GATIFLOXACIN - Generic Drug Details

What are the generic drug sources for gatifloxacin and what is the scope of freedom to operate?

Gatifloxacin is the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, Torrent, Allergan, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for gatifloxacin. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for GATIFLOXACIN

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	33
Patent Applications:	7,123
Drug Prices:	Drug price trends for GATIFLOXACIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GATIFLOXACIN
What excipients (inactive ingredients) are in GATIFLOXACIN?	GATIFLOXACIN excipients list
DailyMed Link:	GATIFLOXACIN at DailyMed

See drug prices for GATIFLOXACIN

See drug sales revenues for GATIFLOXACIN

Recent Clinical Trials for GATIFLOXACIN

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

Sponsor	Phase
Khyber Medical University Peshawar	Phase 1
Shaheed Benazir Bhutto University Sheringal Dir Upper	Phase 1
Laboratorios Sophia S.A de C.V.	Phase 3

See all GATIFLOXACIN clinical trials

Generic filers with tentative approvals for GATIFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		0.3%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for GATIFLOXACIN

Drug Class

Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for GATIFLOXACIN

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for GATIFLOXACIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYMAXID	Ophthalmic Solution	gatifloxacin	0.5 %	022548	1	2010-12-07
ZYMAR	Ophthalmic Solution	gatifloxacin	0.3 %	021493	1	2007-07-19

US Patents and Regulatory Information for GATIFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	206446-001	Jun 8, 2018		DISCN	No	No
Sandoz	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	204227-001	Jul 11, 2016	AT	RX	No	No
Apotex Inc	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	079084-001	Aug 19, 2011		DISCN	No	No
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003		DISCN	Yes	No

Expired US Patents for GATIFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	6,333,045*PED
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003	4,980,470*PED
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	5,880,283*PED
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003	6,333,045*PED

GATIFLOXACIN Market Analysis and Financial Projection Experimental

Gatifloxacin Market Dynamics and Financial Trajectory

Introduction to Gatifloxacin

Gatifloxacin is a broad-spectrum antibiotic belonging to the fluoroquinolone class, widely used for treating various bacterial infections. It is available in several forms, including ophthalmic solutions, injections, tablets, and capsules.

Market Size and Forecast

The gatifloxacin market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market was valued at USD 315.49 million and is expected to reach USD 331.32 million in 2024. By 2030, the market is forecasted to grow to USD 440.46 million, exhibiting a Compound Annual Growth Rate (CAGR) of 4.88%[4].

Growth Drivers

Several factors are driving the growth of the gatifloxacin market:

Rising Incidence of Bacterial Infections

The increasing prevalence of bacterial infections, particularly those resistant to other antibiotics, has boosted the demand for gatifloxacin. This rise in infections is a significant driver, as gatifloxacin's broad-spectrum efficacy makes it a preferred treatment option[2].

Technological Advancements in Drug Delivery Systems

Advancements in drug delivery systems have enhanced the efficacy and patient compliance of gatifloxacin. Improved formulations and delivery methods have made the drug more effective and easier to administer, contributing to its growing market[2].

Market Segmentation

The gatifloxacin market is segmented based on several criteria:

By Type

• Purity ≥ 99%: This segment includes high-purity gatifloxacin API, which is crucial for pharmaceutical applications.
• Purity < 99%: This segment includes lower purity gatifloxacin API, often used in research or less stringent applications[2].

By Application

• Ophthalmic Drops: Gatifloxacin is commonly used in ophthalmic solutions for treating bacterial conjunctivitis and other eye infections[3].
• Injection: Used for systemic infections, gatifloxacin injections are administered intravenously.
• Tablet & Capsules: Oral forms of gatifloxacin are used for treating a variety of bacterial infections[2].

Market Dynamics

The gatifloxacin market is characterized by a dynamic interplay of supply and demand factors.

Drivers

• Increasing Demand for Broad-Spectrum Antibiotics: The rise in antibiotic-resistant bacteria has increased the demand for broad-spectrum antibiotics like gatifloxacin.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing countries, have expanded the reach and accessibility of gatifloxacin[4].

Restraints

• Regulatory Challenges: Strict regulatory requirements and the need for continuous clinical trials can act as restraints to market growth.
• Side Effects and Safety Concerns: Like other fluoroquinolones, gatifloxacin can have side effects, which may limit its use in certain patient populations[4].

Opportunities

• Emerging Markets: Growing healthcare needs in emerging markets present significant opportunities for the gatifloxacin market.
• Research and Development: Continuous R&D in improving drug delivery systems and reducing side effects can open new avenues for market expansion[4].

Challenges

• Competition from Other Antibiotics: The presence of other effective antibiotics can pose a challenge to the market growth of gatifloxacin.
• Antibiotic Resistance: The ongoing issue of antibiotic resistance requires constant monitoring and adaptation, which can be a challenge for the market[4].

Financial Trajectory

The financial trajectory of the gatifloxacin market is promising, with steady growth projected over the next few years.

Current Valuation

As of 2023, the gatifloxacin market was valued at USD 315.49 million. This valuation is expected to increase to USD 331.32 million in 2024[4].

Future Projections

By 2030, the market is forecasted to reach USD 440.46 million, with a CAGR of 4.88%. Another projection indicates that the gatifloxacin API market will reach USD 597.3 million by 2032, exhibiting a CAGR of 4.20%[2][4].

Porter's Five Forces Analysis

To navigate the gatifloxacin market strategically, it is essential to analyze it using Porter's Five Forces:

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers to entry, including regulatory approvals and significant R&D investments[4].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low because there are multiple suppliers of gatifloxacin API, which reduces their negotiating power[4].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, as they have some flexibility in choosing between different antibiotics, but gatifloxacin's unique benefits can retain customer loyalty[4].

Threat of Substitute Products

The threat of substitute products is high due to the availability of other antibiotics and potential new treatments in the pipeline[4].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, as several pharmaceutical companies are involved in the production and marketing of gatifloxacin and other antibiotics[4].

Conclusion

The gatifloxacin market is poised for significant growth driven by increasing demand for broad-spectrum antibiotics, technological advancements, and expanding healthcare infrastructure. While regulatory challenges and side effects pose restraints, the market's financial trajectory indicates a robust future with projected valuations reaching USD 440.46 million by 2030.

Key Takeaways

• The gatifloxacin market is valued at USD 315.49 million in 2023 and is expected to grow to USD 440.46 million by 2030.
• The market is driven by the rising incidence of bacterial infections and technological advancements in drug delivery systems.
• Key market segments include purity levels and applications such as ophthalmic drops, injections, and tablets/capsules.
• The market faces challenges like regulatory hurdles and antibiotic resistance but offers opportunities in emerging markets and R&D.

FAQs

What is the current valuation of the gatifloxacin market?

The gatifloxacin market was valued at USD 315.49 million in 2023[4].

What is the projected CAGR of the gatifloxacin market from 2023 to 2030?

The projected CAGR is 4.88% from 2023 to 2030[4].

What are the key drivers of the gatifloxacin market?

The key drivers include the rising incidence of bacterial infections and technological advancements in drug delivery systems[2].

What are the main applications of gatifloxacin?

The main applications include ophthalmic drops, injections, and tablets/capsules[2].

What is the expected market size of the gatifloxacin API market by 2032?

The gatifloxacin API market is expected to reach USD 597.3 million by 2032[2].

Sources

1. Market Research Intellect: Gatifloxacin Market Size and Forecast.
2. The Market Intelligence: Gatifloxacin API Market Size, Share, Growth, and Industry Analysis.
3. FDA: 021493 Gatifloxacin Clinical BPCA.
4. 360iResearch: Gatifloxacin Market by Route of Administration, Form, Indication.