TROVAN Drug Patent Profile

When do Trovan patents expire, and what generic alternatives are available?

Trovan is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in TROVAN is azithromycin dihydrate; trovafloxacin mesylate. There are thirty-two drug master file entries for this compound. Additional details are available on the azithromycin dihydrate; trovafloxacin mesylate profile page.

Summary for TROVAN

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	44
Patent Applications:	898
DailyMed Link:	TROVAN at DailyMed

US Patents and Regulatory Information for TROVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN/ZITHROMAX COMPLIANCE PAK	azithromycin dihydrate; trovafloxacin mesylate	FOR SUSPENSION, TABLET;ORAL	050762-001	Dec 18, 1998		DISCN	No	No

Expired US Patents for TROVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-001	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997
Pfizer	TROVAN	trovafloxacin mesylate	TABLET;ORAL	020759-002	Dec 18, 1997

International Patents for TROVAN

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

Country	Patent Number	Title	Estimated Expiration
Poland	286484
South Africa	9900393
European Patent Office	0413455	Acides azabicyclo quinoline carboxyliques. (Azabicyclo quinolone carboxylic acids.)
Bulgaria	62443
China	1049501

Supplementary Protection Certificates for TROVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0413455	SPC/GB98/046	United Kingdom		PRODUCT NAME: ALATROVAFLOXACIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE MESYLATE SALT.; REGISTERED: CH 54484 19980327; UK EU/1/98/060/001 19980703; UK EU/1/98/060/002 19980703; UK EU/1/98/060/003 19980703
0413455	SPC/GB98/045	United Kingdom		PRODUCT NAME: TROVAFLOXACIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE MESYLATE SALT.; REGISTERED: CH 54483 19980327; UK EU/1/98/059/001 19980703; UK EU/1/98/059/002 19980703; UK EU/1/98/059/003 19980703; UK EU/1/98/059/004 19980703; UK EU/1/98/059/005 19980703; UK EU/1/98/059/006 19980703; UK EU/1/98/059/007 19980703; UK EU/1/98/059/008 19980703; UK EU/1/98/059/009 19980703; UK EU/1/98/059/010 19980703; UK EU/1/98/059/011 19980703; UK EU/1/98/059/012 19980703
0413455	98C0039	Belgium		PRODUCT NAME: TROVAFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/059/001 19980703; FIRST REGISTRATION: CH 54483 19980327
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327

TROVAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for New Drug Modalities: A Focus on Emerging Trends

Introduction

The pharmaceutical industry is undergoing a significant transformation driven by the emergence of new drug modalities. These innovative approaches are reshaping the market dynamics and financial trajectories of pharmaceutical companies. Here, we will delve into the current state and future outlook of these new drug modalities, using examples and data to illustrate their impact.

Growth of New Drug Modalities

New drug modalities have experienced rapid growth over the past few years. From 2019 to 2021, these modalities saw a compound annual growth rate (CAGR) of 28%, driven by advancements in monoclonal antibodies (mAb), antibody-drug conjugates (ADC), recombinant proteins, bispecific antibodies (BsAb), and mRNA drugs[1].

Current Market Value

As of 2024, new drug modalities represent a significant portion of the pharmaceutical pipeline, with a projected value of $168 billion, up 14% from 2023. This growth indicates a strong market demand and investor confidence in these innovative treatments[1].

Pipeline Revenue and Deal Activity

The pipeline revenue for new modalities is closely monitored, with projections indicating substantial growth. For instance, the five-year forward-projected revenue for these modalities reflects their economic potential and the likelihood of successful pipeline progression. Deal activity, particularly in ADC, CAR-T, and RNAi, has been robust, with early-stage deals outnumbering late-stage deals[1].

Impact on Pharmaceutical Companies

Pfizer's Strategic Positioning

Pfizer, one of the industry leaders, has solidified its position through strategic acquisitions and a strong pipeline. The acquisition of Seagen is expected to contribute significantly to Pfizer's revenue, with anticipated revenues of $3.1 billion in 2024. Pfizer's full-year 2024 revenue guidance ranges from $58.5 to $61.5 billion, including contributions from Comirnaty, Paxlovid, and Seagen[2].

Cost Realignment and R&D Expenses

Pfizer has initiated a cost realignment program aimed at reducing R&D and selling, general, and administrative (SG&A) expenses by an estimated $4 billion annually. This program is expected to help the company regain pre-pandemic operating margins by the end of 2024. R&D expenses remain a critical component of Pfizer's strategy, accounting for 18.26% of sales in 2023[3].

Emerging Modalities and Their Market Potential

Recombinant Proteins

Recombinant proteins, such as GLP-1 agonists, are expected to dominate the market in the coming years. By 2029, five of the top 10 drugs by revenue are projected to be recombinant proteins, highlighting their significant market potential[1].

mRNA Drugs

mRNA drugs, exemplified by Pfizer's Comirnaty, have shown remarkable success, particularly during the COVID-19 pandemic. These drugs continue to be a focus area for innovation and investment.

CAR-T and ADC

CAR-T cell therapies and ADCs are also gaining traction, with substantial deal activity and pipeline growth. These modalities are particularly promising in the treatment of cancers and other complex diseases[1].

Financial Trajectory

Revenue Growth

The financial trajectory for companies investing in new drug modalities is promising. Pfizer, for example, expects operational revenue growth of 8% to 10% in 2024, excluding revenues from Comirnaty and Paxlovid. This growth is driven by the combined portfolio of Pfizer and Seagen, as well as the launch of new products[2].

Cost of Goods Sold (COGS)

The COGS for pharmaceutical companies is expected to decrease in the coming years, partly due to lower inflationary expectations and the reduced initial high costs associated with COVID-19 products. Pfizer anticipates its COGS to come down, contributing to an expected gross margin of 70% by the end of 2024[3].

Market Insights and Trends

Global Drug Discovery Technologies Market

The global drug discovery technologies market has grown significantly, reaching a value of nearly $66.07 billion in 2023 with a CAGR of 9.8% since 2018. This market is expected to continue growing, driven by increased R&D expenditure and demand for personalized medicine[4].

Regulatory and Competitive Landscape

The regulatory landscape remains complex, with time-consuming approval processes. However, favorable government initiatives and the increasing demand for innovative treatments are driving growth. The market is highly competitive, with companies like AstraZeneca, Merck, and GlaxoSmithKline leading the way[4].

Case Study: Travere Therapeutics

Travere Therapeutics provides a compelling example of the financial and market dynamics surrounding new drug modalities. Their drug, FILSPARI (sparsentan), received accelerated FDA approval in 2023 and has shown significant commercial progress. Net product sales for FILSPARI totaled $27.1 million in the second quarter of 2024, representing 37% growth over the previous quarter. This success underscores the potential for new modalities to drive revenue growth and market expansion[5].

Key Takeaways

• Rapid Growth: New drug modalities have experienced rapid growth, driven by advancements in mAb, ADC, recombinant proteins, BsAb, and mRNA drugs.
• Market Value: These modalities represent a significant portion of the pharmaceutical pipeline, with a projected value of $168 billion in 2024.
• Pipeline Revenue: Strong pipeline revenue projections indicate substantial economic potential.
• Deal Activity: Robust deal activity, particularly in ADC, CAR-T, and RNAi, reflects investor confidence.
• Cost Realignment: Pharmaceutical companies are focusing on cost realignment to improve operating margins.
• Emerging Modalities: Recombinant proteins, mRNA drugs, CAR-T, and ADC are expected to dominate the market in the coming years.
• Financial Trajectory: Companies investing in new drug modalities anticipate significant revenue growth and improved margins.

FAQs

What are the key new drug modalities driving market growth?

The key new drug modalities include monoclonal antibodies (mAb), antibody-drug conjugates (ADC), recombinant proteins, bispecific antibodies (BsAb), and mRNA drugs.

How is Pfizer's acquisition of Seagen expected to impact its revenue?

Pfizer's acquisition of Seagen is expected to contribute approximately $3.1 billion in revenues in 2024 and drive significant top-line growth.

What is the projected market value of new drug modalities in 2024?

The projected market value of new drug modalities in 2024 is $168 billion, up 14% from 2023.

How is the global drug discovery technologies market expected to grow?

The global drug discovery technologies market is expected to grow from $66.07 billion in 2023 to $188.64 billion by 2033, with a CAGR of 10.8% from 2028.

What are the main drivers of revenue growth for pharmaceutical companies investing in new drug modalities?

The main drivers include the launch of new products, cost realignment programs, and the integration of acquired companies like Seagen.

Sources

1. BCG's 2024 New Drug Modalities Report: https://www.bcg.com/publications/2024/new-drug-modalities-report
2. Pfizer Provides Full-Year 2024 Guidance: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provides-full-year-2024-guidance
3. Krause Fund Research - Pfizer: https://students.tippie.uiowa.edu/sites/students.tippie.uiowa.edu/files/2024-04/s24_PFE.pdf
4. Global Drug Discovery Technologies Market Insights: https://www.globenewswire.com/news-release/2024/07/15/2913101/28124/en/Global-Drug-Discovery-Technologies-Market-Insights-2024-2033-Top-10-Companies-Account-for-26-61-of-the-Total-Market-AstraZeneca-Leads-with-5-73-Share-Followed-by-Merck-and-GlaxoSmi.html
5. Travere Therapeutics Reports Second Quarter 2024 Financial Results: https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-reports-second-quarter-2024-financial