METHYLDOPA - Generic Drug Details

What are the generic sources for methyldopa and what is the scope of patent protection?

Methyldopa is the generic ingredient in three branded drugs marketed by Merck, Accord Hlthcare, Chartwell Rx, Duramed Pharms Barr, Halsey, Heritage Pharma, Parke Davis, Pliva, Purepac Pharm, Rising, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in fifty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for methyldopa. Two suppliers are listed for this compound.

Summary for METHYLDOPA

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	57
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	19
Patent Applications:	5,656
Drug Prices:	Drug price trends for METHYLDOPA
What excipients (inactive ingredients) are in METHYLDOPA?	METHYLDOPA excipients list
DailyMed Link:	METHYLDOPA at DailyMed

See drug prices for METHYLDOPA

Recent Clinical Trials for METHYLDOPA

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

Sponsor	Phase
Cairo University	Phase 4
Federal University of Paraíba	Phase 4
Assiut University	Phase 2

See all METHYLDOPA clinical trials

Pharmacology for METHYLDOPA

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

Medical Subject Heading (MeSH) Categories for METHYLDOPA

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

Sympatholytics

US Patents and Regulatory Information for METHYLDOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	METHYLDOPATE HYDROCHLORIDE	methyldopate hydrochloride	INJECTABLE;INJECTION	070849-001	Jun 19, 1987		DISCN	No	No
Watson Labs	METHYLDOPA	methyldopa	TABLET;ORAL	070703-001	Jun 6, 1986		DISCN	No	No
Merck	ALDOMET	methyldopate hydrochloride	INJECTABLE;INJECTION	013401-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Purepac Pharm	METHYLDOPA	methyldopa	TABLET;ORAL	070749-001	Feb 7, 1986		DISCN	No	No

Expired US Patents for METHYLDOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	ALDOMET	methyldopa	SUSPENSION;ORAL	018389-001	Approved Prior to Jan 1, 1982	4,404,193

METHYLDOPA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methyldopa

Introduction to Methyldopa

Methyldopa, also known as alpha-methyldopa, is a medication primarily used to treat hypertension (high blood pressure) and, in some cases, Parkinson's disease and hepatic coma. The drug works by lowering certain chemicals in the blood, which helps to relax blood vessels and reduce blood pressure.

Current Market Size and Growth

The global methyldopa market has been experiencing rapid growth in recent years. As of 2023, the market size was valued at $9.31 billion and is projected to grow to $10.24 billion in 2024, with a compound annual growth rate (CAGR) of 10.0%[1][2].

Forecasted Growth

By 2028, the market is expected to reach $15.14 billion, maintaining a CAGR of 10.3%. This robust growth is driven by several key factors:

• Improving Diagnostic Techniques: Advances in diagnostic methods are leading to earlier and more accurate detection of hypertension, increasing the demand for treatments like methyldopa.
• Public Health Campaigns: Expanded public health campaigns are raising awareness about hypertension and the importance of managing chronic diseases.
• Research Funding and Healthcare Infrastructure: Increased funding for healthcare research and the development of healthcare infrastructure are supporting the growth of the methyldopa market.
• Rising Hypertension Cases: The increasing prevalence of hypertension, driven by factors such as poor diet, lack of physical activity, obesity, and elevated stress levels, is a significant driver of the market[1][2].

Market Segmentation

The methyldopa market is segmented by type, purity, and application:

• By Type: The market is primarily segmented into oral and intravenous drip forms. Oral forms are significant due to their ease of administration and widespread use[2][4].
• By Purity: The market is segmented by purity levels, including =98% and =99% purity, which cater to different medical needs and regulatory standards[2].
• By Application: Methyldopa is used in treating hypertension, Parkinsonism, and hepatic coma. Hypertension treatment is the dominant application due to the high prevalence of the condition[2][4].

Regional Analysis

The methyldopa market is analyzed across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. The Asia-Pacific region is expected to be a significant growth area due to its large population, increasing healthcare expenditure, and growing awareness about chronic diseases[1][2].

Drivers of the Market

Several factors are driving the growth of the methyldopa market:

• Increasing Awareness and Public Health Campaigns: Public health campaigns and increasing awareness about hypertension are driving the demand for effective treatments like methyldopa.
• Growing Preference for Generic Drugs: Generic versions of methyldopa are cost-effective and offer equivalent quality, performance, and safety, making them highly preferred. In the U.S., generics constitute approximately 90% of the prescription drug market volume[1][2].
• Rising Healthcare Expenditure: Global healthcare expenditure is increasing due to aging populations, higher incidence of chronic diseases, and greater demand for healthcare services and medications. For example, in the UK, healthcare spending rose to $363.44 billion in 2021, with an average expenditure of $5422 per person[1][2].

Trends and Innovations

The methyldopa market is influenced by several trends and innovations:

• Advancements in Drug Delivery Systems: Improvements in drug delivery systems are enhancing the efficacy and patient compliance of methyldopa treatments.
• Biopharmaceutical Innovations: Innovations in biopharmaceuticals are leading to more effective and targeted treatments.
• Digital Health Solutions and Artificial Intelligence: The integration of digital health solutions and the application of artificial intelligence in healthcare are improving diagnosis, treatment, and patient management[1][2].

Challenges and Restraints

Despite the growth potential, the methyldopa market faces some challenges:

• High Inflation and Economic Uncertainties: Economic factors such as high inflation and the impact of global events like the Ukraine-Russia war can affect market stability.
• COVID-19 Impact: The COVID-19 pandemic has had a mixed impact on the market, with some disruptions in supply chains but also increased focus on healthcare infrastructure and research[2].

Key Statistics and Examples

• Prevalence of Hypertension: For instance, the Heart Foundation reported that about 23% of adults in Australia have hypertension, with a higher prevalence among men (25%) than women (22%)[1].
• Healthcare Expenditure: In the UK, healthcare spending rose to $363.44 billion in 2021, a 9.7% absolute increase from 2020, indicating a significant increase in healthcare funding[2].

Expert Insights

"Methyldopa effectively treats hypertension by lowering specific chemicals in the blood, promoting blood vessel relaxation and reducing blood pressure," notes a report from The Business Research Company. This underscores the drug's critical role in managing a prevalent chronic condition[1].

Market Outlook

The methyldopa market is poised for substantial growth driven by improving diagnostic techniques, increasing public health campaigns, and rising healthcare expenditure. The integration of digital health solutions and advancements in drug delivery systems will further enhance the market's trajectory.

Key Takeaways

• The global methyldopa market is expected to grow from $9.31 billion in 2023 to $15.14 billion by 2028.
• Key drivers include increasing awareness about hypertension, growing preference for generic drugs, and rising healthcare expenditure.
• The market is segmented by type (oral and intravenous drip), purity, and application (hypertension, Parkinsonism, and hepatic coma).
• Regional growth is significant in the Asia-Pacific region due to its large population and increasing healthcare expenditure.
• Trends include advancements in drug delivery systems, biopharmaceutical innovations, and the integration of digital health solutions.

FAQs

Q: What is the current market size of the methyldopa market? A: As of 2023, the global methyldopa market size was valued at $9.31 billion[1].

Q: What is the projected growth rate of the methyldopa market? A: The market is expected to grow at a CAGR of 10.3% from 2023 to 2028[1][2].

Q: Which regions are expected to dominate the methyldopa market? A: The Asia-Pacific region is expected to be a significant growth area due to its large population and increasing healthcare expenditure[1][2].

Q: What are the main drivers of the methyldopa market? A: Key drivers include increasing awareness about hypertension, growing preference for generic drugs, and rising healthcare expenditure[1][2].

Q: How does the integration of digital health solutions impact the methyldopa market? A: The integration of digital health solutions and the application of artificial intelligence in healthcare are improving diagnosis, treatment, and patient management, thus enhancing the market's growth[1][2].

Sources

1. Alpha (a) Methyldopa Global Market Report 2024 - GII Research
2. Alpha Methyldopa Market Report 2024 - The Business Research Company
3. a Methyldopa Market Report 2024 (Global Edition) - Cognitive Market Research
4. Global Methyldopa Market Size And Forecast - Market Research Intellect
5. Methyldopa Manufacturing Plant Report 2024: Setup & Cost - IMARC Group