PRIMSOL Drug Patent Profile

When do Primsol patents expire, and when can generic versions of Primsol launch?

Primsol is a drug marketed by Pangea and is included in two NDAs.

The generic ingredient in PRIMSOL is trimethoprim hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the trimethoprim hydrochloride profile page.

Summary for PRIMSOL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	15
Patent Applications:	16
Drug Prices:	Drug price information for PRIMSOL
What excipients (inactive ingredients) are in PRIMSOL?	PRIMSOL excipients list
DailyMed Link:	PRIMSOL at DailyMed

See drug prices for PRIMSOL

US Patents and Regulatory Information for PRIMSOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074374-001	Jun 23, 1995		DISCN	No	No
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074973-001	Jan 24, 2000		DISCN	Yes	No

Expired US Patents for PRIMSOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074973-001	Jan 24, 2000
Pangea	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074973-001	Jan 24, 2000

International Patents for PRIMSOL

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

Country	Patent Number	Title	Estimated Expiration
Portugal	938302
Japan	3778518
Canada	2260852	COMPOSITION LIQUIDE AQUEUSE AU GOUT AGREABLE POUR MEDICAMENTAU GOUT AMER (PLEASANT-TASTING AQUEOUS LIQUID COMPOSITION OF A BITTER-TASTING DRUG)

PRIMSOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PRIMSOL

Introduction

PRIMSOL, a drug that has been part of the pharmaceutical landscape, particularly in the context of urology-focused companies, presents an interesting case study in market dynamics and financial trajectories. Here, we will delve into the key aspects of PRIMSOL, including its market position, financial performance, and the strategic decisions surrounding its development and commercialization.

Background on PRIMSOL

PRIMSOL, also known as trimethoprim, is an antibiotic used to treat various bacterial infections. In the context of AYTU Bioscience, Inc., PRIMSOL was one of the assets acquired and later divested as part of the company's strategic realignment.

Market Position

PRIMSOL operates within the broader antibiotic market, which is highly competitive and subject to stringent regulatory oversight. The antibiotic market is characterized by a high demand for effective treatments, but it is also marked by concerns over antibiotic resistance and the need for continuous innovation[1].

Acquisition and Divestment

AYTU Bioscience, Inc. acquired PRIMSOL as part of its strategy to expand its product portfolio, particularly within the urology segment. However, the company later divested PRIMSOL, indicating a shift in focus towards other more promising or strategically aligned assets. This decision reflects the dynamic nature of pharmaceutical companies' portfolios, where assets are constantly evaluated for their potential to drive growth and profitability[1].

Financial Performance

The financial performance of PRIMSOL during its tenure with AYTU Bioscience, Inc. would have been influenced by several factors, including sales revenue, research and development expenses, and general administrative costs. However, specific financial details for PRIMSOL alone are not readily available, as it was part of a broader portfolio.

Strategic Considerations

The decision to divest PRIMSOL likely stemmed from several strategic considerations:

Focus on Core Competencies

AYTU Bioscience, Inc. has a strong focus on urology and women’s health products. Divesting PRIMSOL allowed the company to concentrate resources on assets that align more closely with its core competencies, such as ProstaScint and the MiOXSYS System[1].

Market and Regulatory Environment

The antibiotic market is highly regulated, and the potential for revenue growth may be limited by factors such as generic competition and regulatory hurdles. Divesting PRIMSOL could have been a response to these market dynamics, allowing the company to allocate resources to areas with higher growth potential[1].

Financial Resource Allocation

Pharmaceutical companies often face significant financial pressures, particularly in research and development. By divesting PRIMSOL, AYTU Bioscience, Inc. could redirect financial resources towards more promising pipeline assets, such as the MiOXSYS System, which has shown potential in clinical trials and has received regulatory approvals in various regions[1].

Impact on Company Financials

The divestment of PRIMSOL would have had several financial implications for AYTU Bioscience, Inc.:

Revenue Stream

The loss of PRIMSOL as a revenue-generating asset would have reduced the company's overall revenue. However, this could be offset by the growth in sales from other products like ProstaScint and the potential future revenues from the MiOXSYS System[1].

Operational Costs

Divesting PRIMSOL would also reduce operational costs associated with its maintenance, marketing, and distribution. These savings could be reinvested in other areas of the business, such as research and development or commercialization of new products[1].

Conclusion on Market Dynamics

The market dynamics surrounding PRIMSOL reflect the broader challenges and opportunities in the pharmaceutical industry. Companies must continually evaluate their portfolios to ensure alignment with strategic goals and to maximize financial performance.

Key Takeaways

• Strategic Alignment: PRIMSOL's divestment was likely due to a strategic decision to focus on core competencies in urology and women’s health.
• Market Environment: The antibiotic market's competitive and regulatory landscape may have limited PRIMSOL's growth potential.
• Financial Resource Allocation: Divesting PRIMSOL allowed AYTU Bioscience, Inc. to redirect resources to more promising pipeline assets.
• Revenue and Operational Impacts: The divestment affected revenue streams but also reduced operational costs.

FAQs

1. Why was PRIMSOL divested by AYTU Bioscience, Inc.? PRIMSOL was divested as part of AYTU Bioscience, Inc.'s strategy to focus on its core competencies in urology and women’s health products.

2. What are the key challenges in the antibiotic market? The antibiotic market faces challenges such as generic competition, regulatory hurdles, and the increasing problem of antibiotic resistance.

3. How does the divestment of PRIMSOL impact AYTU Bioscience, Inc.'s financials? The divestment reduces revenue from PRIMSOL but also decreases operational costs, allowing the company to allocate resources to other promising assets.

4. What other products does AYTU Bioscience, Inc. focus on? AYTU Bioscience, Inc. focuses on products like ProstaScint for prostate cancer diagnosis and the MiOXSYS System for oxidative stress testing.

5. What is the significance of the MiOXSYS System for AYTU Bioscience, Inc.? The MiOXSYS System is significant as it has received regulatory approvals in Europe and Canada and is being advanced for FDA clearance in the U.S., representing a potential high-growth asset for the company.

References

1. AYTU BIOSCIENCE, INC - Annual Reports. Annual Reports. Retrieved from https://www.annualreports.com/HostedData/AnnualReportArchive/a/NASDAQ_AYTU_2017.pdf
2. Prime Medicine Reports Third Quarter 2024 Financial Results. GlobeNewswire. Retrieved from https://www.globenewswire.com/news-release/2024/11/12/2979623/0/en/Prime-Medicine-Reports-Third-Quarter-2024-Financial-Results-and-Provides-Business-Updates.html
3. Report: Obesity Drug Market Estimated to be Worth $200 Billion by 2031. PharmExec. Retrieved from https://www.pharmexec.com/view/report-obesity-drug-market-estimated-200-billion-2031
4. Expert analysis: Medical benefit drug trend is on the rise. Prime Therapeutics LLC. Retrieved from https://www.primetherapeutics.com/w/expert-analysis-medical-benefit-drug-trend-is-on-the-rise
5. Prime Medicine Reports First Quarter 2024 Financial Results and. Prime Medicine. Retrieved from https://investors.primemedicine.com/news-releases/news-release-details/prime-medicine-reports-first-quarter-2024-financial-results-and