Midodrine hydrochloride - Generic Drug Details

What are the generic drug sources for midodrine hydrochloride and what is the scope of patent protection?

Midodrine hydrochloride is the generic ingredient in three branded drugs marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Rubicon, Thinq Pharm-cro Pvt, Xiromed, Zydus Lifesciences, Upsher Smith Labs, and Takeda Pharms Usa, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for midodrine hydrochloride. Twenty-eight suppliers are listed for this compound.

Summary for midodrine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	100
Patent Applications:	400
What excipients (inactive ingredients) are in midodrine hydrochloride?	midodrine hydrochloride excipients list
DailyMed Link:	midodrine hydrochloride at DailyMed

Recent Clinical Trials for midodrine hydrochloride

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

Sponsor	Phase
Noha Mansour	Phase 4
RenJi Hospital	N/A
Fuwai Yunnan Cardiovascular Hospital	N/A

See all midodrine hydrochloride clinical trials

Pharmacology for midodrine hydrochloride

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for midodrine hydrochloride

Adrenergic alpha-1 Receptor Agonists

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for midodrine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for midodrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207169-003	Oct 29, 2018	AB	RX	No	No
Endo Operations	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207169-002	Oct 29, 2018	AB	RX	No	No
Apotex	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	077746-001	Sep 12, 2006	AB	RX	No	No
Mankind Pharma	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	217271-003	Nov 1, 2023	AB	RX	No	No

Midodrine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Midodrine Hydrochloride

Introduction

Midodrine hydrochloride, a synthetic sympathomimetic amine, is primarily used to treat orthostatic hypotension and other related conditions. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current status, future projections, and the factors influencing its market.

Market Size and Growth Projections

The midodrine hydrochloride market has been valued at USD 744.93 million in 2023 and is expected to grow significantly, reaching USD 1,313.81 million by 2031. This growth is projected at a Compound Annual Growth Rate (CAGR) of 5.36% from 2024 to 2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the midodrine hydrochloride market:

Rising Incidence of Orthostatic Hypotension

The increasing prevalence of orthostatic hypotension, particularly among the elderly population, is a major driver. As the global population ages, the demand for treatments like midodrine hydrochloride is expected to rise[3].

Increased Awareness and Diagnosis

Growing awareness and improved diagnostic techniques for orthostatic hypotension are leading to more patients being identified and treated, thereby increasing the demand for midodrine hydrochloride[3].

Healthcare Infrastructure and Reimbursement

Improvements in healthcare infrastructure and favorable reimbursement policies are also contributing to the market's expansion. Governments and health insurance providers are increasingly supporting the use of midodrine hydrochloride, making it more accessible to patients[3].

Research and Development

Continuous research and development efforts aimed at broadening the therapeutic uses of midodrine hydrochloride are expected to accelerate market growth. New applications and improved formulations could further increase the drug's market share[3].

Market Segmentation

The midodrine hydrochloride market is segmented based on application, product form, and geographical regions.

Application

Midodrine hydrochloride is used in treating various conditions, including anaphylaxis, cardiac arrest, and primarily orthostatic hypotension. The therapeutic area of orthostatic hypotension is the most significant segment driving the market[3].

Product Form

The drug is available in oral tablets and oral solution forms. The oral tablet form is the most commonly used and preferred by patients due to its ease of administration[3].

Geographical Regions

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region, particularly China, is showing significant growth due to rapid advancements in the pharmaceutical industry and increasing healthcare needs[1][3].

Competitive Landscape

The competitive landscape for midodrine hydrochloride is characterized by several key players:

Generic Manufacturers

Since Shire Plc no longer manufactures, distributes, or markets midodrine hydrochloride, the market is dominated by generic pharmaceutical companies. These companies have been instrumental in keeping the drug available to patients despite regulatory challenges[2].

Regulatory Environment

The regulatory environment has been a critical factor in the market dynamics of midodrine hydrochloride. Despite initial approval in 1996 under an accelerated approval process, the FDA has required additional clinical trials to verify the drug's clinical efficacy. Shire and generic manufacturers have worked closely with the FDA to ensure the drug remains available[2][4].

Financial Trajectory

The financial trajectory of midodrine hydrochloride is influenced by several factors:

Revenue Growth

The market revenue is expected to grow from USD 744.93 million in 2023 to USD 1,313.81 million by 2031, indicating a robust financial outlook for the drug[3].

Cost and Pricing

The cost of midodrine hydrochloride is relatively stable, with generic versions available at competitive prices. This pricing strategy helps in maintaining market share and attracting more patients[3].

Investment in Research and Development

Companies are investing in research to explore new therapeutic uses for midodrine hydrochloride, which could lead to additional revenue streams and market expansion[3].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: The need for additional clinical trials to verify clinical efficacy has posed challenges. However, these trials also provide opportunities to strengthen the drug's market position[2][4].
• Supine Hypertension: Midodrine hydrochloride can cause supine hypertension, a significant side effect that requires careful management. This has led to the exploration of combination therapies to mitigate this risk[5].

Opportunities

• Expanding Therapeutic Uses: Ongoing research aimed at broadening the therapeutic applications of midodrine hydrochloride presents significant opportunities for market growth[3].
• Emerging Markets: The growing healthcare needs in emerging markets, particularly in the Asia-Pacific region, offer new avenues for expansion[1][3].

Key Takeaways

• The midodrine hydrochloride market is expected to grow significantly, driven by the rising incidence of orthostatic hypotension and favorable healthcare policies.
• The market is segmented by application, product form, and geographical regions, with the Asia-Pacific region showing rapid growth.
• Generic manufacturers play a crucial role in the market, and regulatory compliance is essential for maintaining market authorization.
• Continuous research and development efforts are key to expanding the drug's therapeutic uses and market share.

FAQs

What is midodrine hydrochloride used for?

Midodrine hydrochloride is primarily used to treat orthostatic hypotension, a condition characterized by a drop in blood pressure upon standing up. It is also used in treating other related conditions such as hypotension and certain nervous system diseases[1][4].

Who developed midodrine hydrochloride?

Midodrine hydrochloride was developed by Shire Plc, although Shire no longer manufactures, distributes, or markets the drug. It is now produced and distributed by generic pharmaceutical companies[2].

What are the potential side effects of midodrine hydrochloride?

One of the significant side effects of midodrine hydrochloride is supine hypertension, which can be managed by careful dosing and administration. The drug should not be administered close to bedtime to avoid this risk[4].

How is the market for midodrine hydrochloride expected to grow?

The market for midodrine hydrochloride is expected to grow at a CAGR of 5.36% from 2024 to 2031, reaching USD 1,313.81 million by 2031. This growth is driven by increasing demand due to an aging population and improved healthcare infrastructure[3].

What are the key drivers of the midodrine hydrochloride market?

The key drivers include the rising incidence of orthostatic hypotension, increased awareness and diagnosis, improvements in healthcare infrastructure, and favorable reimbursement policies. Ongoing research and development efforts also play a crucial role[3].

Sources

1. An In-depth Analysis of Midodrine Hydrochloride's R&D Progress - Synapse Patsnap
2. An Open Letter from Shire to Patients Prescribed ProAmatine - Shire
3. Midodrine Market Size, Trends and Projections - Market Research Intellect
4. Midodrine Monograph for Professionals - Drugs.com
5. Pyridostigmine Treatment Trial in Neurogenic Orthostatic Hypotension - JAMA Network