ORPHENADRINE CITRATE - Generic Drug Details

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

Orphenadrine citrate is the generic ingredient in two branded drugs marketed by Pai Holdings Pharm, Hikma, Rising, Sagent Pharms, Watson Labs, Bausch, Ascot, Bayshore Pharms Llc, Lupin, Sandoz, and Stevens J, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for orphenadrine citrate. Twenty suppliers are listed for this compound.

Summary for ORPHENADRINE CITRATE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	15
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	81
Patent Applications:	1,556
Drug Prices:	Drug price trends for ORPHENADRINE CITRATE
What excipients (inactive ingredients) are in ORPHENADRINE CITRATE?	ORPHENADRINE CITRATE excipients list
DailyMed Link:	ORPHENADRINE CITRATE at DailyMed

See drug prices for ORPHENADRINE CITRATE

Pharmacology for ORPHENADRINE CITRATE

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

US Patents and Regulatory Information for ORPHENADRINE CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	084303-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Stevens J	ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040368-001	Jun 23, 2000		DISCN	No	No
Sagent Pharms	ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	090585-001	Aug 30, 2011	AP	RX	No	No
Sandoz	ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	085046-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	ORPHENADRINE CITRATE	orphenadrine citrate	INJECTABLE;INJECTION	084779-001	Mar 15, 1982	AP	RX	No	No

ORPHENADRINE CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Orphenadrine Citrate

Introduction to Orphenadrine Citrate

Orphenadrine citrate is a medication used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. It is the citrate salt of orphenadrine, characterized by its white, crystalline powder form and bitter taste[2].

Market Size and Growth Projections

The Orphenadrine Citrate market is poised for significant growth over the forecast period from 2023 to 2031. The market is expected to grow from a valuation of USD 24.57 billion in 2024 to USD 52.51 billion by 2031, indicating a compound annual growth rate (CAGR) of 11.46%[3].

Key Drivers of Market Growth

Increasing Prevalence of Musculoskeletal Disorders

The rising incidence of chronic pain conditions and musculoskeletal disorders is a major driver of the Orphenadrine Citrate market. As the population ages, the demand for effective medications to alleviate pain associated with muscle spasms and tension is escalating[3].

Non-Opioid Pain Management Solutions

The trend towards non-opioid pain management solutions is gaining momentum, driven by the need to minimize the risks associated with opioid use. This shift is expected to bolster the market for Orphenadrine Citrate as healthcare professionals seek safer alternatives for patients[3].

Advancements in Pharmaceutical Formulations

Ongoing research and development efforts are leading to improved formulations and potential new indications for Orphenadrine Citrate. These advancements are broadening the application scope of the drug, contributing to its market growth[3].

Rising Healthcare Expenditure

Increasing healthcare expenditure and greater access to healthcare services in emerging markets are anticipated to contribute significantly to the market growth. This will ensure wider availability and adoption of Orphenadrine Citrate in pain management protocols[3].

Market Segmentation

The Orphenadrine Citrate market is segmented based on type (above 95%, above 96%), application (pharmaceutical, chemical, others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Type Segmentation

The market is categorized into different purity levels of Orphenadrine Citrate, such as above 95% and above 96%. These segments are crucial for understanding the quality and pricing dynamics within the market[1].

Application Segmentation

Orphenadrine Citrate is used in various applications, including pharmaceutical, chemical, and others. The pharmaceutical sector is the primary driver, given the drug's use in treating musculoskeletal conditions[1].

Geographical Segmentation

The market is analyzed across several geographical regions. Asia-Pacific is a rapidly growing region, driven by countries such as China, Japan, India, and South Korea. Europe and North America also represent significant markets due to their mature healthcare infrastructures and high demand for pain management solutions[3].

Competitive Landscape

The Orphenadrine Citrate market is characterized by a competitive landscape involving several key players. Companies such as Struchem, Ningbo Inno Pharmchem, Aceto, TNJ Chemical, and Finetech Industry Limited are prominent in the market. These companies are engaged in mergers and acquisitions to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness[3].

Market Concentration and Competition

The market concentration rate is moderate, with the top 5 and 10 largest players holding a significant share of the revenue. This indicates a balanced competitive environment where both established and emerging players have opportunities to grow[5].

Challenges and Restraints

Despite the positive growth prospects, the Orphenadrine Citrate market faces several challenges:

Safety Concerns

Orphenadrine citrate has several contraindications, including glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy, and myasthenia gravis. It also has potential side effects such as dryness of the mouth, tachycardia, and urinary retention, which can impact its adoption[2].

Regulatory Scrutiny

The safety of continuous long-term therapy with Orphenadrine Citrate has not been established, necessitating periodic monitoring of blood, urine, and liver function values. This regulatory scrutiny can affect the market's growth trajectory[2].

Regional Market Analysis

Asia-Pacific

This region is driven by a large population, rising disposable income, and increasing urbanization. Countries like China, Japan, India, and South Korea are key contributors to the growth in this region[3].

Europe

Europe is characterized by a mature market with well-established infrastructure and consumer preferences. Countries such as the United Kingdom, Germany, France, and Italy are significant players in the European market[3].

Latin America and Middle-East and Africa

These regions present both opportunities and challenges. Economic fluctuations and political instability in some countries can impact market dynamics, but there is also promising growth potential driven by urbanization and a young population[3].

Financial Performance and Projections

The financial performance of the Orphenadrine Citrate market is robust, with significant revenue growth projected over the next several years. The market size is expected to more than double from USD 24.57 billion in 2024 to USD 52.51 billion by 2031, reflecting strong financial health and growth potential[3].

Key Takeaways

• The Orphenadrine Citrate market is expected to grow significantly, driven by the increasing prevalence of musculoskeletal disorders and the trend towards non-opioid pain management solutions.
• Advancements in pharmaceutical formulations and rising healthcare expenditure are key drivers of market growth.
• The market is segmented by type, application, and geographical regions, with Asia-Pacific and Europe being major contributors.
• The competitive landscape is characterized by key players engaging in mergers and acquisitions to drive growth.
• Despite growth prospects, the market faces challenges related to safety concerns and regulatory scrutiny.

Frequently Asked Questions (FAQs)

1. What is the current market size and projected growth of the Orphenadrine Citrate market?

The Orphenadrine Citrate market is valued at USD 24.57 billion in 2024 and is expected to reach USD 52.51 billion by 2031, with a CAGR of 11.46%[3].

2. What are the primary drivers of the Orphenadrine Citrate market growth?

The primary drivers include the increasing prevalence of musculoskeletal disorders, the trend towards non-opioid pain management solutions, advancements in pharmaceutical formulations, and rising healthcare expenditure[3].

3. Who are the key players in the Orphenadrine Citrate market?

Key players include Struchem, Ningbo Inno Pharmchem, Aceto, TNJ Chemical, and Finetech Industry Limited[3].

4. What are the major geographical regions contributing to the Orphenadrine Citrate market growth?

The major regions include Asia-Pacific, Europe, North America, Latin America, and the Middle-East and Africa[3].

5. What are the potential challenges facing the Orphenadrine Citrate market?

The market faces challenges related to safety concerns, regulatory scrutiny, and potential side effects of the medication[2].

Cited Sources:

1. Market Research Intellect: Orphenadrine Citrate Market Size, Scope And Forecast Report[1].
2. DailyMed: Orphenadrine Citrate Extended-Release Tablets[2].
3. OpenPR: Orphenadrine Citrate Market Size, Share and Forecast By Key Players[3].
4. NPS MedicineWise: Norgesic Tablets[4].
5. MarketPublishers: Global Orphenadrine Citrate Market Research Report 2024[5].