Apotex in Pole Position for First Launch of Generic Zymar (Gatifloxacin)?

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GenericsWeb has recently published an article based on its proprietary Pipeline Patent Intelligence to reveal a number of patents that could further delay generic versions of Gatifloxacin beyond this year's expiry of the molecule patent.

GenericsWeb, the leader in pharmaceutical patent analysis and searching, has recently published an article based on its proprietary Pipeline Patent Intelligence to reveal a number of patents that could further delay generic versions of Gatifloxacin beyond this year's expiry of the molecule patent.

Zymar® (Gatifloxacin), marketed by Allergan, is indicated for the treatment of bacterial conjunctivitis and was ranked as the number two ophthalmic anti-infective prescribed by ophthalmologists in the US in 2008 (according to Verispan). Zymar® contains Gatifloxacin base and is sold as 0.3% ophthalmic solution/drops.

As expiry of the patent protecting the Gatifloxacin molecule (US4980470) looms in June this year, generic companies seeking to enter the US market are encouraged to obtain a complete understanding of the landscape surrounding the Zymar® product.

Of particular concern is the Orange book listed patent US6333045 protecting the marketed aqueous liquid formulation of Gatifloxacin and disodium edetate, which will not expire until 2020. In order to enter the market before the expiry of this patent, generic developers either need to invalidate this patent or find a way to formulate their version of the product using a different chelating agent. Apotex appears to have adopted the former approach, by counterclaiming that the US6333045 patent is invalid and unenforceable in response to Allergan's suit against them in 2009, which followed Apotex's submission of the ANDA with a Paragraph IV certification. If Apotex's challenge is successful they may benefit from a 180-day market exclusivity for their generic version of Zymar®, being the first filer for the ophthalmic drops dosage form with a paragraph IV certification.

"Although the Orange book lists only one patent related to formulation of the Zymar® product, analysis of the Pipeline Developer report reveals a number of patent families that could further delay generic versions of this drug," said Dae Oh, Senior Patent Analyst at GenericsWeb. "Patenting activity relating to this drug has focused on formulations, with almost half of the total 282 Gatifloxacin related patent families falling into this category, with an abrupt increase in the filing of formulation related applications by generic companies since the major launch in 2001."

"It is possible that Apotex will be the first generic company to enter the US market with their proactive approach to IP," said Leighton Howard, CEO at GenericsWeb. "Other generic developers still have an opportunity to enter the market with their own generic version of this product once any 180 day exclusivity period has expired, providing they too have done their homework in regards to finding a non-infringing formulation." Generic companies who have filed Drug Master files in the US include Cadila, Dr Reddy's, Teva, Matrix, Uquifa, Hetero, Ihara and Kyorin, although it is believed that many of these may not be suitable for the ophthalmic solution and were intended for use with the withdrawn oral tablet dosage form, sold under the Tequin brand.

You can read the entire article here: http://www.genericsweb.com/druginfocus/gatifloxacin/

About GenericsWeb - The Search is Over
GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

Pipeline Developer
Pipeline Developer, a professional patent database providing the very best in comprehensive patent information while minimising the risk of wasted developments or legal action. Searched and analysed by highly trained, dedicated staff using sophisticated searching techniques, Pipeline Developer delivers results you can rely on through a convenient online interface. For more information on Pipeline Developer visit http://www.genericsweb.com

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