LONITEN Drug Patent Profile

Which patents cover Loniten, and what generic alternatives are available?

Loniten is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in LONITEN is minoxidil. There are eight drug master file entries for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Loniten

A generic version of LONITEN was approved as minoxidil by WATSON LABS on March 3^rd, 1987.

Summary for LONITEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	1
Patent Applications:	6,042
DailyMed Link:	LONITEN at DailyMed

Recent Clinical Trials for LONITEN

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Early Phase 1

See all LONITEN clinical trials

US Patents and Regulatory Information for LONITEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for LONITEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-001	Approved Prior to Jan 1, 1982	3,461,461
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-003	Approved Prior to Jan 1, 1982	3,461,461

International Patents for LONITEN

See the table below for patents covering LONITEN around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1695959	6-AMINO-1,2-DIHYDRO-1-HYDROXY-2- IMINO-4-PHENOXY-PYRIMIDINE
United Kingdom	1167735
France	6032
Germany	1695940
United Kingdom	1167736

LONITEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: LONITEN

Introduction

LONITEN, a brand name for the drug minoxidil, is used primarily to treat high blood pressure and, in its topical form, to promote hair growth. Understanding the market dynamics and financial trajectory of LONITEN involves analyzing various factors, including competition, regulatory environment, and market demand.

Market Competition in the Generic Drug Industry

The generic drug industry, where LONITEN's generic version operates, is highly competitive. Studies have shown that generic drug prices decrease as the number of competitors increases. For instance, generic drug prices remain above long-run marginal costs until there are at least eight competitors in the market[1][4].

Entry of Competitors

In markets with greater expected rents, more firms enter, and they enter more quickly. This is evident in the generic drug industry, where the size and time paths of generic revenues, profits, and the number of firms are significantly influenced by the expected market size[1][4].

Price Dynamics

As more competitors enter the market, prices for generic drugs like minoxidil tend to fall. The initial generic monopolist typically charges prices 35% to 50% above long-run marginal costs. However, these prices decline as the number of producers increases and approach long-run marginal cost when there are eight or more competitors[1][4].

Regulatory Environment

FDA Policies

Changes in FDA policies can significantly impact the generic drug market. For example, increased scrutiny of generic drug applications can raise the cost of obtaining approval, potentially reducing the number of entrants and affecting prices. Conversely, policies that allow for simultaneous approval of multiple generic entrants can lead to earlier competition and lower prices, although this might reduce expected rents and discourage future entrants[1].

Financial Performance of Similar Drugs

To gauge the financial trajectory of LONITEN, it is useful to look at the financial performance of similar drugs or companies in the pharmaceutical sector.

Pharming Group Example

Pharming Group, a company that produces and markets pharmaceuticals, reported significant revenue growth in recent years. For instance, their total revenues increased by 19% to $245.3 million in 2023, driven by strong sales of their drug RUCONEST® and the launch of Joenja® (leniolisib)[5].

• Revenue Growth: Companies like Pharming Group show that successful drugs can drive substantial revenue growth. For LONITEN, similar growth would depend on its market position, competition, and demand.
• Cost and Profit Margins: The cost of sales and gross profit margins are crucial. For Pharming Group, gross profit increased by 34% to $66.1 million in the second quarter of 2024, mainly due to revenue increases[2].

Market Demand and Trends

Personalized Medicine

The trend towards personalized medicine can impact the demand for drugs like LONITEN. For example, the compounded topical drugs market, which includes customized treatments, is growing due to high demand for individualized treatment and technological advancements[3].

Telemedicine and Online Pharmacies

The integration of telemedicine and online pharmacies has increased access to customized medicines, including those that might compete with or complement LONITEN. This trend is expected to continue, making such treatments more convenient and accessible[3].

Regional Market Analysis

Global Market

The global market for pharmaceuticals, including generic drugs like minoxidil, varies by region. For instance, the compounded topical drugs market in the USA is expected to grow at a CAGR of 4.5% through 2034, while China is projected to witness a CAGR of 6.1% during the same period[3].

Key Takeaways

• Competition: The number of competitors significantly affects the price and profitability of generic drugs like LONITEN.
• Regulatory Environment: FDA policies can influence the cost of entry and the number of competitors in the market.
• Financial Performance: Successful pharmaceuticals can drive substantial revenue growth, but this depends on market position, competition, and demand.
• Market Trends: Trends towards personalized medicine and the use of telemedicine and online pharmacies can impact demand and accessibility.

FAQs

Q: How does the number of competitors affect the price of generic drugs like LONITEN?

A: The price of generic drugs like LONITEN decreases as the number of competitors increases. Prices remain above long-run marginal costs until there are at least eight competitors in the market[1][4].

Q: What impact do FDA policies have on the generic drug market?

A: FDA policies, such as increased scrutiny of applications or simultaneous approval of multiple generic entrants, can affect the cost of entry, the number of competitors, and ultimately the prices of generic drugs[1].

Q: How is the trend towards personalized medicine affecting the pharmaceutical market?

A: The trend towards personalized medicine is driving demand for customized treatments, including compounded topical drugs, which can impact the market for drugs like LONITEN by offering alternative or complementary treatment options[3].

Q: What role do telemedicine and online pharmacies play in the pharmaceutical market?

A: Telemedicine and online pharmacies are increasing access to customized medicines, making treatments more convenient and accessible, which can influence the demand for drugs like LONITEN[3].

Q: How does regional market analysis impact the financial trajectory of a drug like LONITEN?

A: Regional market analysis shows varying growth rates and market sizes, which can affect the financial trajectory of a drug. For example, the USA and China have different growth projections, which could influence the global strategy for LONITEN[3].

Sources

1. Federal Trade Commission - Generic Drug Industry Dynamics[1]
2. Biospace - Pharming Group reports second quarter and first half 2024 financial results and provides business update[2]
3. Future Market Insights - Compounded Topical Drugs Market Sees Significant Growth[3]
4. SSRN - Generic Drug Industry Dynamics[4]
5. GlobeNewswire - Pharming Group reports fourth quarter and full year 2023 financial results[5]