CLONIDINE - Generic Drug Details

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

Clonidine is the generic ingredient in eleven branded drugs marketed by Tris Pharma Inc, Lavipharm, Actavis Labs Ut Inc, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Athena, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, 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 sixty-five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are twenty-two drug master file entries for clonidine. Eight suppliers are listed for this compound.

Summary for CLONIDINE

International Patents:	21
US Patents:	4
Tradenames:	11
Applicants:	41
NDAs:	65
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	378
Patent Applications:	6,340
Drug Prices:	Drug price trends for CLONIDINE
Drug Sales Revenues:	Drug sales revenues for CLONIDINE
What excipients (inactive ingredients) are in CLONIDINE?	CLONIDINE excipients list
DailyMed Link:	CLONIDINE at DailyMed

See drug prices for CLONIDINE

See drug sales revenues for CLONIDINE

Recent Clinical Trials for CLONIDINE

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 clinical trials

Pharmacology for CLONIDINE

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

Medical Subject Heading (MeSH) Categories for CLONIDINE

Adrenergic alpha-2 Receptor Agonists

Analgesics

Antihypertensive Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for CLONIDINE

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

US Patents and Regulatory Information for CLONIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Technologies	CLONIDINE	clonidine	SYSTEM;TRANSDERMAL	076166-002	Jul 16, 2010	AB	RX	No	No
Unichem	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	078895-003	Aug 26, 2009	AB	RX	No	Yes
Sun Pharm Inds Inc	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	090329-001	Jul 3, 2014		DISCN	No	No
Chartwell Molecules	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	071785-003	Apr 5, 1988	AB	RX	No	No
Am Therap	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	070882-001	Jul 8, 1986		DISCN	No	No
Unichem	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET;ORAL	078895-001	Aug 26, 2009	AB	RX	No	No

Expired US Patents for CLONIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	4,559,222
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	4,201,211
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	4,559,222
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	4,201,211
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	3,454,701
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	4,559,222

International Patents for CLONIDINE

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

CLONIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clonidine

Introduction to Clonidine

Clonidine, a medication primarily used to treat hypertension, hypertensive emergencies, and other conditions such as migraine and glaucoma, has been a significant player in the pharmaceutical market. Here, we delve into the market dynamics and financial trajectory of clonidine, exploring its current state, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The clonidine market has experienced substantial growth in recent years and is projected to continue this trend. According to market research reports, the clonidine hydrochloride market is expected to see significant expansion from 2023 to 2031, driven by increasing demand for hypertension treatments and other applications[1][3].

• Forecast Period: The market is forecasted to grow significantly during the period from 2024 to 2031, with a robust growth rate anticipated.
• Market Segments: The market is segmented by type (0.1mg, 0.2mg, 0.3mg, and other), application (hypertension, hypertensive emergencies, migraine, and other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][3].

Key Drivers of Market Growth

Several factors are driving the growth of the clonidine market:

• Increasing Prevalence of Hypertension: The rising incidence of hypertension globally is a major driver, as clonidine is a commonly prescribed medication for this condition.
• Expanding Applications: Clonidine's use in treating migraines, glaucoma, and other conditions further broadens its market potential[3].
• Geographical Expansion: Growth in emerging markets, particularly in the Asia-Pacific region, is expected to contribute significantly to the market's expansion[1].

Market Restraints and Challenges

Despite the positive growth trajectory, the clonidine market faces several challenges:

• Generic Competition: The availability of generic clonidine, which is significantly cheaper, can reduce the market share of branded products. For instance, generic clonidine is 98% cheaper than lofexidine, another medication used for similar purposes[2].
• Regulatory and Legal Issues: Pharmaceutical companies face regulatory hurdles and potential legal liabilities, which can deter investment in new drug development, including for addiction treatments where clonidine is sometimes used[2].

Competitive Landscape

The clonidine market is highly competitive, with several key players:

• Major Companies: Companies such as Boehringer Ingelheim, Teva Pharmaceuticals, Alembic Pharma, Daiichi Sankyo, and others are prominent in the market. These companies offer a range of clonidine products, including tablets and patches[1][3][4].
• Market Entry and Product Diversification: New entrants and existing players are diversifying their product portfolios to include different formulations of clonidine, such as circular and square patches, to cater to various market needs[3].

Financial Implications and ROI

The financial implications of the clonidine market are significant:

• Revenue Projections: The market is expected to generate substantial revenue, measured in USD million, across various segments during the forecast period[1][3].
• ROI on Drug Development: The return on investment (ROI) for clonidine development is influenced by factors such as product pricing, market penetration, and the extent of competition. Generic competition can significantly impact the ROI for branded products[2].

Impact of External Factors

External factors also play a crucial role in shaping the market dynamics of clonidine:

• Economic and Political Landscapes: National GDP, economic stability, and political environments in different regions can affect the market's growth. For example, economic downturns can reduce healthcare spending, impacting the demand for clonidine[1].
• Societal Stigma and Regulatory Environment: The societal stigma associated with addiction treatment, where clonidine is sometimes used, can influence pharmaceutical companies' willingness to invest in this area. Regulatory changes and additional exclusivity durations can also impact the market[2].

Market Opportunities and Challenges

The clonidine market presents several opportunities and challenges:

• Opportunities: The potential for clonidine in treating substance use disorders, as seen with GLP-1RAs, offers new avenues for market expansion. However, this requires significant investment in Phase 3 trials and regulatory approvals[2].
• Challenges: The lack of investment in addiction medication research due to societal stigma and regulatory risks poses a significant challenge. The "problem of new uses" for existing drugs, such as Ozempic and Mounjaro, also presents a barrier to market growth in new indications[2].

Quotes from Industry Experts

"Pharmaceutical companies are understandably reluctant to develop compounds specifically for drug addiction, if other medical uses for the compounds are possible." - This sentiment highlights the industry's cautious approach to addiction treatment due to societal stigma and market dynamics[2].

Illustrative Statistics

• Market Size: The clonidine hydrochloride market is projected to experience significant growth, with the global market size expected to increase substantially by 2031[1].
• Generic Competition: Generic clonidine is 98% cheaper than lofexidine, illustrating the competitive pressure from generic alternatives[2].
• Venture Investment: Addiction medication receives only 0.4% of the venture investment that cancer does, despite addiction causing more deaths, highlighting the underinvestment in this area[2].

Key Takeaways

• Growth Projections: The clonidine market is expected to grow significantly from 2023 to 2031.
• Market Segments: The market is segmented by type, application, and geographical regions.
• Drivers and Restraints: Increasing prevalence of hypertension and expanding applications drive growth, while generic competition and regulatory challenges pose restraints.
• Competitive Landscape: The market is highly competitive with several key players.
• Financial Implications: ROI is influenced by product pricing, market penetration, and competition.

FAQs

1. What are the primary applications of clonidine?

   • Clonidine is primarily used to treat hypertension, hypertensive emergencies, migraines, and glaucoma.

2. Which regions are expected to drive the growth of the clonidine market?

   • The Asia-Pacific region, along with North America and Europe, is expected to contribute significantly to the market's growth.

3. How does generic competition affect the clonidine market?

   • Generic clonidine, being significantly cheaper, reduces the market share of branded products and impacts the ROI for pharmaceutical companies.

4. What external factors influence the clonidine market?

   • Economic and political landscapes, societal stigma, and regulatory environments all play crucial roles in shaping the market dynamics.

5. Why is there limited investment in addiction medication research?

   • The limited investment is due to societal stigma, regulatory risks, and the preference for other medical uses of compounds that could treat addiction.

Sources

1. Market Research Intellect. Global Clonidine Hydrochloride Market Size, Trends and Projections.
2. Institute for Progress. An Innovation Agenda for Addiction.
3. Market Research Intellect. Clonidine Market Size, Share, Outlook, Analysis and Forecast.
4. Valuates Reports. Global Clonidine Market Research Report 2024.