ZYMAXID Drug Patent Profile

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

Zymaxid is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ZYMAXID 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 Zymaxid

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

Summary for ZYMAXID

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	1
Patent Applications:	4,437
Drug Prices:	Drug price information for ZYMAXID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYMAXID
What excipients (inactive ingredients) are in ZYMAXID?	ZYMAXID excipients list
DailyMed Link:	ZYMAXID at DailyMed

See drug prices for ZYMAXID

See drug sales revenues for ZYMAXID

Recent Clinical Trials for ZYMAXID

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

Sponsor	Phase
Discover Vision Centers
Toyos Clinic

See all ZYMAXID clinical trials

Pharmacology for ZYMAXID

Drug Class

Quinolone Antimicrobial

Paragraph IV (Patent) Challenges for ZYMAXID

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

US Patents and Regulatory Information for ZYMAXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	AT	RX	Yes	Yes

Expired US Patents for ZYMAXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010

International Patents for ZYMAXID

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

Country	Patent Number	Title	Estimated Expiration
Hungary	227795	8-ALKOXYQUINOLONECARBOXYLIC ACID HYDRATE WITH EXCELLENT STABILITY AND PROCESS FOR PRODUCING THE SAME
Spain	2173982
Canada	2208704	HYDRATE D'ACIDE 8-ALCOXYQUINOLONECARBOXYLIQUE AYANT UNE EXCELLENTE STABILITE ET PROCEDE DE FABRICATION (8-ALKOXYQUINOLONECARBOXYLIC ACID HYDRATE WITH EXCELLENT STABILITY AND PROCESS FOR PRODUCING THE SAME)
Taiwan	393479

Supplementary Protection Certificates for ZYMAXID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

ZYMAXID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZYMAXID

Overview of ZYMAXID

ZYMAXID, or gatifloxacin ophthalmic solution, is a fluoroquinolone antibiotic specifically designed to treat bacterial conjunctivitis. Here’s a detailed look at the market dynamics and financial trajectory surrounding this drug.

Clinical Efficacy and Usage

ZYMAXID has been clinically proven to be effective in treating bacterial conjunctivitis. In clinical trials, it demonstrated a clinical success rate of 58% in resolving conjunctival hyperaemia and discharge, compared to 45% for the vehicle-treated groups. Additionally, it showed a statistically superior microbiological eradication rate of 90% for causative pathogens[4].

Market Trends for Bacterial Conjunctivitis Drugs

The U.S. market for bacterial conjunctivitis drugs, including ZYMAXID, has been experiencing significant challenges.

Declining Market Opportunity

The market for bacterial conjunctivitis drugs has been declining sharply over the last few years and is projected to continue this trend. In 2013, the market opportunity was valued at $473.3 million, which is expected to reduce to $439.8 million by 2024[1].

Genericization and Patent Expiries

One of the major factors contributing to this decline is the growing genericization of antibacterial drugs. Generic versions of patented formulations, such as those of ZYMAXID, are available at much lower prices, increasing sales volume but reducing revenues for branded drugs. The patent expirations of top brands like ZYMAXID, Vigamox, and Moxeza are set to further exacerbate this issue[1].

Impact on Topical Fluoroquinolones

ZYMAXID, being a topical fluoroquinolone, is particularly affected by these market dynamics. The demand for topical fluoroquinolones, which is currently the highest among all classes of bacterial conjunctivitis drugs, is expected to decline significantly due to the encroachment by generic variations. The segment is projected to decline from $361.9 million in 2013 to $286.4 million by 2024[1].

Financial Implications

Revenue and Market Share

The financial implications of these trends are substantial for the manufacturers of ZYMAXID. The loss of marketing exclusivity and the rise of generic alternatives have led to a significant reduction in revenue. For instance, the decline in the market opportunity for topical fluoroquinolones directly impacts the sales and profitability of ZYMAXID.

Pharmaceutical Company Financials

Pharmaceutical companies that rely heavily on branded ophthalmic drugs like ZYMAXID have incurred significant losses due to generic cannibalization. This is evident in the financial reports of companies that have seen a decline in net income and revenue from these products. For example, the financial strain due to patent expiries and generic competition can be seen in the broader context of the pharmaceutical industry, where companies are seeking strategic alliances and product development partnerships to mitigate these losses[1].

Challenges and Future Outlook

Multi-Drug Resistant Organisms (MDROs)

The rising prevalence of MDROs poses a serious challenge for the treatment of bacterial conjunctivitis. The widespread use of antibiotics, incorrect dosages, and inappropriate medications have contributed to this issue. Researchers are working on discovering efficient drugs to combat MDROs, but the non-availability of effective medications in the near future is likely to hamper market growth[1].

Strategic Alliances and Product Development

To counter these challenges, pharmaceutical companies are exploring product development partnerships (PDPs) with small biotech research organizations. These alliances can help share the high costs of research and development, potentially leading to the discovery of new and effective treatments for bacterial conjunctivitis, including those resistant to current antibiotics[1].

Key Takeaways

• Declining Market: The U.S. market for bacterial conjunctivitis drugs, including ZYMAXID, is declining due to genericization and patent expiries.
• Generic Competition: Generic versions of ZYMAXID and other topical fluoroquinolones are significantly impacting the revenue and market share of branded drugs.
• MDROs: The rise of multi-drug resistant organisms is a major challenge for the treatment of bacterial conjunctivitis.
• Strategic Alliances: Pharmaceutical companies are seeking strategic alliances to mitigate financial losses and develop new treatments.

FAQs

Q: What is ZYMAXID used for?

A: ZYMAXID, or gatifloxacin ophthalmic solution, is used to treat bacterial conjunctivitis.

Q: Why is the market for bacterial conjunctivitis drugs declining?

A: The market is declining due to the growing genericization of antibacterial drugs and the imminent patent expiries of top brands like ZYMAXID.

Q: How does the rise of MDROs affect the market for bacterial conjunctivitis drugs?

A: The rise of MDROs creates a serious challenge for the treatment of bacterial conjunctivitis, as current antibiotics may not be effective, leading to a need for new and efficient drugs.

Q: What strategies are pharmaceutical companies adopting to counter these challenges?

A: Pharmaceutical companies are adopting product development partnerships (PDPs) with small biotech research organizations to share the costs of research and development and discover new treatments.

Q: What is the expected financial impact on manufacturers of ZYMAXID?

A: The financial impact includes significant reductions in revenue and profitability due to generic competition and patent expiries.

Sources

1. Transparency Market Research - Bacterial Conjunctivitis Drugs Market Trends and Insight 2024
2. Zynex - Zynex Reports Fourth Quarter and Full Year 2023 Financial Results
3. Allergan - 2011 Allergan Annual Report
4. RxList - Zymaxid (Gatifloxacin Ophthalmic Solution): Side Effects, Uses ...
5. PR Newswire - Zynex Reports Second Quarter 2024 Financial Results