You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 11, 2025

FACTIVE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Factive is a drug marketed by Lg Chem Ltd and is included in one NDA.

The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Additional details are available on the gemifloxacin mesylate profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for FACTIVE?
  • What are the global sales for FACTIVE?
  • What is Average Wholesale Price for FACTIVE?
Summary for FACTIVE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 2
Patent Applications: 228
What excipients (inactive ingredients) are in FACTIVE?FACTIVE excipients list
DailyMed Link:FACTIVE at DailyMed
Drug patent expirations by year for FACTIVE
Recent Clinical Trials for FACTIVE

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

SponsorPhase
Samsung Medical CenterPhase 3
LG Life SciencesPhase 1

See all FACTIVE clinical trials

Paragraph IV (Patent) Challenges for FACTIVE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FACTIVE Tablets gemifloxacin mesylate 320 mg 021158 1 2008-03-04

US Patents and Regulatory Information for FACTIVE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FACTIVE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 6,262,071 ⤷  Try for Free
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 5,633,262 ⤷  Try for Free
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 6,803,376 ⤷  Try for Free
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 6,340,689 ⤷  Try for Free
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 5,776,944 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FACTIVE

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

Country Patent Number Title Estimated Expiration
Bulgaria 63972 ⤷  Try for Free
Czech Republic 288715 Solvát methansulfonátu kyseliny 7-(3-aminomethyl-4-methoxyiminopyrrolidin-1-yl)-1-cyklopropyl-6-fluor-4-oxo-1,4-dihydro-1,8-nafthydrin-3-karboxylové (Solvate of 7-(3-aminomethyl-4-methoxyiminopyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthhydrin-3-carboxylic acid methane sulfonate) ⤷  Try for Free
Spain 2299430 ⤷  Try for Free
South Korea 100222082 ⤷  Try for Free
Indonesia 22681 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for the Drug: FACTIVE

Introduction

FACTIVE, the trade name for gemifloxacin mesylate, is a fluoroquinolone antibiotic used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. To understand the market dynamics and financial trajectory of FACTIVE, it is crucial to analyze various factors including market trends, competition, pricing, and the overall pharmaceutical landscape.

Market Overview of Gemifloxacin Mesylate

Gemifloxacin mesylate is a broad-spectrum antibacterial agent. The market for this drug is influenced by several key factors:

Export and Import Dynamics

India is the largest exporter of gemifloxacin mesylate API, followed by China, although China exports smaller quantities. The export of the API from India has seen fluctuations, with an increase in recent years but a decline in 2021. Major importing countries include Egypt, Bangladesh, and Pakistan[4].

Major Markets

The drug is imported by several countries, with Nigeria and Myanmar being key markets. Other significant importers include Malaysia, Palau, and Singapore[4].

Competitive Landscape

The competitive landscape for FACTIVE is complex, with multiple players in the generic and branded markets.

Generic Competition

The US generic-drug industry, including drugs like FACTIVE, faces significant challenges. Generic-drug prices are eroding rapidly, and new challengers are entering the market with low-price products. This competition is exacerbated by pharmacies and wholesalers leveraging their purchasing power to drive down prices[3].

First-to-File and First-to-Market Strategies

Companies that are first-to-file (FTF) and first-to-market (FTM) with generic versions of drugs like FACTIVE can still generate substantial returns during their exclusivity period. However, this market has become more competitive, especially with Indian companies improving their capabilities in navigating Paragraph IV (PIV) challenges and FTM strategies[3].

Pricing and Revenue Trends

Pricing dynamics play a critical role in the financial trajectory of FACTIVE.

Pricing Erosion

The generic-drug market, including FACTIVE, is experiencing rapid price erosion. This is driven by intense competition and the consolidation of purchasing power among pharmacies and wholesalers. As a result, the revenue generated from these drugs is under pressure[3].

Net Manufacturer Revenue

The net manufacturer revenue for drugs like FACTIVE has seen a decline due to increased discounts, rebates, and coupons. Between 2010 and 2020, while net spending by all payers increased by 20%, manufacturer net revenue grew by only 5%[1].

Financial Feasibility and Investment

The development and marketing of drugs like FACTIVE involve significant financial investments.

Research and Development Costs

The cost of researching and developing new drug formulations, including sustained-release forms, is high. For instance, the cost for developing a new drug can range from $1.46 million to $18.60 million, depending on the complexity and duration of the R&D process[2].

Payback Period and Market Growth

Financial feasibility studies indicate that investors need to generate substantial income to cover the invested capital. For a drug like FACTIVE, the payback period can range from 5 to 10 years, with required annual income varying based on the duration of R&D and market growth rates[2].

Case Study: Oscient Pharmaceuticals

Oscient Pharmaceuticals, the original marketer of FACTIVE, provides a real-world example of the challenges faced by companies in this market.

Layoffs and Marketing Cuts

In 2009, Oscient Pharmaceuticals laid off 180 sales, marketing, and corporate employees due to patent expirations and generic competition. The company ceased all promotion activities for FACTIVE and another treatment, Antara, to adjust to the changing market landscape[5].

Impact of Generic Competition

The introduction of generic versions of FACTIVE significantly impacted Oscient's revenue. Despite continuing to support and sell the drug, the company's financial trajectory was adversely affected by the loss of exclusivity and the subsequent generic competition[5].

Market Growth Drivers and Challenges

The market for FACTIVE is driven by several factors, each with its own set of challenges.

Innovation and New Products

New products and innovations in the pharmaceutical sector drive growth, but they also face challenges such as losses of exclusivity and the impact of biosimilars. For example, in the oncology sector, growth has been driven by new products, but recent growth has slowed due to the impact of biosimilars[1].

Volume Usage and Generic Share

The generic share of the combined generic and loss of exclusivity (LOE) segments has been increasing steadily. This shift towards generics affects the revenue of branded drugs like FACTIVE, as more patients opt for cheaper generic alternatives[1].

Future Outlook

The future outlook for FACTIVE and similar drugs is influenced by several key trends:

Continued Competition

The generic-drug market will continue to be highly competitive, with companies needing to adopt strategies such as being first-to-file and first-to-market, engaging in the active pharmaceutical ingredient (API) business, and excelling at complex generics to maintain profitability[3].

Market Stabilization

Although the US generic-drug industry has recently begun to stabilize, companies will need to move away from a reliance on generics and focus on higher-value, differentiated products to achieve sustainable growth and profitability[3].

Regulatory and Pricing Pressures

Regulatory inquiries into pricing and marketing practices will continue to affect the valuations of pharmaceutical companies. Companies must navigate these challenges while maintaining compliance with regulatory requirements[3].

Key Takeaways

  • Market Competition: The generic-drug market, including FACTIVE, is highly competitive with rapid price erosion and intense competition.
  • Financial Feasibility: Developing and marketing drugs like FACTIVE requires significant financial investment, with payback periods ranging from 5 to 10 years.
  • Pricing Dynamics: Net manufacturer revenue is under pressure due to increased discounts, rebates, and coupons.
  • Innovation and Generic Share: Growth is driven by new products, but generic share is increasing, affecting branded drug revenues.
  • Future Outlook: Companies need to adopt strategies like FTF-FTM, API business, and complex generics to remain profitable.

FAQs

What are the main challenges facing the generic-drug market, including FACTIVE?

The main challenges include rapid price erosion, intense competition, and the consolidation of purchasing power among pharmacies and wholesalers.

How does the first-to-file and first-to-market strategy impact the revenue of generic drugs like FACTIVE?

Being first-to-file and first-to-market can generate substantial returns during the exclusivity period, but this market has become more competitive, especially with Indian companies improving their capabilities.

What is the impact of biosimilars on the market for branded drugs like FACTIVE?

Biosimilars can slow down the growth of branded drugs by offering cheaper alternatives, as seen in the oncology sector where biosimilars have impacted recent growth.

How do regulatory inquiries affect pharmaceutical companies like Oscient Pharmaceuticals?

Regulatory inquiries into pricing and marketing practices can create uncertainty and adversely affect the valuations of pharmaceutical companies.

What strategies can companies adopt to maintain profitability in the generic-drug market?

Companies can adopt strategies such as being first-to-file and first-to-market, engaging in the active pharmaceutical ingredient (API) business, excelling at complex generics, and consolidating to achieve advantage economics.

Sources

  1. IQVIA Institute. Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context U.S Detail Appendix.
  2. medRxiv. Financial Feasibility Study and policy recommendations.
  3. Boston Consulting Group. The Paths to Value for US Generics.
  4. Macsen Labs. Gemifloxacin Mesylate | Market Insights, Price and Trends of this drug.
  5. Pharmaceutical Executive. Oscient Pharmaceuticals Lays Off 180 Reps.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.