioscience, Valeant Intl, Mylan, Encube, Teva Pharms, and Wockhardt, and is included in thirty-six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tretinoin has eight patent family members in eight countries.

There are twenty-six drug master file entries for tretinoin. Twenty-six suppliers are listed for this compound.

Summary for tretinoin

International Patents:	8
US Patents:	2
Tradenames:	10
Applicants:	21
NDAs:	36
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	119
Patent Applications:	6,020
Drug Prices:	Drug price trends for tretinoin
Drug Sales Revenues:	Drug sales revenues for tretinoin
What excipients (inactive ingredients) are in tretinoin?	tretinoin excipients list
DailyMed Link:	tretinoin at DailyMed

See drug prices for tretinoin

See drug sales revenues for tretinoin

Recent Clinical Trials for tretinoin

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 2
Genentech, Inc.	Phase 2
Indonesia University	N/A

See all tretinoin clinical trials

Pharmacology for tretinoin

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for tretinoin

Antineoplastic Agents

Keratolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for tretinoin

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

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

Paragraph IV (Patent) Challenges for TRETINOIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RETIN-A-MICRO	Gel	tretinoin	0.04%	020475	1	2010-12-20
RETIN-A-MICRO	Gel	tretinoin	0.1%	020475	1	2010-07-08

US Patents and Regulatory Information for tretinoin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	TRETINOIN	tretinoin	CREAM;TOPICAL	075265-001	Dec 24, 1998	AB1	RX	No	No
Padagis Us	TRETINOIN	tretinoin	CREAM;TOPICAL	075264-001	Dec 24, 1998	AB	RX	No	No
Cheplapharm	VESANOID	tretinoin	CAPSULE;ORAL	020438-001	Nov 22, 1995		DISCN	Yes	No
Zydus Lifesciences	TRETINOIN	tretinoin	CREAM;TOPICAL	218561-001	Apr 25, 2024	AB	RX	No	No
Allergan	TRETINOIN	tretinoin	CREAM;TOPICAL	202209-001	Oct 11, 2012		DISCN	No	No
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002		RX	Yes	Yes

Expired US Patents for tretinoin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-001	Feb 7, 1997	5,955,109
Bausch	RETIN-A	tretinoin	CREAM;TOPICAL	019049-001	Sep 16, 1988	3,729,568
Valeant Intl	RETIN-A	tretinoin	GEL;TOPICAL	017955-001	Approved Prior to Jan 1, 1982	3,729,568
Bausch	RETIN-A MICRO	tretinoin	GEL;TOPICAL	020475-002	May 10, 2002	5,955,109
Bausch	RETIN-A-MICRO	tretinoin	GEL;TOPICAL	020475-003	Jan 28, 2014	5,955,109
Valeant Pharms North	RETIN-A	tretinoin	CREAM;TOPICAL	017340-001	Approved Prior to Jan 1, 1982	3,729,568

International Patents for tretinoin

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
Argentina	114730	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR CONDICIONES EN LA PIEL, KIT Y MÉTODO DE TRATAMIENTO
Spain	2974819
Poland	3773641
Canada	3095937	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINEES A TRAITER DES AFFECTIONS CUTANEES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
Mexico	2020010381	COMPOSICIONES FARMACÉUTICAS TÓPICAS PARA TRATAR ENFERMEDADES CUTÁNEAS. (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS.)

Supplementary Protection Certificates for tretinoin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
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	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018

Tretinoin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tretinoin

Introduction to Tretinoin

Tretinoin, a derivative of vitamin A, is a topical medication primarily used to treat acne, signs of aging such as wrinkles and fine lines, and other dermatological conditions. Its mechanism involves increasing skin cell turnover, unclogging pores, and reducing inflammation.

Market Size and Forecast

The tretinoin market is poised for significant growth. As of 2024, the market size was valued at USD 2.5 billion and is projected to reach USD 7.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.1% during the forecast period of 2024-2031[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the tretinoin market:

Increasing Prevalence of Acne and Aging Skin

The rising prevalence of acne and the growing demand for anti-aging treatments are key drivers. Tretinoin's effectiveness in treating these conditions makes it a preferred choice among both dermatologists and consumers[3].

Advances in Formulations

Innovations in tretinoin formulations, including more stable and less irritating versions, have expanded its indications to include hyperpigmentation and other skin issues. This has further boosted market demand[3].

Patient Preference for Topical Treatments

Patients often prefer topical treatments for dermatological problems, and tretinoin's availability in various topical formulations caters to this preference, driving market demand[1].

Recommendations from Dermatologists

Dermatologists frequently recommend tretinoin for various skin issues, increasing consumer awareness and demand for products containing this ingredient[1].

Distribution Channels

Tretinoin products are available through several distribution channels:

Pharmacies and Drugstores

Over-the-counter tretinoin products are commonly found in pharmacies and drugstores[1].

Prescription Dispensing

Stronger formulations, particularly those for specific dermatological conditions, are dispensed through prescription by healthcare professionals[1].

Online Retail

The growing trend of online retail has made tretinoin-containing products accessible through e-commerce platforms, further expanding market reach[1].

Geographical Analysis

The global tretinoin market is segmented into several key regions:

North America

North America, particularly the United States and Canada, is a significant market due to the high prevalence of acne vulgaris and the early adoption of tretinoin products[4].

Europe

Europe is another major market, with countries like the U.K., Italy, Germany, and France showing strong demand for tretinoin[3][4].

Asia-Pacific

The Asia-Pacific region, especially Japan, is expected to provide substantial market opportunities due to the presence of companies like Chugai, which has released tretinoin products for various indications[4].

Middle East and Africa

The Middle East and Africa also show potential for growth, driven by increasing awareness and demand for skincare products[1][3].

Latin America

Latin America is another region with growing market dynamics, driven by expanding skincare and dermatological treatment markets[1][3].

Key Players and Market Competition

The tretinoin market is competitive, with several key players:

Major Pharmaceutical Companies

Companies such as Johnson & Johnson, Mylan N.V., Galderma S.A., Valeant Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. are prominent in the market[2].

Research and Development

Companies like Sol-Gel Technologies are focused on developing and commercializing topical drug products, including those containing tretinoin, which contributes to market innovation and growth[5].

Financial Performance and Projections

The financial trajectory of the tretinoin market is robust:

Revenue Growth

The market is expected to see significant revenue growth, driven by the increasing demand for tretinoin products across various regions and distribution channels[1][3][4].

Research and Development Investments

Companies are investing heavily in research and development to improve formulations and expand indications for tretinoin, which is expected to further drive market growth[2][5].

Market Challenges and Opportunities

While the market faces challenges such as regulatory hurdles and competition, opportunities in emerging markets and the growing awareness of skincare provide a positive outlook for future growth[2][3].

"Market growth is driven by the increasing prevalence of acne, rising demand for anti-aging treatments, and the growing awareness of skincare. Advances in formulations, including more stable and less irritating versions, as well as expanding indications for its use, further contribute to the market's expansion."[3]

Key Takeaways

• The tretinoin market is projected to grow significantly, reaching USD 7.5 billion by 2031.
• Key drivers include the increasing prevalence of acne, demand for anti-aging treatments, and patient preference for topical treatments.
• The market is segmented by distribution channels, including pharmacies, prescription dispensing, and online retail.
• North America and Europe are major markets, with Asia-Pacific and other regions showing potential for growth.
• Major pharmaceutical companies and ongoing research and development are crucial for market competition and innovation.

FAQs

What is the projected market size of tretinoin by 2031?

The tretinoin market is projected to reach USD 7.5 billion by 2031[1].

What are the primary drivers of the tretinoin market growth?

The primary drivers include the increasing prevalence of acne, rising demand for anti-aging treatments, and the growing awareness of skincare[3].

Which regions are the largest markets for tretinoin?

North America and Europe are currently the largest markets, with significant growth expected in the Asia-Pacific region as well[4].

What are the common distribution channels for tretinoin products?

Tretinoin products are available through pharmacies, prescription dispensing, and online retail[1].

Who are the key players in the tretinoin market?

Key players include Johnson & Johnson, Mylan N.V., Galderma S.A., Valeant Pharmaceuticals, and Teva Pharmaceutical Industries Ltd.[2].

What role does research and development play in the tretinoin market?

Research and development are crucial for improving formulations, expanding indications, and driving market innovation and growth[2][5].

Sources

1. Verified Market Research - Tretinoin Market Size, Share, Scope, Trends And Forecast
2. Market Research Intellect - Tretinoin Drugs Industry Market Size, Scope and Forecast Report
3. OpenPR - Tretinoin Market 2024 Trends Evaluation, Geographical Analysis, Challenges, and Investment Opportunities till 2031
4. Fortune Business Insights - Tretinoin Market Size, Industry Share | Forecast 2032
5. BioSpace - Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update