TARGRETIN Drug Patent Profile

Which patents cover Targretin, and when can generic versions of Targretin launch?

Targretin is a drug marketed by Valeant Luxembourg and Bausch and is included in two NDAs.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Targretin

A generic version of TARGRETIN was approved as bexarotene by BIONPHARMA on August 12^th, 2014.

Summary for TARGRETIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	30
Patent Applications:	5,189
Drug Prices:	Drug price information for TARGRETIN
What excipients (inactive ingredients) are in TARGRETIN?	TARGRETIN excipients list
DailyMed Link:	TARGRETIN at DailyMed

See drug prices for TARGRETIN

Recent Clinical Trials for TARGRETIN

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

Sponsor	Phase
National Cancer Centre, Singapore	Phase 1
National Medical Research Council (NMRC), Singapore	Phase 1
The Cleveland Clinic	Phase 2

See all TARGRETIN clinical trials

Pharmacology for TARGRETIN

Drug Class

Retinoid

US Patents and Regulatory Information for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999	AB	RX	Yes	Yes
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	AB	RX	Yes	Yes

Expired US Patents for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000

EU/EMA Drug Approvals for TARGRETIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Targretin	bexarotene	EMEA/H/C/000326 Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.	Authorised	no	no	no	2001-03-29

International Patents for TARGRETIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	195716
Japan	H08505852
Mexico	9306629	COMPUESTOS QUE TIENEN ACTIVIDAD SELECTIVA PARA RECEPTORES RETINOIDE X, MEDIOS PARA MODULACION DE PROCESOS MEDIADOS PR RECEPTORES DE RETINOIDE X.
Austria	187434
Brazil	9307528

Supplementary Protection Certificates for TARGRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0637297	C300054	Netherlands		PRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329
0637297	SPC/GB01/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016.
0637297	01C0027	France		PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
0637297	CA 2001 00032	Denmark
0637297	SPC013/2001	Ireland		SPC013/2001: 20031205, EXPIRES: 20160328

TARGRETIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Targretin (Bexarotene)

Introduction

Targretin, also known as bexarotene, is a significant drug in the treatment of cutaneous T-cell lymphoma (CTCL), particularly for patients who are refractory to at least one prior systemic therapy. Here, we will delve into the market dynamics and financial trajectory of Targretin, highlighting its approval history, market presence, and the companies involved in its commercialization.

Approval History and Regulatory Milestones

Targretin was first approved by the US FDA in 1999 with an orphan designation for the treatment of CTCL. This initial approval marked the beginning of its global journey, and as of December 2022, Targretin is available in 36 countries or regions[1].

Recent Approvals in Asia

A significant milestone in the market dynamics of Targretin was the recent marketing authorization in Hong Kong and Macau. Main Life Corp., Ltd. announced the approval of Targretin capsules in Hong Kong for the treatment of cutaneous manifestations of CTCL, marking the first commercial availability of the drug in China[1].

Market Presence and Clinical Guidelines

Targretin is recommended as a treatment option in major clinical guidelines, including those by the National Comprehensive Cancer Network (NCCN) and the European Organisation for Research and Treatment of Cancer (EORTC). This endorsement by prestigious medical organizations underscores its importance in the treatment of CTCL[1].

Mechanism of Action

Targretin contains bexarotene, a type of retinoid that selectively binds to the retinoid X receptor (RXR). This binding suppresses tumor growth by inducing apoptosis and cell cycle arrest, making it an effective treatment for CTCL[1].

Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a rare type of primary cutaneous lymphoma characterized by the proliferation and manifestations of T-cells in the skin. The two most common subtypes are mycosis fungoides and Sézary syndrome. CTCL can progress slowly over several years to decades, making effective treatments like Targretin crucial for patient care[1].

Commercialization and Licensing Agreements

The development and commercialization of Targretin in Asia were facilitated by a licensing agreement between Minophagen Pharmaceutical Co., Ltd. and Eisai Co., Ltd. in 2012. Minophagen launched Targretin in Japan in 2016 and has since obtained an Investigational New Drug approval to initiate clinical trials in mainland China. Main Life Corp., Ltd. has an exclusive agreement with Minophagen for the commercialization of Targretin in Hong Kong and Macau[1].

Financial Trajectory

The financial trajectory of Targretin is closely tied to the performance of the companies involved in its commercialization. Here are some key financial aspects:

Revenue Potential

Given its status as a standard-of-care drug in international clinical practice, Targretin has significant revenue potential. The drug's availability in new markets, such as Hong Kong and Macau, and its ongoing clinical trials in mainland China, are expected to contribute to its revenue growth.

Market Expansion

The expansion into new geographies, particularly in Asia, is a key driver of Targretin's financial trajectory. As the drug becomes available in more countries, it is likely to capture a larger market share, thereby increasing its revenue.

Competitive Landscape

In the competitive landscape of oncology drugs, Targretin's unique mechanism of action and its endorsement by major clinical guidelines position it favorably. However, the presence of other treatments and the ongoing development of new therapies could impact its market share and financial performance.

Company Performance

Main Life Corp., Ltd. and Minophagen Pharmaceutical Co., Ltd. are the primary companies involved in the commercialization of Targretin. Their financial performance, particularly in the regions where Targretin is being commercialized, will be crucial in determining the drug's overall financial trajectory.

Industry Expert Insights

Industry experts highlight the importance of Targretin in the treatment of CTCL. For example, the approval in Hong Kong and Macau is seen as a significant step in improving the quality of life for patients with this rare disease.

"Together with Minophagen, Main Life strives to improve the quality of life of patients in the region by offering Targretin as a new treatment option for patients living with CTCL."[1]

Illustrative Statistics

• Global Availability: As of December 2022, Targretin is available in 36 countries or regions[1].
• Market Expansion: The recent approvals in Hong Kong and Macau mark the first commercial availability of Targretin in China[1].
• Clinical Guidelines: Targretin is recommended by major treatment guidelines such as those by NCCN and EORTC[1].

Challenges and Opportunities

Regulatory Challenges

Navigating regulatory approvals in new markets is a significant challenge. However, the recent approvals in Hong Kong and Macau demonstrate the ability of the companies involved to overcome these hurdles.

Market Competition

The oncology market is highly competitive, with numerous treatments available for various types of cancer. Targretin's unique mechanism of action and its status as a standard-of-care drug help it stand out, but ongoing competition from new therapies is a constant challenge.

Patient Access

Ensuring patient access to Targretin, particularly in regions where it is newly approved, is crucial. This involves not only securing regulatory approvals but also working with healthcare systems to make the drug accessible to those who need it.

Key Takeaways

• Global Reach: Targretin is available in 36 countries or regions and has recently been approved in Hong Kong and Macau.
• Clinical Significance: It is a standard-of-care drug for refractory CTCL, endorsed by major clinical guidelines.
• Mechanism of Action: Targretin works by selectively binding to the retinoid X receptor (RXR), suppressing tumor growth.
• Commercialization: Main Life Corp., Ltd. and Minophagen Pharmaceutical Co., Ltd. are key players in its commercialization.
• Financial Potential: The drug has significant revenue potential due to its market expansion and clinical importance.

FAQs

What is Targretin used for?

Targretin is used for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy.

Who are the key companies involved in the commercialization of Targretin?

Main Life Corp., Ltd. and Minophagen Pharmaceutical Co., Ltd. are the primary companies involved in the commercialization of Targretin.

What is the mechanism of action of Targretin?

Targretin contains bexarotene, which selectively binds to the retinoid X receptor (RXR) and suppresses tumor growth by inducing apoptosis and cell cycle arrest.

In which regions is Targretin newly available?

Targretin is newly available in Hong Kong and Macau, marking the first commercial availability of the drug in China.

What are the major clinical guidelines that recommend Targretin?

Targretin is recommended by major treatment guidelines such as those by the National Comprehensive Cancer Network (NCCN) and the European Organisation for Research and Treatment of Cancer (EORTC).

Sources

1. GlobeNewswire: Main Life received Targretin (Bexarotene) Marketing Authorisation in Hong Kong for Cutaneous T-Cell Lymphoma[1].