NEXICLON XR Drug Patent Profile

When do Nexiclon Xr patents expire, and what generic alternatives are available?

Nexiclon Xr is a drug marketed by Athena and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexiclon Xr

A generic version of NEXICLON XR was approved as clonidine by DIFGEN PHARMS on August 18^th, 2009.

Summary for NEXICLON XR

International Patents:	21
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	4
Patent Applications:	6,125
What excipients (inactive ingredients) are in NEXICLON XR?	NEXICLON XR excipients list
DailyMed Link:	NEXICLON XR at DailyMed

Recent Clinical Trials for NEXICLON XR

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

Sponsor	Phase
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4
Mihaela Visoiu	N/A

See all NEXICLON XR clinical trials

Pharmacology for NEXICLON XR

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

US Patents and Regulatory Information for NEXICLON XR

NEXICLON XR 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
Athena	NEXICLON XR	clonidine	TABLET, EXTENDED RELEASE;ORAL	022500-001	Dec 3, 2009		RX	No	No			Y
Athena	NEXICLON XR	clonidine	TABLET, EXTENDED RELEASE;ORAL	022500-002	Dec 3, 2009		DISCN	No	No			Y
Athena	NEXICLON XR	clonidine	TABLET, EXTENDED RELEASE;ORAL	022500-001	Dec 3, 2009		RX	No	No			Y
Athena	NEXICLON XR	clonidine	TABLET, EXTENDED RELEASE;ORAL	022500-002	Dec 3, 2009		DISCN	No	No			Y

International Patents for NEXICLON XR

See the table below for patents covering NEXICLON XR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Denmark	2428205
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Denmark	2018160
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА
Austria	E536867

NEXICLON XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NEXICLON XR

Introduction to NEXICLON XR

NEXICLON XR is a once-daily, extended-release clonidine tablet indicated for the treatment of hypertension. It is a central alpha-adrenergic agonist that reduces sympathetic outflow from the central nervous system, leading to decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure[4][5].

Market Context: Sustained Release Excipients

The market for sustained release excipients, which are crucial for the formulation of drugs like NEXICLON XR, is experiencing significant growth. This market is projected to grow at a CAGR of 7.1% to 8.5% during the forecast period from 2024 to 2033, driven by the increasing demand for controlled and targeted drug delivery systems[1][3].

Key Market Drivers

• Increasing Demand for Controlled Release Formulations: The need for medications that enhance patient compliance and provide a consistent therapeutic effect over time is a major driver. NEXICLON XR, being a once-daily medication, fits perfectly into this trend[3].
• Chronic Disease Prevalence: The rising prevalence of chronic diseases such as hypertension, diabetes, and neurological disorders further boosts the demand for sustained release formulations. In the U.S., for example, six in ten adults have a chronic disease, and four in ten have two or more chronic diseases, leading to significant healthcare costs[1].
• Advancements in Pharmaceutical Technology: Innovations in drug formulations and the adoption of novel drug delivery systems are also driving the market. The launch of NEXICLON XR in March 2022 by Athena Bioscience LLC is a recent example of such innovation[1][3].

Regional Market Analysis

• North America: This region dominates the sustained release excipients market, with a significant share attributed to advancements in drug formulations and a high demand for controlled-release medications. The U.S. extended-release excipients industry is expected to evolve significantly, driven by the progress of the pharmaceutical industry[1][3].
• Asia-Pacific: This region is expected to experience the highest CAGR during the forecast period due to expanding healthcare access, rising chronic disease prevalence, and improvements in pharmaceutical manufacturing capabilities. Countries like India and China are likely to see an increasing demand for medications with enhanced therapeutic profiles[1][3].

Financial Trajectory

• Market Size and Growth: The global sustained release excipients market, which includes products like NEXICLON XR, is expected to grow from US$ 1.4 billion in 2023 to US$ 3.2 billion by 2033, at a CAGR of 8.5%[3].
• Revenue Impact: The launch of NEXICLON XR and similar products contributes to the revenue growth in this market. For instance, the introduction of NEXICLON XR as the only once-daily clonidine extended-release tablet for hypertension treatment is expected to increase market share and revenue for Athena Bioscience LLC and its partners[1][3].

Competitive Landscape

The sustained release excipients market is competitive, with several major players such as Mylan NV, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Salix Pharmaceuticals, and Novartis AG. Companies are adopting strategies like mergers, acquisitions, collaborations for research and marketing, and the development of innovative products to enhance their market share. The exclusive rights to commercialize NEXICLON XR acquired by Athena Bioscience LLC from Tris Pharma Inc. in February 2021 is an example of such strategic moves[1].

Regulatory and Geopolitical Factors

• Regulatory Incentives: Regulatory incentives for advanced drug technologies and the rise of personalized medicine offer promising opportunities for growth. For example, the approval by the USFDA of Dr. Reddy’s Laboratories Ltd’s generic version of Fesoterodine Fumarate Extended-Release Tablets highlights the regulatory support for innovative drug delivery systems[1][3].
• Geopolitical Impact: Geopolitical factors such as trade policies and regulatory changes can impact the supply of raw materials and production. However, the focus on supply chain self-sufficiency and risk assessments, as seen during the COVID-19 pandemic, can also drive long-term stability and growth in the market[1].

Product-Specific Financial Impact

• Launch and Market Reception: The launch of NEXICLON XR in March 2022 marked a significant milestone in the treatment of hypertension. As the only once-daily clonidine extended-release tablet, it is expected to capture a substantial market share, contributing to the financial growth of Athena Bioscience LLC and its partners[1][3].
• Pricing and Competition: The pricing strategy for NEXICLON XR will be crucial in a competitive market. Given its unique once-daily dosing and the convenience it offers, the product is likely to command a premium price, contributing to higher revenue[4][5].

Challenges and Opportunities

• Challenges: The market faces challenges such as economic downturns, geopolitical disruptions, and regulatory changes. However, these challenges also present opportunities for companies to innovate and adapt, ensuring long-term growth[1][3].
• Opportunities: The growing focus on patient-centered healthcare and chronic disease management offers significant opportunities for sustained release formulations. Regulatory incentives and the rise of personalized medicine further support the market’s upward trajectory[1][3].

Key Takeaways

• Market Growth: The sustained release excipients market, including products like NEXICLON XR, is expected to grow significantly due to increasing demand for controlled and targeted drug delivery systems.
• Regional Dominance: North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR.
• Competitive Strategies: Companies are adopting various strategies to enhance their market share, including product launches, mergers, and acquisitions.
• Regulatory Support: Regulatory incentives and approvals are crucial for the growth of innovative drug delivery systems.

FAQs

1. What is NEXICLON XR used for? NEXICLON XR is used for the treatment of hypertension. It is a central alpha-adrenergic agonist that helps reduce blood pressure[4][5].

2. Who launched NEXICLON XR? NEXICLON XR was launched by Athena Bioscience LLC in March 2022, after acquiring exclusive rights to commercialize the product from Tris Pharma Inc. in February 2021[1][3].

3. What is the expected market growth for sustained release excipients? The sustained release excipients market is expected to grow at a CAGR of 7.1% to 8.5% during the forecast period from 2024 to 2033[1][3].

4. Which region is expected to grow the fastest in the sustained release excipients market? The Asia-Pacific region is expected to experience the highest CAGR during the forecast period due to expanding healthcare access and rising chronic disease prevalence[1][3].

5. What are the key factors driving the demand for sustained release formulations? The key factors include the increasing demand for controlled and targeted drug delivery systems, the growing prevalence of chronic diseases, and advancements in pharmaceutical technology[1][3].

Cited Sources

1. Mordor Intelligence: Sustained Release Excipients Market Size & Share Analysis
2. FDA: Nexiclon XR - accessdata.fda.gov
3. Market.US: Sustained Release Excipients Market Size, Share | CAGR Of 8.5%
4. DailyMed: NEXICLON XR- clonidine tablet, extended release - DailyMed
5. eMPR: NEXICLON XR Prescription & Dosage Information - eMPR.com