DROXIDOPA - Generic Drug Details

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

Droxidopa is the generic ingredient in two branded drugs marketed by Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, Lupin Pharms, Msn Pharms Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Pharms Usa Inc, Upsher Smith Labs, Zydus Pharms, and Lundbeck Na Ltd, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for droxidopa. Sixteen suppliers are listed for this compound.

Summary for DROXIDOPA

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	17
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	34
Patent Applications:	652
Drug Prices:	Drug price trends for DROXIDOPA
What excipients (inactive ingredients) are in DROXIDOPA?	DROXIDOPA excipients list
DailyMed Link:	DROXIDOPA at DailyMed

See drug prices for DROXIDOPA

Recent Clinical Trials for DROXIDOPA

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

Sponsor	Phase
Kessler Foundation	Phase 4
Loma Linda University	Phase 2
H. Lundbeck A/S	Phase 2

See all DROXIDOPA clinical trials

Pharmacology for DROXIDOPA

Physiological Effect

Increased Blood Pressure

Medical Subject Heading (MeSH) Categories for DROXIDOPA

Antiparkinson Agents

Anatomical Therapeutic Chemical (ATC) Classes for DROXIDOPA

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

US Patents and Regulatory Information for DROXIDOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	DROXIDOPA	droxidopa	CAPSULE;ORAL	214387-003	Feb 18, 2021	AB	RX	No	No
Aurobindo Pharma Ltd	DROXIDOPA	droxidopa	CAPSULE;ORAL	214387-002	Feb 18, 2021	AB	RX	No	No
Ajanta Pharma Ltd	DROXIDOPA	droxidopa	CAPSULE;ORAL	214391-001	Feb 18, 2021	AB	RX	No	No
Chartwell Rx	DROXIDOPA	droxidopa	CAPSULE;ORAL	214217-003	May 5, 2022		DISCN	No	No

DROXIDOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Droxidopa

Market Overview

Droxidopa, a medication used to treat symptomatic neurogenic orthostatic hypotension (nOH), is experiencing significant growth in the global pharmaceutical market. The drug is designed to increase the deficient supply of norepinephrine and dopamine in patients, particularly those with conditions such as dopamine beta-hydroxylase deficiency, non-diabetic autonomic neuropathy, and primary autonomic failure[1].

Market Size and Growth

The Droxidopa market is forecast to reach US$487.1 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 7.8% during the period from 2022 to 2027. This growth is driven by increasing cases of neurogenic orthostatic hypotension and other related conditions such as anemia, dizziness, dehydration, and syncope, especially in the Asia Pacific region[1].

Geographical Segmentation

The Asia Pacific region holds the largest share in the Droxidopa market, accounting for approximately 34% of the market in 2021. This dominance is attributed to the growing working class and the prevalence of symptomatic diseases in countries like China, India, Indonesia, and others. The region is expected to register a CAGR of 8.8% during the forecast period[1].

Formulation and Dosage

The market is segmented by formulation, with capsules being the dominant form, accounting for around 40% of the market share in 2021. Capsules are preferred due to their immediate entry into the bloodstream, providing quick relief to patients. The 300 mg dosage segment is also significant, accounting for approximately 38% of the market share, and is widely used to treat orthostatic dizziness and lightheadedness in adult patients[1].

Driving Factors

Several factors are driving the growth of the Droxidopa market:

• Increasing Prevalence of Neurogenic Orthostatic Hypotension: Conditions such as anemia, dehydration, and endocrine problems are on the rise, contributing to the growth of the market[1].
• Growing Working Class: The increasing working class, especially in developing countries, is leading to higher stress levels and longer working hours, which in turn increase the incidence of neurogenic orthostatic hypotension[1].
• Research and Development: Continuous research and development aimed at treating symptomatic neurogenic orthostatic hypotension are driving market growth[1].

Challenges

Despite the growth, the Droxidopa market faces several challenges:

• Adverse Effects: Droxidopa can cause side effects such as nausea, dizziness, headache, and hypertension. Severe side effects include supine hypertension, arrhythmias, congestive heart failure, and ischemic heart disease[5].
• Regulatory and Competitive Pressures: The loss of exclusivity for certain drugs, such as Northera (a brand of droxidopa), can lead to increased competition from generic versions[2].

Financial Performance

Companies involved in the production and distribution of Droxidopa are experiencing significant financial growth. For instance, Lundbeck, a major player in the pharmaceutical industry, reported exceptional growth in their strategic brands, including those related to neurogenic orthostatic hypotension. Their revenue from strategic brands grew by 31% in 2022, representing 67% of their total revenue[2].

Key Players

The Droxidopa market is dominated by several key players:

• H. Lundbeck AS: Known for their strategic brands and significant revenue growth.
• Novartis AG: A major pharmaceutical company with a strong presence in the orthostatic hypotension drugs market.
• Mylan NV: Another key player in the production and distribution of Droxidopa.
• Pfizer Inc.: A global pharmaceutical giant with a diverse portfolio including orthostatic hypotension treatments.
• Amneal Pharmaceuticals Inc.: A company that contributes to the market through its range of pharmaceutical products[3].

Regional Market Dynamics

The Asia Pacific region is expected to continue its strong growth due to the increasing prevalence of diseases such as anemia and the growing working class. In countries like India, the IT sector's expansion is contributing to higher stress levels and longer working hours, which in turn drive the demand for Droxidopa[1].

Distribution Channels

The distribution of Droxidopa is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant channel due to the need for immediate and reliable access to the medication for patients with severe symptoms[4].

End Users

The end users of Droxidopa include hospitals, clinics, and home care settings. Hospitals and clinics are primary users due to the need for monitored administration and adjustment of the medication to avoid adverse effects[4].

Dosage Strength

The dosage strength of Droxidopa varies, with the 300 mg dosage being the most commonly used. The dosage can be adjusted based on the patient's symptomatic response, with a maximum recommended total daily dose of 1800 mg[5].

Financial Assistance and Copay Programs

To alleviate the financial burden on patients, various copay assistance programs are available. For example, AmeriPharma Specialty Care offers financial aid and reduces copays, out-of-pocket expenses, and high deductibles, securing significant financial assistance for patients[5].

Key Takeaways

• The Droxidopa market is projected to reach US$487.1 million by 2027, growing at a CAGR of 7.8%.
• The Asia Pacific region is the largest market segment due to the growing working class and prevalence of related diseases.
• Capsules and the 300 mg dosage are the dominant forms and strengths, respectively.
• Increasing research and development, along with growing health conditions, drive market growth.
• Adverse effects and regulatory pressures are key challenges.
• Major players like Lundbeck, Novartis, and Pfizer contribute significantly to the market.

Frequently Asked Questions

What is the forecasted market size of Droxidopa by 2027?

The Droxidopa market is forecast to reach US$487.1 million by 2027[1].

What is the CAGR of the Droxidopa market from 2022 to 2027?

The Droxidopa market is expected to grow at a CAGR of 7.8% from 2022 to 2027[1].

Which region holds the largest share in the Droxidopa market?

The Asia Pacific region holds the largest share in the Droxidopa market, accounting for approximately 34% of the market in 2021[1].

What are the common side effects of Droxidopa?

Common side effects include nausea, dizziness, headache, and hypertension. Severe side effects can include supine hypertension, arrhythmias, congestive heart failure, and ischemic heart disease[5].

Which companies are the key players in the Droxidopa market?

Key players include H. Lundbeck AS, Novartis AG, Mylan NV, Pfizer Inc., and Amneal Pharmaceuticals Inc.[3].

Cited Sources:

1. IndustryARC: Droxidopa Market Size Report, 2022-2027.
2. Lundbeck Annual Report 2022: Financial Key Figures and Management Review.
3. Business Research Insights: Orthostatic Hypotension Drugs Market Size & Share [2032].
4. Market Research Future: Droxidopa Market Research Report.
5. AmeriPharma Specialty Care: Droxidopa Copay Assistance.