FACTIVE Drug Patent Profile

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.

Summary for FACTIVE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	2
Patent Applications:	500
What excipients (inactive ingredients) are in FACTIVE?	FACTIVE excipients list
DailyMed Link:	FACTIVE at DailyMed

Recent Clinical Trials for FACTIVE

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

Sponsor	Phase
Samsung Medical Center	Phase 3
LG Life Sciences	Phase 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

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	6,723,734
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	5,633,262
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	6,331,550
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	6,262,071
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	5,776,944

International Patents for FACTIVE

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

Country	Patent Number	Title	Estimated Expiration
Norway	994595
Iceland	7952
Canada	2281817	METHODES D'UTILISATION DE COMPOSES DE FLUOROQUINOLONE CONTRE LES BACTERIES PATHOGENES DANS LE SINUS MAXILLAIRE (METHODS OF USE OF FLUOROQUINOLONE COMPOUNDS AGAINST MAXILLARY SINUS PATHOGENIC BACTERIA)
Hungary	0000728
Australia	6201600

Market Dynamics and Financial Trajectory for FACTIVE

Last updated: July 29, 2025

Introduction

FACTORIC (generic name: gemifloxacin mesylate) is an antibiotic belonging to the fluoroquinolone class, primarily marketed under the brand name FACTIVE by Genentech/Roche. Approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA) in 2003, FACTIVE is indicated for acute bacterial exacerbations of chronic bronchitis in adults and community-acquired pneumonia (CAP). With an increasing global prevalence of respiratory infections and evolving antimicrobial resistance, understanding the market dynamics and financial trajectory of FACTIVE is crucial for stakeholders across the pharmaceutical landscape.

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Market Dynamics of FACTIVE

1. Competitive Landscape

FACTORIC operates in a highly competitive segment of the antibiotics market, characterized by several generic and branded fluoroquinolones, including ciprofloxacin, levofloxacin, and moxifloxacin. Its unique position stems from its specific labeling for respiratory infections without broad-spectrum coverage. However, the market has seen a proliferation of generic versions following patent expirations, with major players reducing barriers for physicians favoring cost-effective options. Consequently, off-patent status has pressured FACTIVE's pricing and market share, forcing providers to differentiate through efficacy, safety profiles, and formulary placements.

2. Regulatory and Prescriptive Factors

Regulatory agencies, notably the FDA, have progressively tightened restrictions on fluoroquinolones due to safety concerns about adverse effects such as tendinopathy, neuropsychiatric effects, and aortic aneurysm risks [1]. In 2016, the FDA issued safety communications warning against the use of fluoroquinolones for uncomplicated infections when alternative treatments are available. These restrictions influence prescriber behavior, thereby constraining FACTIVE’s market growth.

3. Antimicrobial Resistance and Prescribing Trends

The rise of antimicrobial resistance (AMR) diminishes the efficacy of fluoroquinolones, leading clinicians to favor alternative therapies. Reduced susceptibility of common pathogens limits the clinical utility of FACTIVE, impacting sales volume. Conversely, FACTIVE’s targeted spectrum may preserve its role in specific cases, particularly where resistance patterns necessitate its use, but overall, the trend favors conservative prescribing.

4. Pricing Strategies and Market Penetration

Pricing remains a critical determinant. FACTIVE’s positioning has shifted toward niche markets where its specific indications and safety profile justify a premium. Contractual arrangements with hospitals, payers, and pharmacies influence accessibility. Additionally, the availability of generics has significantly lowered the price point, often leading to off-label substitution, further challenging FACTIVE’s revenue streams.

5. Geographic Market Considerations

The U.S. remains the primary market, driven by high healthcare expenditure and antibiotic consumption. Emerging markets, such as China, India, and parts of Latin America, present growth opportunities amid expanding healthcare infrastructure. However, regulatory hurdles and pricing sensitivities in these regions temper growth projections.

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Financial Trajectory of FACTIVE

1. Revenue Trends

FACTORIC’s revenues peaked shortly after its launch in the early 2000s, driven by its novel mechanism and targeted use for respiratory infections. Over subsequent years, sales stabilized and then declined as generic competitors entered and safety concerns dampened prescribing rates [2].

According to industry reports, FACTIVE’s global sales experienced a compound annual decline of approximately 3-5% from its peak around 2010–2015, primarily due to patent expiry and increased generic penetration. In 2022, estimates suggest annual revenues in the range of $100–120 million globally, with a significant portion derived from North America.

2. Margins and Cost Structures

Branded pharmaceuticals like FACTIVE typically enjoy higher gross margins initially, supported by pricing power and exclusivity. However, as generics enter and prescribing declines, profit margins compress. Cost structures associated with marketing, distribution, and regulatory compliance also influence profitability.

3. Impact of Patent Expiry and Generics

Since FACTIVE’s patent expiration in the U.S. around 2018, multiple generic formulations have entered the market. Generic competition has led to price erosion estimated at 30–50%, significantly reducing revenue per unit. The strategic response includes focusing on clinical differentiation and expanding indications, though these avenues have limited impact given regulatory and safety constraints.

4. Future Forecasts and Market Outlook

Forecasts project a continued decline in FACTIVE's revenues over the next five years, with a compound annual decrease of 2–4%, barring new indications or formulations. The potential for lifecycle extension exists through:

• Line extensions or formulations, such as shorter-course therapies or combination regimens.

• New indications, if regulatory agencies approve expanded uses, though current evidence and safety profile challenges may inhibit this pathway.

• Partnerships and licensing, allowing generic manufacturers to capture market share while maintaining certain revenues for patent-holders.

In summary, FACTIVE's financial trajectory is expected to remain subdued unless innovations or strategic repositioning occur.

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Market Drivers and Constraints

Drivers:

• Clinical efficacy in respiratory infections.
• Niche uses where resistance or safety issues restrict alternatives.
• Growing awareness of antibiotic stewardship, ensuring appropriate use.

Constraints:

• Safety concerns reducing prescribing.
• Generic competition eroding market share.
• Regulatory restrictions limiting indications.
• AMR trends diminishing efficacy.

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Key Market Trends Influencing FACTIVE

1. Antimicrobial Stewardship Initiatives: Efforts to curb overuse of fluoroquinolones reduce market size.
2. Safety Profile Scrutiny: Enhanced post-marketing surveillance impacts prescriber confidence.
3. Generic Market Penetration: Accelerated by patent expiry, pressuring branded revenues.
4. Expansion in Emerging Markets: Growth dependent on regulatory landscapes and affordability.
5. Innovation in Antibiotics: Encourages off-label or alternative therapies, reducing reliance on existing agents like FACTIVE.

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Conclusion

FACTORIC’s market landscape is shaped by intense competition, regulatory headwinds, safety concerns, and the pervasive impact of generic drug pricing. While it retains a position within targeted indications, its financial trajectory portends a gradual decline unless strategic adaptations or novel approvals extend its lifecycle. The industry’s shift toward antimicrobial stewardship and resistance mitigation further constrains growth but also accentuates the need for precisely targeted antibiotic use.

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Key Takeaways

• FACTIVE faces significant headwinds from generic competition, safety restrictions, and resistance trends, resulting in a declining revenue outlook.
• Its niche utility in respiratory infections offers some resilience, but broader market appeal is limited.
• Strategic differentiation, new indications, or formulation innovations are essential to alter its financial trajectory.
• Emerging markets present growth opportunities, albeit with regulatory and pricing challenges.
• Industry shifts favor antibiotic stewardship, emphasizing the importance of targeted, judicious use for existing agents like FACTIVE.

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FAQs

1. What factors have contributed to the decline of FACTIVE’s market share?
Patent expiry leading to generic competition, safety concerns prompting prescriber caution, and antimicrobial resistance decreasing efficacy have significantly eroded FACTIVE’s market share over recent years.

2. Are there new indications or formulations in development to revitalize FACTIVE?
Currently, no significant new formulations or indications have received regulatory approval; future prospects depend on clinical research outcomes and regulatory decisions.

3. How do safety concerns influence FACTIVE’s prescribing patterns?
Safety warnings, particularly regarding serious adverse effects, have led clinicians to reserve fluoroquinolone use for specific cases, reducing overall prescriptions of FACTIVE.

4. What is the impact of antimicrobial resistance on FACTIVE's future?
Rising resistance diminishes its effectiveness, prompting clinicians to prefer alternative antibiotics, thereby constraining future sales growth.

5. Can emerging markets offset declining sales in developed regions for FACTIVE?
While emerging markets offer growth potential, factors such as regulatory hurdles, pricing sensitivities, and local resistance patterns influence their ability to compensate for declining revenues elsewhere.

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References

[1] U.S. Food & Drug Administration. "FDA Drug Safety Communication: Safety review of fluoroquinolone antibiotics." 2016.
[2] Industry reports on antibiotic sales, 2022.