JENLOGA Drug Patent Profile

Which patents cover Jenloga, and what generic alternatives are available?

Jenloga is a drug marketed by Concordia Pharms Inc and is included in one NDA.

The generic ingredient in JENLOGA is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jenloga

A generic version of JENLOGA was approved as clonidine hydrochloride by ACTAVIS ELIZABETH on December 16^th, 1986.

Summary for JENLOGA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	135
Patent Applications:	1,871
DailyMed Link:	JENLOGA at DailyMed

US Patents and Regulatory Information for JENLOGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-001	Sep 30, 2009		DISCN	Yes	No
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-002	May 25, 2010		DISCN	Yes	No

Expired US Patents for JENLOGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-001	Sep 30, 2009	5,869,100
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-002	May 25, 2010	5,869,100

International Patents for JENLOGA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69534283
Australia	5259396
European Patent Office	0805677	PREPARATION DE CLONIDINE A LIBERATION PROLONGEE (EXTENDED RELEASE CLONIDINE FORMULATION)
Canada	2211325	PREPARATION DE CLONIDINE A LIBERATION PROLONGEE (EXTENDED RELEASE CLONIDINE FORMULATION)
World Intellectual Property Organization (WIPO)	9622768

JENLOGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of JENLOGA

Introduction

JENLOGA, a brand name for the drug guanfacine, is used primarily for the treatment of attention deficit hyperactivity disorder (ADHD) and, in some cases, for the management of hypertension. To understand the market dynamics and financial trajectory of JENLOGA, it is essential to delve into its sales performance, market position, and the broader pharmaceutical landscape.

Market Position and Sales Performance

Therapeutic Indications

JENLOGA is an extended-release formulation of guanfacine, which sets it apart from immediate-release versions. This extended-release mechanism enhances patient compliance and efficacy, making it a preferred option for many clinicians and patients[4].

Competitive Landscape

The ADHD treatment market is highly competitive, with several drugs available, including stimulants and non-stimulants. JENLOGA, as a non-stimulant, competes with other non-stimulant medications like Strattera (atomoxetine) and Intuniv (guanfacine immediate-release). However, its extended-release formulation gives it a unique selling point, contributing to its market share[3].

Financial Performance

Historical Sales Data

While specific and up-to-date sales figures for JENLOGA are not readily available in the provided sources, it is part of Shionogi's portfolio, which has seen significant growth through its strategic product launches and global expansions. Shionogi's overall strategy includes maximizing sales of new products, which would include JENLOGA, especially in the domestic market[5].

Revenue Contribution

Shionogi's financial reports indicate a focus on growing revenue through new and existing products. For instance, during the period of their third medium-term business plan, Shionogi aimed to increase net sales significantly, with a target of ¥280 billion by FY2014. Although JENLOGA's specific contribution is not detailed, it is part of the broader strategy to enhance earnings through new product sales[2].

Market Drivers and Challenges

Market Drivers

• Increasing Prevalence of ADHD: The growing incidence of ADHD, particularly among children and adolescents, drives the demand for effective treatments like JENLOGA.
• Extended-Release Formulation: The convenience and improved compliance associated with extended-release formulations are significant market drivers.
• Global Expansion: Shionogi's efforts to enhance its global marketing systems, particularly in the US, contribute to the potential growth of JENLOGA's sales[5].

Market Challenges

• Competitive Market: The ADHD treatment market is highly competitive, with numerous drugs available, which can make it challenging for JENLOGA to maintain or increase its market share.
• Side Effects and Adverse Reactions: Like many medications, JENLOGA can have side effects, which may limit its adoption in some cases.
• Regulatory Requirements: Stringent regulatory requirements can impact the approval and marketing of JENLOGA in various regions[4].

Strategic Initiatives and Future Outlook

Research and Development

Shionogi's focus on research and development, particularly in prioritizing diseases and developing pipeline products, is crucial for the long-term growth of JENLOGA. Innovations in drug delivery systems and exploring new therapeutic indications can further enhance its market position[5].

Global Marketing and Distribution

Enhancing global marketing systems, especially in the US, is a key strategy for Shionogi. This includes establishing strong distribution networks and collaborating with other pharmaceutical companies to expand JENLOGA's reach[2].

Key Statistics and Trends

• Market Size: While specific statistics for JENLOGA are not provided, the broader CNS stimulant drugs market, which includes ADHD treatments, is estimated to grow from USD 11.01 billion in 2024 to USD 15.01 billion by 2029, at a CAGR of 6.39%[3].
• Sales Growth: The extended-release formulation of guanfacine, such as JENLOGA, contributes to the overall growth in the ADHD treatment market, driven by its efficacy and patient compliance.

Conclusion

JENLOGA, as an extended-release formulation of guanfacine, plays a significant role in the ADHD treatment market. Its market dynamics are influenced by its unique formulation, competitive landscape, and Shionogi's strategic initiatives. While specific financial data for JENLOGA is limited, it is part of a broader pharmaceutical strategy that aims for significant growth through innovative products and global expansions.

Key Takeaways

• Unique Formulation: JENLOGA's extended-release formulation enhances patient compliance and efficacy.
• Competitive Market: The ADHD treatment market is highly competitive, but JENLOGA's unique features give it a competitive edge.
• Strategic Initiatives: Shionogi's focus on R&D, global marketing, and distribution is crucial for JENLOGA's growth.
• Market Growth: The broader CNS stimulant drugs market is expected to grow significantly, driven by increasing prevalence of ADHD and other conditions.

FAQs

1. What is JENLOGA used for? JENLOGA is used primarily for the treatment of attention deficit hyperactivity disorder (ADHD) and, in some cases, for the management of hypertension.

2. How does JENLOGA differ from other ADHD treatments? JENLOGA is an extended-release formulation of guanfacine, which enhances patient compliance and efficacy compared to immediate-release versions.

3. Who is the manufacturer of JENLOGA? JENLOGA is manufactured by Shionogi Inc.

4. What are the key market drivers for JENLOGA? Key market drivers include the increasing prevalence of ADHD, the convenience of its extended-release formulation, and Shionogi's global expansion strategies.

5. What challenges does JENLOGA face in the market? JENLOGA faces challenges such as a highly competitive market, potential side effects, and stringent regulatory requirements.