PYRIMETHAMINE - Generic Drug Details

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

Pyrimethamine is the generic ingredient in three branded drugs marketed by Tilde Sciences, Alvogen, Aurobindo Pharma Ltd, Sanaluz, Teva Pharms, and Roche, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for pyrimethamine. Eight suppliers are listed for this compound.

Summary for PYRIMETHAMINE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	222
Patent Applications:	6,778
Drug Prices:	Drug price trends for PYRIMETHAMINE
What excipients (inactive ingredients) are in PYRIMETHAMINE?	PYRIMETHAMINE excipients list
DailyMed Link:	PYRIMETHAMINE at DailyMed

See drug prices for PYRIMETHAMINE

Recent Clinical Trials for PYRIMETHAMINE

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

Sponsor	Phase
Kamuzu University of Health Sciences	Phase 4
Malaria Consortium	Phase 3
Washington University School of Medicine	Early Phase 1

See all PYRIMETHAMINE clinical trials

Pharmacology for PYRIMETHAMINE

Drug Class	Dihydrofolate Reductase Inhibitor Antimalarial
Mechanism of Action	Dihydrofolate Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for PYRIMETHAMINE

Antimalarials

Antiprotozoal Agents

Folic Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PYRIMETHAMINE

P01BD	Diaminopyrimidines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for PYRIMETHAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanaluz	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	207127-001	Feb 28, 2020	AB	RX	No	No
Teva Pharms	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	215506-001	Aug 13, 2021	AB	RX	No	No
Tilde Sciences	DARAPRIM	pyrimethamine	TABLET;ORAL	008578-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Aurobindo Pharma Ltd	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	216983-001	Oct 25, 2022	AB	RX	No	No
Roche	FANSIDAR	pyrimethamine; sulfadoxine	TABLET;ORAL	018557-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alvogen	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	211271-001	Jul 27, 2021	AB	RX	No	No

PYRIMETHAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pyrimethamine

Market Overview

Pyrimethamine, a crucial antiparasitic medication, is listed on the World Health Organization’s (WHO) list of essential medicines. It is primarily used to treat and prevent protozoan infections such as malaria and toxoplasmosis, particularly in immunocompromised patients, including those with HIV/AIDS[1][4].

Market Size and Growth

The global pyrimethamine market is projected to experience significant growth over the coming years. As of 2021, the market was valued at approximately USD 1.51 billion and is expected to reach USD 2.32 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 5.50% during the forecast period of 2022-2029[1].

Another report indicates that the market was valued at USD 1,106.8 million in 2021 and is anticipated to reach USD 1,792.0 million by 2030, with a CAGR of 5.5% from 2021 to 2030[4].

Segmentation Analysis

The pyrimethamine market is segmented based on several key factors:

Indications

• The primary indications for pyrimethamine include malaria and toxoplasmosis, with other parasitic infections also being treated with this drug[1][4].

Route of Administration

• The oral route is the most common and convenient method of administration, with most products available in capsule and tablet forms[1].

End Users

• Hospitals, homecare, specialty clinics, and other healthcare settings are the main end users. Hospitals dominated the market with a significant share, driven by the need for treating serious parasitic infections[1][4].

Distribution Channels

• The distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies. Hospital pharmacies play a crucial role due to the immediate need for the medication in clinical settings[1].

Drivers of Market Growth

Several factors are driving the growth of the pyrimethamine market:

Increase in HIV Cases

• The rising number of HIV-positive individuals worldwide increases the demand for pyrimethamine, as it is used to prevent and treat toxoplasmosis and other opportunistic infections in these patients[1][4].

Rising Demand for Oral Drugs

• The convenience and effectiveness of oral drugs have boosted the market growth, as most pyrimethamine products are available in oral forms[1].

Increasing Drug Development and Research Activities

• Ongoing research and development activities aimed at improving the efficacy and safety of pyrimethamine formulations are expected to drive market growth[1].

Challenges and Restraints

Despite the growth drivers, the market faces several challenges:

High Cost

• The significant expenditure associated with pyrimethamine and its formulations can hamper market growth, especially in regions with limited healthcare budgets[1].

Side Effects

• The medication is associated with various side effects, including allergic reactions, blood disorders, and heart rhythm disorders, which can act as a restraining factor for market growth[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pyrimethamine market:

Short-Term Disruptions

• The pandemic led to delays in clinical trials and disruptions in healthcare infrastructure, which temporarily affected the market[1].

Long-Term Opportunities

• The increased focus on biotechnology and pharmaceuticals during the pandemic is expected to drive future growth in the market, particularly for essential medications like pyrimethamine[1].

Regional Analysis

The global pyrimethamine market is geographically diverse:

North America

• North America dominates the market due to the presence of key manufacturers, high research and development investments, and significant healthcare expenditure[1][4].

Asia-Pacific

• The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period, driven by government awareness programs and an increased prevalence of malaria and AIDS[1][4].

Competitive Landscape

The market is characterized by the presence of several key players:

Major Market Players

• Companies such as Vyera Pharmaceuticals, LLC, GlaxoSmithKline plc, Impax Laboratories, Inc., Pfizer, Inc., and others play significant roles in the market[4].

Innovative Strategies

• Companies like Imprimis Pharmaceuticals have introduced cost-effective formulations by leveraging compounding regulations to undercut high-priced generic drugs, thereby increasing market competition and accessibility[2].

Financial Trajectory

The financial trajectory of the pyrimethamine market is marked by steady growth:

Revenue Growth

• The market is expected to grow from USD 1.51 billion in 2021 to USD 2.32 billion by 2029, and from USD 1,106.8 million in 2021 to USD 1,792.0 million by 2030, indicating a robust financial outlook[1][4].

Profitability

• Despite the challenges, companies can achieve profitability by offering cost-effective formulations and leveraging compounding regulations, as seen with Imprimis Pharmaceuticals[2].

Key Takeaways

• The global pyrimethamine market is driven by the increasing number of HIV cases and the demand for oral antiparasitic drugs.
• The market faces challenges such as high costs and side effects but is expected to grow steadily.
• North America and the Asia-Pacific region are key markets, with the latter expected to grow at the fastest CAGR.
• Innovative strategies by companies like Imprimis Pharmaceuticals are enhancing market competition and accessibility.

FAQs

1. What is the current market size of the pyrimethamine market?

• The market was valued at approximately USD 1.51 billion in 2021 and USD 1,106.8 million in another report[1][4].

2. What is the expected CAGR of the pyrimethamine market?

• The market is expected to grow at a CAGR of 5.50% from 2022 to 2029 and 5.5% from 2021 to 2030[1][4].

3. Which region dominates the pyrimethamine market?

• North America currently dominates the market, but the Asia-Pacific region is expected to grow at the fastest rate[1][4].

4. What are the primary indications for pyrimethamine?

• The primary indications include malaria and toxoplasmosis[1][4].

5. How has the COVID-19 pandemic affected the pyrimethamine market?

• The pandemic caused short-term disruptions but is expected to drive long-term growth in the biotechnology and pharmaceutical sectors[1].

Citations

1. Data Bridge Market Research: Global Pyrimethamine Market – Industry Trends and Forecast to 2029.
2. Los Angeles Times: Drug pricing: That pill that went from $13.50 to $750 can now be had for $1.
3. Market Research Intellect: Pyrimethamine Tablets Market Size, Scope And Forecast Report.
4. Spherical Insights: Pyrimethamine Market Size, Trend during Forecast 2030.
5. Unitaid: Call for proposals: Intermittent Preventive Treatment in infants.