ZYMAR Drug Patent Profile

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

Zymar is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in ZYMAR is gatifloxacin. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zymar

A generic version of ZYMAR was approved as gatifloxacin by LUPIN LTD on August 28^th, 2013.

Summary for ZYMAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	140
Patent Applications:	5,576
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYMAR
DailyMed Link:	ZYMAR at DailyMed

Paragraph IV (Patent) Challenges for ZYMAR

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

US Patents and Regulatory Information for ZYMAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003		DISCN	Yes	No

Expired US Patents for ZYMAR

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

International Patents for ZYMAR

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

Country	Patent Number	Title	Estimated Expiration
Hungary	203339	PROCESS FOR PRODUCING NEW 8-ALKOXY-QUINOLONE-CARBOXYLIC ACID DERIVATIVES
New Zealand	504017	Preparation of gatifloxacin and disodium edetate
South Korea	100595956
Hong Kong	79797	8-alkoxyquinolonecarboxylic acid and salts thereof excellent in the selective toxicity and process of preparing the same
China	1021052
Japan	H0692937	8-ALKOXYQUINOLONECARBOXYLIC ACID EXCELLENT IN SELECTIVE TOXICITY AND SALT THEREOF AND ITS PRODUCTION

Supplementary Protection Certificates for ZYMAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0230295	300110	Netherlands
0230295	C300110	Netherlands		PRODUCT NAME: GATIFLOXACINUM, DESGEWENST IN DE VORM VAN EEN HYDRAAT, ZUURADDITIEZOUT OF ALKALISCH ZOUT, IN HET BIJZONDER GATIFLOXACINUM SESQUIHYDRICUM; REGISTRATION NO/DATE: DE 48870.00.00, 48870.01.00, 48872.00.00, 48872.01.00, 48874.00.00, 48874.01.00, 48876.00.00, 48876.01.00 20011022

ZYMAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZYMAR

Introduction

ZYMAR, a gatifloxacin ophthalmic solution, is a fluoroquinolone antibiotic used to treat bacterial conjunctivitis. Developed and marketed by Allergan (now part of AbbVie), ZYMAR has been a significant player in the ophthalmic pharmaceutical market since its approval in 2003.

Regulatory Approval and Product Line Extension

ZYMAR was initially approved by the FDA on March 28, 2003, for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria[2]. In 2010, Allergan introduced ZYMAXID, a higher concentration version of ZYMAR, which was approved after a thorough review to ensure that the new proprietary name did not lead to medication errors[1].

Market Position and Sales Performance

ZYMAR has been a part of Allergan's robust portfolio of ophthalmic products. The company's focus on six distinct medical specialties, including ophthalmology, has helped in establishing leading market share positions. ZYMAR, along with its higher concentration counterpart ZYMAXID, has contributed to Allergan's growth in the ophthalmic segment.

Sales Growth

In the early 2010s, Allergan experienced significant sales growth, driven in part by its ophthalmic products. The company's sales in emerging markets, where many ophthalmic products are cash-pay, increased by 25% in 2011, representing 17% of Allergan's total sales[3].

Geographic Performance

Allergan's success with ZYMAR and other products was not limited to developed markets. The company saw substantial growth in emerging markets in Asia, Latin America, and Eastern Europe. This geographic diversification helped in mitigating risks associated with economic fluctuations in any single region[3].

Financial Trajectory

Revenue Contribution

While specific revenue figures for ZYMAR alone are not detailed in the annual reports, the overall performance of Allergan's ophthalmic segment has been robust. In 2011, Allergan's total sales grew by 10.9% in dollars and 9.2% in local currencies, with a significant portion attributed to ophthalmic and other specialty products[3].

Research and Development Investments

Allergan's strategy included vigorous investments in research and development (R&D). In 2011, R&D expenditures increased by 12.6% to $858 million, which was 16% of the company's sales. This investment helped in strengthening the pipeline and securing new product approvals, including those in the ophthalmic segment[3].

Competitive Landscape

The ophthalmic antibiotic market is competitive, with several other fluoroquinolones and antibiotics available. However, ZYMAR's efficacy and safety profile, as demonstrated in clinical trials, have helped it maintain a strong market position. For instance, clinical trials showed that ZYMAR was superior to its vehicle in treating bacterial conjunctivitis, with a clinical cure rate of 77% and a microbiological eradication rate of 92%[2].

Adverse Events and Safety Profile

Like other fluoroquinolones, ZYMAR is associated with potential adverse events, including hypersensitivity reactions, taste disturbances, and conjunctival disorders. However, these events are generally manageable, and the drug's overall safety profile supports its continued use in treating bacterial conjunctivitis[4].

Market Dynamics and Trends

Emerging Markets

The growth in emerging markets has been a key trend for Allergan and other pharmaceutical companies. The lack of comprehensive healthcare systems and private insurance in these regions means that many ophthalmic products, including ZYMAR, are effectively cash-pay, contributing significantly to the company's revenue[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products. The FDA's approval process, including the review of proprietary names to prevent medication errors, ensures that products like ZYMAR and ZYMAXID meet stringent safety standards[1].

Patient and Physician Preferences

Patient and physician preferences also influence market dynamics. The efficacy, safety, and ease of use of ZYMAR have made it a preferred choice among healthcare providers for treating bacterial conjunctivitis.

Key Takeaways

• Regulatory Approval: ZYMAR was approved by the FDA in 2003, with a higher concentration version, ZYMAXID, approved later.
• Sales Performance: ZYMAR contributed to Allergan's sales growth, particularly in emerging markets.
• Financial Trajectory: Allergan's investments in R&D and its focus on ophthalmic products helped in maintaining a strong financial position.
• Competitive Landscape: ZYMAR's efficacy and safety profile have helped it compete effectively in the ophthalmic antibiotic market.
• Market Trends: Growth in emerging markets and the regulatory environment are key factors influencing the market dynamics of ZYMAR.

FAQs

What is ZYMAR used for?

ZYMAR is used to treat bacterial conjunctivitis caused by susceptible strains of bacteria.

When was ZYMAR approved by the FDA?

ZYMAR was approved by the FDA on March 28, 2003.

What is the difference between ZYMAR and ZYMAXID?

ZYMAXID is a higher concentration version of ZYMAR, containing 0.5% gatifloxacin ophthalmic solution compared to ZYMAR's 0.3%.

What are the common adverse events associated with ZYMAR?

Common adverse events include hypersensitivity reactions, taste disturbances, and conjunctival disorders.

How has ZYMAR contributed to Allergan's financial performance?

ZYMAR has contributed to Allergan's sales growth, particularly in emerging markets, and has been part of the company's robust ophthalmic product portfolio.

Sources

1. FDA Review Document: "22548Orig1s000 - accessdata.fda.gov"
2. ZYMAR Label: "NDA 21-493/S-006 & S-007 - accessdata.fda.gov"
3. Allergan Annual Report 2011: "Annual Reports - annualreports.com"
4. ZYMAR Product Monograph: "ZYMAR_PM_EN - AbbVie.ca"
5. RxList: "Zymar (Gatifloxacin Ophthalmic Solution) - RxList"