TAZAROTENE - Generic Drug Details

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

Tazarotene is the generic ingredient in five branded drugs marketed by Mayne Pharma, Allergan, Cosette, Fougera Pharms Inc, Padagis Israel, Taro, Solaris Pharma Corp, and Bausch, and is included in twelve NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tazarotene has fifty-two patent family members in twenty-four countries.

There are eight drug master file entries for tazarotene. Eleven suppliers are listed for this compound.

Summary for TAZAROTENE

International Patents:	52
US Patents:	5
Tradenames:	5
Applicants:	8
NDAs:	12
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	53
Patent Applications:	6,684
Drug Prices:	Drug price trends for TAZAROTENE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAZAROTENE
What excipients (inactive ingredients) are in TAZAROTENE?	TAZAROTENE excipients list
DailyMed Link:	TAZAROTENE at DailyMed

See drug prices for TAZAROTENE

Recent Clinical Trials for TAZAROTENE

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

Sponsor	Phase
Ortho Dermatologics	Phase 4
Dermatology Consulting Services, PLLC	Phase 4
Zagazig University	Phase 2

See all TAZAROTENE clinical trials

Pharmacology for TAZAROTENE

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for TAZAROTENE

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

Paragraph IV (Patent) Challenges for TAZAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARAZLO	Topical Lotion	tazarotene	0.045%	211882	1	2022-05-12

US Patents and Regulatory Information for TAZAROTENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solaris Pharma Corp	TAZAROTENE	tazarotene	GEL;TOPICAL	213644-001	Mar 20, 2023	AB	RX	No	No
Padagis Israel	TAZAROTENE	tazarotene	GEL;TOPICAL	213079-002	Apr 25, 2023	AB	RX	No	No
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	AB	RX	Yes	Yes
Padagis Israel	TAZAROTENE	tazarotene	GEL;TOPICAL	213079-001	Apr 25, 2023	AB	RX	No	No

Expired US Patents for TAZAROTENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ARAZLO	tazarotene	LOTION;TOPICAL	211882-001	Dec 18, 2019	6,517,847
Allergan	TAZORAC	tazarotene	GEL;TOPICAL	020600-001	Jun 13, 1997	5,914,334
Allergan	TAZORAC	tazarotene	GEL;TOPICAL	020600-002	Jun 13, 1997	6,258,830
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	5,089,509

International Patents for TAZAROTENE

Country	Patent Number	Title	Estimated Expiration
Slovenia	3310389
Cyprus	1123354
Brazil	112019023817	composições tópicas e métodos para o tratamento de doenças da pele
China	108282998	用于治疗银屑病的包含皮质类固醇和类视黄醇的局部组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)

Supplementary Protection Certificates for TAZAROTENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730

TAZAROTENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tazarotene

Introduction to Tazarotene

Tazarotene is a topical retinoid used primarily in the treatment of various skin conditions, including psoriasis, acne, and photodamaged skin. The market for tazarotene is influenced by several key factors that drive its growth, challenges, and future outlook.

Market Drivers

Increasing Prevalence of Skin Disorders

The rising incidence of skin disorders such as psoriasis and acne is a significant driver for the tazarotene market. As the global population becomes more aware of available treatment options, the demand for effective and safe treatments for these conditions increases[1].

Advancements in Dermatological Research

Ongoing research and development in dermatology have led to the introduction of innovative and advanced therapies. Tazarotene, with its proven efficacy in managing various skin conditions, is gaining popularity among healthcare professionals and patients[1].

Growing Demand for Targeted Therapies

There is a growing demand for targeted therapies in dermatology that offer improved outcomes and reduced side effects. Tazarotene, with its specific mechanism of action, is preferred for its effectiveness and safety profile[1].

Market Restraints

Regulatory Challenges

The tazarotene market faces regulatory challenges, including the need for stringent clinical trials and approvals. These regulatory hurdles can slow down the market growth and limit the availability of new formulations[1].

Competitive Landscape

The dermatological market is highly competitive, with numerous treatments available for skin conditions. This competition can make it challenging for tazarotene to maintain market share, especially with the emergence of new therapies[1].

Market Dynamics

Technological Advancements

Technological advancements in the formulation of tazarotene, such as the introduction of foams and sprays, have improved patient convenience and treatment outcomes. These innovations are expected to continue driving market growth[1].

Regional Analysis

The tazarotene market is analyzed across key regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America currently dominates the market due to the high prevalence of skin disorders and the presence of established market players. However, the Asia Pacific region is expected to witness significant growth due to growing awareness about dermatological treatments and improving healthcare infrastructure[1].

Financial Trajectory

Revenue Growth

The tazarotene market is expected to witness a healthy Compound Annual Growth Rate (CAGR) during the forecast period, driven by the growing demand for effective and safe treatments for skin conditions. The availability of generic versions of tazarotene is also expected to boost market growth by offering cost-effective treatment options[1].

Key Industry Developments

• Launch of Novel Formulations: Market players have introduced innovative tazarotene formulations to improve patient convenience and treatment outcomes. For example, Bausch Health has been focusing on expanding its product portfolio, including dermatological treatments, which has contributed to its revenue growth[2].

• Strategic Collaborations: Key industry players have engaged in strategic collaborations with research institutions and dermatology associations to advance the development and adoption of tazarotene-based therapies. These collaborations are crucial for driving innovation and market penetration[1].

End-User Analysis

Dermatology Clinics and Hospitals

Dermatology clinics and hospitals are the major end-users of tazarotene products, contributing significantly to market revenue. The increasing number of patients seeking treatment for skin disorders in these settings drives the demand for tazarotene[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the tazarotene market. While there were disruptions in the healthcare system and reduced patient visits to dermatology clinics, the demand for tazarotene products remained stable due to the chronic nature of skin conditions. As the situation normalizes, the market is expected to regain momentum[1].

Competitive Landscape and Market Strategies

Expansion of Product Portfolio

Manufacturers can diversify their product offerings by including tazarotene-based products, thereby expanding their market presence and catering to a broader customer base. Companies like Bausch Health have seen significant revenue growth by focusing on their diversified portfolios, including dermatological treatments[2].

Collaborations and Partnerships

Industry participants can explore collaborations and partnerships with dermatologists, hospitals, and clinics to promote tazarotene products and increase their market penetration. These partnerships are essential for addressing unmet medical needs and generating higher revenues[1].

Future Outlook

The tazarotene market is expected to witness steady growth in the coming years, driven by the increasing prevalence of skin disorders and the growing demand for effective and targeted dermatological treatments. Ongoing research and development activities, along with strategic collaborations, will contribute to the introduction of innovative tazarotene-based formulations and further propel market expansion[1].

Key Takeaways

• The tazarotene market is driven by the increasing prevalence of skin disorders and advancements in dermatological research.
• The market is expected to grow due to the demand for targeted therapies and the availability of generic versions.
• North America dominates the market, but the Asia Pacific region is expected to see significant growth.
• Technological advancements and strategic collaborations are key drivers of market growth.
• The COVID-19 pandemic had a mixed impact, but the market is expected to regain momentum as the situation normalizes.

Frequently Asked Questions (FAQs)

1. What are the primary drivers of the tazarotene market?

The primary drivers include the increasing prevalence of skin disorders such as psoriasis and acne, advancements in dermatological research, and the growing demand for targeted therapies.

2. How has the COVID-19 pandemic affected the tazarotene market?

The pandemic had a mixed impact, with temporary disruptions in healthcare services but stable demand due to the chronic nature of skin conditions. The market is expected to regain momentum as the situation normalizes.

3. Which region dominates the tazarotene market?

North America currently dominates the market due to the high prevalence of skin disorders and the presence of established market players.

4. What are the key strategies for market players to expand their presence in the tazarotene market?

Key strategies include expanding product portfolios, increasing revenue through targeted therapies, and engaging in strategic collaborations with dermatologists and healthcare institutions.

5. What is the future outlook for the tazarotene market?

The market is expected to witness steady growth driven by the increasing prevalence of skin disorders, ongoing research and development, and strategic collaborations.

Sources:

1. MarkWide Research - Tazarotene Market 2024-2032 | Size, Share, Growth
2. Bausch Health Companies Inc. - 2022 ANNUAL REPORT