CLONIDINE HYDROCHLORIDE - Generic Drug Details

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

Clonidine hydrochloride is the generic ingredient in six branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Tris Pharma Inc, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Dr Reddys Labs Sa, Endo Operations, Jubilant Generics, Novast Labs, Somerset Theraps Llc, Xiamen Lp Pharm Co, Concordia Pharms Inc, Boehringer Ingelheim, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Impax Labs, Interpharm, Par Pharm, Prinston Inc, Rising, Sun Pharm Inds Inc, Teva, Trupharma, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-eight NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clonidine hydrochloride has twenty-one patent family members in fourteen countries.

There are thirteen drug master file entries for clonidine hydrochloride. Forty-five suppliers are listed for this compound.

Summary for CLONIDINE HYDROCHLORIDE

International Patents:	21
US Patents:	2
Tradenames:	6
Applicants:	36
NDAs:	58
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	378
Patent Applications:	2,979
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLONIDINE HYDROCHLORIDE
What excipients (inactive ingredients) are in CLONIDINE HYDROCHLORIDE?	CLONIDINE HYDROCHLORIDE excipients list
DailyMed Link:	CLONIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CLONIDINE HYDROCHLORIDE

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

Sponsor	Phase
Universidad Simón Bolívar	Phase 3
National Cancer Institute, Egypt	N/A
Sollis Therapeutics, Inc.	Phase 3

See all CLONIDINE HYDROCHLORIDE clinical trials

Pharmacology for CLONIDINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for CLONIDINE HYDROCHLORIDE

C02AC	Imidazoline receptor agonists
C02A	ANTIADRENERGIC AGENTS, CENTRALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

N02CX	Other antimigraine preparations
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for CLONIDINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KAPVAY	Extended-release Tablets	clonidine hydrochloride	0.1 mg and 0.2 mg	022331	1	2011-03-04

US Patents and Regulatory Information for CLONIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202792-001	May 15, 2015		DISCN	No	No
Watson Labs	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070963-001	Jul 8, 1986		DISCN	No	No
Sun Pharm Inds Inc	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	090329-001	Jul 3, 2014		DISCN	No	No
Prinston Inc	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	077901-001	Mar 9, 2007	AB	RX	No	No
Rising	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070317-003	Jun 9, 1987		DISCN	No	No
Tris Pharma Inc	ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645-001	May 24, 2024		RX	Yes	Yes			Y
Fresenius Kabi Usa	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200673-002	Jul 8, 2011	AP	RX	No	No

Expired US Patents for CLONIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-001	Approved Prior to Jan 1, 1982
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-001	Sep 30, 2009
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-003	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-002	Approved Prior to Jan 1, 1982
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010
Concordia Pharms Inc	JENLOGA	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-002	May 25, 2010

International Patents for CLONIDINE HYDROCHLORIDE

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

CLONIDINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Clonidine Hydrochloride

Introduction

Clonidine hydrochloride, an α-2 adrenergic receptor agonist, has been a significant player in the pharmaceutical market, particularly in the treatment of hypertension and other related conditions. This article delves into the market dynamics and financial trajectory of clonidine hydrochloride, highlighting its current status, future projections, and the factors influencing its growth.

Market Size and Growth Projections

The global clonidine hydrochloride market has experienced rapid and substantial growth in recent years. Reports indicate that this trend is expected to continue, with significant expansion projected from 2023 to 2031[4,.

The market size is categorized based on type (0.1mg, 0.2mg, 0.3mg, and other) and application (hypertension, hypertensive emergencies, migraine, and other), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Market Segmentation

By Type

The market is segmented into various dosages, including 0.1mg, 0.2mg, 0.3mg, and other formulations. Each segment has its own market dynamics, influenced by factors such as patient needs, medical guidelines, and regional preferences[1][4].

By Application

Clonidine hydrochloride is used for several medical applications, including hypertension, hypertensive emergencies, migraine, and other off-label uses such as neonatal abstinence syndrome, analgesia, and sedation. The demand for each application varies, with hypertension being the primary driver of market growth[2][4].

By Geographical Region

The global market is divided into several geographical regions, each with its own growth trajectory. The Asia-Pacific region, for instance, is expected to show significant growth due to increasing healthcare spending and a large patient population[1][4].

Market Dynamics

Drivers

Several factors drive the growth of the clonidine hydrochloride market:

• Increasing Prevalence of Hypertension: The rising incidence of hypertension globally is a major driver, as clonidine hydrochloride is a commonly prescribed medication for this condition[4].
• Off-Label Uses: The drug's use in various off-label applications, such as neonatal abstinence syndrome and sedation, further boosts its demand[2].
• Advancements in Formulations: Improvements in compounding vehicles, such as the use of Ora-Blend and Oral-Mix, enhance the stability and efficacy of clonidine hydrochloride, making it more appealing to healthcare providers[2].

Restraints

Despite the growth, there are several restraints to consider:

• Side Effects: Common side effects like drowsiness, dryness of the mouth, and orthostatic symptoms can limit the use of maximally effective doses and impact patient compliance[5].
• Regulatory Challenges: Regulatory approvals and compliance can sometimes slow down market growth, especially when new formulations or uses are being considered[4].

Opportunities

The market presents several opportunities:

• Emerging Markets: Growing healthcare infrastructure and increasing healthcare spending in emerging markets offer significant growth opportunities[1][4].
• Research and Development: Continuous research into new applications and formulations can expand the market further[2].

Challenges

The market also faces several challenges:

• Competition: The presence of other antihypertensive medications and generic alternatives can pose a challenge to the market growth of clonidine hydrochloride[4].
• Stability Issues: Physical and chemical stability issues, particularly with certain compounding vehicles like simple syrup, need to be addressed to ensure patient safety and efficacy[2].

Financial Trajectory

The financial trajectory of the clonidine hydrochloride market is promising, with robust growth rates anticipated from 2023 to 2031. Here are some key financial insights:

Revenue Projections

The market is expected to see significant revenue growth, measured in USD million, across various segments. The detailed market study provides an outlook on the development of the market in terms of revenue throughout the prognosis period[1][4].

Market Value

The market value is projected to increase substantially, driven by the increasing demand for clonidine hydrochloride in treating hypertension and other conditions. The upward trend in market dynamics suggests strong growth rates in the foreseeable future[4].

Competitive Scenario

The competitive landscape of the clonidine hydrochloride market is characterized by several key players. These companies are involved in continuous research and development to improve formulations, expand applications, and enhance market penetration. The report provides detailed profiles of these companies, highlighting their strategies and market positions[4].

Regional Outlook

The regional outlook varies significantly:

• North America and Europe: These regions have established healthcare systems and high demand for clonidine hydrochloride, driven by a high prevalence of hypertension.
• Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare spending and a large patient population.
• South America and Middle-East and Africa: These regions also present growth opportunities, though at a slower pace compared to the Asia-Pacific region[1][4].

Stability and Formulation

The stability of clonidine hydrochloride is a critical factor in its market success. Recent studies have shown that formulations using Ora-Blend and Oral-Mix are more stable and effective compared to simple syrup, which can lead to physical instabilities and poor content uniformity[2].

Clinical Efficacy

Clonidine hydrochloride has been shown to be clinically effective in reducing blood pressure. Studies have demonstrated a statistically significant reduction in average mean blood pressure when used alone or in combination with other antihypertensive agents[5].

Conclusion

The clonidine hydrochloride market is poised for significant growth, driven by increasing demand for hypertension treatment, off-label uses, and advancements in formulations. While side effects and regulatory challenges exist, the overall financial trajectory indicates robust growth rates and substantial market expansion from 2023 to 2031.

Key Takeaways

• The global clonidine hydrochloride market is expected to experience significant growth from 2023 to 2031.
• The market is segmented by type, application, and geographical region.
• Drivers include the increasing prevalence of hypertension and advancements in formulations.
• Restraints include side effects and regulatory challenges.
• Opportunities lie in emerging markets and research into new applications.
• The financial trajectory indicates strong revenue growth and market value increase.

FAQs

Q: What are the primary applications of clonidine hydrochloride? A: The primary applications include hypertension, hypertensive emergencies, and migraine, with off-label uses in conditions such as neonatal abstinence syndrome, analgesia, and sedation.

Q: Which regions are expected to show the most significant growth in the clonidine hydrochloride market? A: The Asia-Pacific region is expected to show rapid growth due to increasing healthcare spending and a large patient population.

Q: What are the common side effects of clonidine hydrochloride? A: Common side effects include drowsiness, dryness of the mouth, and symptoms related to orthostasis.

Q: Why is the choice of compounding vehicle important for clonidine hydrochloride? A: The choice of vehicle is crucial to avoid physical and chemical instabilities, with Ora-Blend and Oral-Mix being preferred over simple syrup.

Q: What is the expected market value of the clonidine hydrochloride market by 2031? A: The market is expected to see significant revenue growth, though exact figures vary by report; however, all indicate substantial expansion.

Sources

1. Market Research Intellect - Global Clonidine Hydrochloride Market Size, Scope And Forecast Report
2. PLOS ONE - Stability evaluation of compounded clonidine hydrochloride oral liquids
3. P Market Research - Worldwide Clonidine Hydrochloride Market Research 2024 by Type, Application, Participants, and Countries Forecast to 2030
4. Market Research Intellect - Global Clonidine Hydrochloride Market Size, Trends and Projections
5. JAMA Network - Antihypertensive Effect of Clonidine: Its Use Alone and in Combination with Hydrochlorothiazide