Valacyclovir Hydrochloride (Valtrex) 500 mg and 1 g tablets: Ranbaxy Launched Generic Version

Generic pharma giant Ranbaxy has launched generic version of Valacyclovir hydrochloride (Valtrex) 500 mg and 1 g tablets in USA on November 25, 2009.

Earlier, Ranbaxy was the first company who challenged innovator Glaxosmithkline (GSK) following Orange Book listed patent:

US4957924 (Expiry: Dec 23, 2009): Which covers Valacyclovir as product.

Subsequently, innovator sued Ranbaxy in New Jersey District Court in 2003. Afterwards, Ranbaxy got final approval from USFDA for this product on January 31, 2007 .

Further, as per paragraph IV patent litigation settlement agreement in July, 2007 with innovator Glaxosmithkline (GSK), Ranbaxy agreed to enter into the market in later half of 2009. Also, Ranbaxy entered into licensing agreement with innovator on two Orange Book listed patents US5879706 and US6107302 (both patents would expire on Jul 19, 2016), which covers polymorph and formulation of Valacyclovir.

Importantly, Ranbaxy is first Para IV filer for this product; accordingly, Ranbaxy would enjoy financially rewarding 180 days “First To File” market exclusivity.

Ranbaxy has manufactured the Valacyclovir hydrochloride 500 mg and 1 g tablets from it’s New Jersey based subsidiary Ohm Laboratories.

The other generic players who have received tentative approval from USFDA for this product are Dr. Reddy (June 26, 2009), Sandoz (July 30, 2007), Teva (October 4, 2007), Mylan (January 30, 2007), Watson (January 18, 2007). The other generic players would be able to launch their generic version after the expiry of 180 days exclusivity of Ranbaxy.

Valacyclovir tablets (Valtrex) 500 mg and 1 g were approved by USFDA on Jun 23, 1995 and are indicated for the treatment of herpes zoster, treatment of genital herpes, treatment of cold sores, and suppression of genital herpes in immunocopetent and HIV-infected individuals, reduction of risk of heterosexual transmission of genital herpes.

As per investment research firm IMS, the annual USA sales for Valacyclovir tablets 500 mg and 1 g is about 2.2 billion dollars.

Related news:
http://www.advfn.com/news_UPDATE-Ranbaxy-Launches-Generic-Valtrex-In-US-Shares-Rise_40540383.html

http://topnews.net.nz/content/21068-ranbaxy-introduces-glaxos-valacyclovir-american-market

Fluocinonide (Vanos cream) and Ciclopirox Olamine (Loprox gel): Glenmark settled patent litigation with innovator

Generic player Glenmark announced (in a press release Here ) the Paragraph IV patent litigation settlement with innovator Medicis Pharmaceutical on Fluocinonide (Vanos) cream and Ciclopirox Olamine (Loprox) gel topical formulations.

Fluocinonide (Vanos) 0.10% cream
Earlier, innovator Medicis sued Glenmark in New Jersey District Court in June, 2009 for the infringement of following Orange Book listed patents on Fluocinonide (Vanos ) 0.10% cream:

US6765001 (Assignee: Medicis Pharmaceutical; Date of Grant: July 20, 2004; Expiry Dec 21, 2021): Which covers a composition comprising One or more corticosteroids, wherein one corticosteroid comprises fluocinonide; Two or more penetration enhancers selected from the group consisting of diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexapetriol, and benzyl alcohol; and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in a ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90.

US7220424 (Assignee: Medicis Pharmaceutical; Date of Grant: May 22, 2007; Expiry: Jan 7, 2023): which covers a method of delivering corticosteroids to skin comprising: Topically applying a composition comprising one or more corticosteroids with two or more penetration enhancers, and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90, and wherein the penetration enhancers comprise two or more of the group consisting of propylene glycol, diisopropyl adipate, dimethyl isosorbide, 1,2,6 hexanetriol, and benzyl alcohol

Under the terms of the Settlement Agreement, Glenmark will be able to market and distribute its generic version of Fluocinonide (Vanos cream) under license from Medicis as early as December 2013, or earlier in certain circumstances

Ciclopirox Olamine (Loprox) 0.77% Gel
Earlier, innovator Medicis sued Glenmark in New Jersey District Court for the infringement of following Orange Book listed patents on Ciclopirox Olamine (Loprox) 0.77% Gel:

US7018656 (Assignee: Aventis Pharma Deutschland ; Date of Grant: March 28, 2006; Expiry: Sep 5, 2018): which covers a gel composition comprising: at least one compound chosen from 1-hydroxy-4-methyl-6-cyclohexyl-2(1H)pyridone and physiologically tolerable salts thereof; polyacrylic acid polymer; sodium dioctylsulfosuccinate; and 2-octyldodecanol; wherein the composition is not an emulsion.

As per terms of settlement, Glenmark will have a license to launch a generic version of Ciclopirox Olamine (Loprox) 0.77% gel, supplied by Medicis immediately.

Also, Glenmark announced (in a press release Here ) that it has entered into an agreement with pharma giant Medicis Pharmaceuticals for co-development of dosage forms for the treatment of acne vulgaris.