AZASITE Drug Patent Profile

Which patents cover Azasite, and when can generic versions of Azasite launch?

Azasite is a drug marketed by Thea Pharma and is included in one NDA.

The generic ingredient in AZASITE is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azasite

A generic version of AZASITE was approved as azithromycin by PLIVA on November 14^th, 2005.

Summary for AZASITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	17
Patent Applications:	3,137
Drug Prices:	Drug price information for AZASITE
What excipients (inactive ingredients) are in AZASITE?	AZASITE excipients list
DailyMed Link:	AZASITE at DailyMed

See drug prices for AZASITE

Recent Clinical Trials for AZASITE

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

Sponsor	Phase
Thomas Jefferson University	Phase 2
Merck Sharp & Dohme Corp.	Phase 2
Philadelphia Eye Associates	Phase 2

See all AZASITE clinical trials

Pharmacology for AZASITE

Drug Class

Macrolide Antimicrobial

Paragraph IV (Patent) Challenges for AZASITE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZASITE	Ophthalmic Solution	azithromycin	1%	050810	1	2011-03-03

US Patents and Regulatory Information for AZASITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes

Expired US Patents for AZASITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007

International Patents for AZASITE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2001521885
New Zealand	238850	SUSTAINED-RELEASE GEL FOR DRY EYES CONTAINING MICROPARTICLES OF AN ETHER-CROSS-LINKED POLYMER HAVING CARBOSCYL GROUPS AND A DEMULCENT AND/OR VASOCONSTRICTOR
Morocco	22756
Greece	3030381
Spain	2134769
Denmark	1165058
New Zealand	235903	TISSUE MOISTURISING COMPOSITION COMPRISING A BIOADHESIVE MOISTURISING POLYMER WHICH IS WATER-SWELLABLE, WATER-INSOLUBLE AND IS CROSS-LINKED CARBOXY-FUNCTIONAL; TREATMENT OF BODY TISSUES

AZASITE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AzaSite

Introduction

AzaSite, an azithromycin ophthalmic solution, has been a significant player in the ophthalmic therapeutics market, particularly for the treatment of bacterial conjunctivitis. Developed by InSite Vision and marketed by various partners, AzaSite has navigated a complex market landscape with notable successes and challenges.

Market Approval and Launch

AzaSite received FDA approval in 2007 for the treatment of bacterial conjunctivitis, marking a significant milestone in its commercial journey. Inspire Pharmaceuticals, which licensed the rights from InSite Vision, launched AzaSite in the US and Canada, anticipating substantial revenue growth. The product was expected to generate $30 to $45 million in sales in 2008, reflecting its potential in the market[5].

Drug Delivery Technology

A key factor in AzaSite's success is its use of the DuraSite drug delivery system. This technology allows the antibiotic to stay on the surface of the eye longer than conventional eye drops, reducing the need for frequent dosing. This innovation has been crucial in differentiating AzaSite from other treatments, making it a preferred option for patients and healthcare providers[4].

Market Performance

The financial performance of AzaSite has been robust, driven by its unique delivery system and effective treatment of bacterial conjunctivitis. In the first quarter of 2011, AzaSite net sales grew by 26% compared to the same period in 2010, contributing to an increase in royalty revenues for InSite Vision. This growth was a result of increased prescriptions and sales, indicating strong market acceptance[2].

Licensing and Partnerships

InSite Vision has strategically partnered with other companies to expand AzaSite's reach. For instance, in 2015, InSite Vision entered into a license agreement with Nicox S.A. for the development and commercialization of AzaSite, AzaSite Xtra, and BromSite in Europe, the Middle East, and Africa. This agreement included an upfront payment of $3 million and potential milestone payments of up to $13.75 million, along with royalties, highlighting the market potential of these products[1].

Competitive Landscape

The ophthalmic therapeutics market is highly competitive, with several major players. AzaSite competes with other antibiotic eye drops like Besivance (besifloxacin ophthalmic suspension) marketed by Bausch & Lomb. However, AzaSite's unique delivery system and fewer dosing requirements have helped it maintain a competitive edge[2][4].

Financial Trajectory

Revenue Growth

The revenue from AzaSite has been a significant contributor to InSite Vision's financial health. In the first quarter of 2011, royalty revenues from AzaSite and other products increased to $2.9 million, up from $2.2 million in the same period of 2010. This growth was largely driven by the 26% increase in AzaSite net sales[2].

Expenses and Net Loss

Despite the revenue growth, InSite Vision reported a net loss in the first quarter of 2011, primarily due to research and development expenses and general and administrative costs. The net loss was $2.4 million, or $0.03 per share, which was an improvement from the $2.9 million net loss in the first quarter of 2010[2].

Cash and Investments

As of March 31, 2011, InSite Vision had cash, cash equivalents, and short-term investments of $13.8 million, providing a stable financial foundation for ongoing operations and future developments[2].

Future Outlook

Market Expansion

The licensing agreement with Nicox S.A. is expected to expand AzaSite's market presence in Europe, the Middle East, and Africa. Nicox plans to file European Marketing Authorizations for AzaSite and BromSite, with commercial launches anticipated in late 2017. This expansion targets a market estimated to be over $337 million[1].

Product Pipeline

InSite Vision is also advancing other ophthalmic therapeutics, including AzaSite Plus, which is in Phase 3 clinical studies for the treatment of eye infections, and DexaSite for the treatment of blepharitis. These pipeline products are expected to further bolster the company's financial trajectory and market position[1][4].

Key Takeaways

• Innovative Drug Delivery: AzaSite's use of the DuraSite drug delivery system has been a key differentiator, allowing for fewer doses and longer retention on the eye surface.
• Strong Market Performance: AzaSite has shown significant revenue growth, driven by its effectiveness and market acceptance.
• Strategic Partnerships: Licensing agreements, such as the one with Nicox S.A., have expanded AzaSite's market reach and potential.
• Competitive Edge: Despite competition, AzaSite's unique delivery system has maintained its competitive position in the ophthalmic therapeutics market.
• Future Growth: Ongoing product development and market expansion are expected to contribute to continued financial growth.

FAQs

What is AzaSite used for?

AzaSite is used for the treatment of bacterial conjunctivitis, commonly known as "pink eye."

Who markets AzaSite in the US?

AzaSite is marketed in the US by Akorn, Inc., although it was initially licensed to Inspire Pharmaceuticals for commercialization[1][4].

What is the DuraSite drug delivery system?

The DuraSite drug delivery system is a patented technology that allows the antibiotic to stay on the surface of the eye longer, reducing the need for frequent dosing[4].

How has AzaSite performed financially?

AzaSite has contributed significantly to InSite Vision's revenue, with a 26% growth in net sales in the first quarter of 2011 compared to the same period in 2010[2].

What are the future market expansion plans for AzaSite?

AzaSite is set to be commercialized in Europe, the Middle East, and Africa through a licensing agreement with Nicox S.A., with expected commercial launches in late 2017[1].

Sources

1. InSite Vision Announces License Agreement For Azasite ... - BioSpace
2. InSite Vision Reports First Quarter 2011 Financial Results
3. Azithromycin Market Insights, Future Trends, On-going Demand ... - Reports and Data
4. Drug delivery keeps eye on the market - Outsourcing-Pharma.com
5. Inspire Pharmaceuticals, Inc. Announces FDA Approval Of AzaSite ... - BioSpace