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.

Lansoprazole (Prevacid) ODT tablets: Teva Receives Favorable Court Decision; Innovator appeled in CAFC

Innovator Takeda has appealed against the U.S. District Court for the District of Delaware decision, wherein, court found no infringement by Teva in a patent dispute on Lansoprazole (Prevacid) ODT tablets.

Earlier, generic player Teva Pharma announced (in a press release Here ) that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab.

The Court found that Teva's generic Lansoprazole orally disintegrating tablets do not infringe the following disputed patent:

US5464632 (Assignee: Laboratoires Prographarm ; Date of Filing: November 29, 1994; Date of expiry: May 7, 2013) The patent covers a rapidly disintegratable tablet for oral administration with or without the use of water, said tablet comprising an active substance and a mixture of excipients, wherein said active substance is multiparticulate and in the form of coated microcrystals, coated microgranules or uncoated microgranules and wherein said mixture of excipients comprises excipients which are responsible for the disintegration, said tablet being intended to be swallowed said disintegration occurring in less than sixty seconds under the action of the excipients which are responsible for the disintegration and which are selected from the group consisting at least one disintegrating agent and at least one swelling agent.

To overcome above claim, Teva used Starlac (a coprocessed excipients with 85% of Lactose and 15% of corn starch). The generic company and innovator provided testimony in the court w.r.t mechanism of disintegration of Starlac, however, opposing party could not prove convincingly that either lactose or corn starch was responsible for the rapid disintegration of generic product. In the light of above findings, court concluded that Teva’s generic version would not be covered under the scope of ‘632 patent.

As per press release, Teva intends to complete an analysis of the decision before deciding upon its next course of action.

Annual sales of the brand product were approximately $500 million in the United States for the twelve months that ended June 30, 2009 based on IMS sales data.

New Paragraph IV certifications reported by USFDA From Oct, 2009 to 5th November, 2009

1) Diclofenac Sodium and Misoprostol (Arthrotec) 50 mg + 0.2 mg DR Tablets : Paragraph IV filed on June 29, 2009

2) Fluvoxamine Maleate 100 mg Capsules (Luvox CR) 5 mg ad 10 mg Tablets: Para IV filed on April 20, 2009

3) Glycopyrrolate (Robinul Forte) 1.5 mg Tablets : Para IV filed on May 6, 2009

4) Vardenafil (Levitra) 5 mg ad 10 mg Tablets: Para IV filed on July 10, 2009

5) Amoxicillin and Clavulanate Potassium (Augmentin XR) 1000 mg + 62.5 mg ER tablets : Para IV filed on Jan 21, 2009

6) Armodafinil (Nuvigil) 50 mg, 150 mg and 250 mg: Para IV filed on July 24, 2009; for the other stregths like 100 mg and 200 mg, Para IV filed on Sep 11, 2009

7) Atazanavir Sulfate (Reyataz) 300 mg Capsules: Para IV filed on July 20, 2009

8) Caspofungin Acetate (Cancidas) 50 mg and 70 mg vial for injection: Para IV filed on June 26, 2009

9) Cisatracurium Besylate (Nimbex) 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial: Para IV filed on Aug 4, 2009; 2 mg/mL, 10 mL vial Para IV filed on Aug 12, 2009

10) Ezetimibe and Simvastatin (Vytorin) 10 mg + 10 mg, 10 mg + 20 mg, 10 mg + 40 mg and 10 mg + 80 mg Tablets: Para IV filed on July 27, 2009

11) Olopatadine Hydrochloride (Patanase) 0.665 mg/Spray (Nasal Spray): Para IV filed on June 29, 2009

12) Metformin Hydrochloride (Glumetza) 500 mg and 1000 mg ER tablets: Para IV filed on July 27, 2009

13) Mometasone Furoate (Nasonex ) 50 mcg/nasal spray: Para IV filed on Aug 7, 2009

14) Morphine Sulfate (Avinza) 45 mg and 75 mg ER capsules: Para IV filed on July 30, 2009

15) Ramelteon 8 mg Tablets (Rozerem): Para IV filed on July 22, 2009

16) Sibutramine Hydrochloride (Meridia) 10 mg and 15 mg: Para IV filed on Aug 14, 2009

17) Tigecycline (Tygacil) For Injection 50 mg per vial: Para IV filed on June 15, 2009

18) Tobramycin (Tobi) 300 mg/5 ml Inhalation Solution: Para IV filed on June 29, 2009

19) Linezolid (Zyvox) 100 mg/5 ml Oral Suspension: Para IV filed on Aug 3, 2009

Source: USFDA Para IV list Here

Ramelteon (Rozerem) 8 mg Tablets: Innovator Takeda Sues Teva

In an attempt to block generic version of Ramelteon (Rozerem) 8 mg Tablets, innovator Takeda has filed an infringement action against generic player Teva pharma in U.S. District Court for the District of Delaware.

Innovator has listed following patent in the Orange Book for this product:

US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as product

The generic player Teva has challenged the said patent on various patent invalidation grounds.

Earlier, innovator got approval to market Ramelteon (Rozerem) 8 mg Tablets on Jul 22, 2005.

Recent press releases: Brimonidine tartrate, Fenofibrate, Glatiramer acetate, Lansoprazole

Brimonidine tartrate ophthalmic solution 0.1% and 0.15% (ALPHAGAN): Innovator announced favorable decision by US court

Innovator Allergan announced (in a press release Here ) that the United States District Court for the District of Delaware has ruled in favor of Allergan on key patents covering Brimonidine tartrate ophthalmic solution 0.1% and 0.15% (ALPHAGAN). The court has upheld the validity of key patents US6627210; US6641834; US6673337; US6562873; and US5424078

Fenofibrate (Tricor) 48 mg and 145 mg Tablets: Impax Laboratories Confirms Patent Challenge

Generic player Impax Laboratories confirmed ( in a press release Here) that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with Fenofibrate (Tricor) 48 mg and 145 mg Tablets.

Glatiramer acetate injection (Copaxone):Teva asserts 3 more patents against generic players Monenta/Sandoz

Innovator Teva Pharma announced (in a press release Here) it is seeking to amend its existing complaint against Momenta Pharmaceuticals, Inc./Sandoz Inc. to include patent infringement of three additional patents related to the characterization of Glatiramer acetate injection (Copaxone). The proposed updated complaint has been filed under seal with the U.S. District Court for the Southern District of New York along with a motion requesting that the Court grant Teva leave to amend.

Lansoprazole (Prevacid) Delayed-Release Capsules 15 mg and 30 mg: Teva got final approval
Generic player Teva Pharma announced (in a press release Here) today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Lansoprazole (Prevacid) Delayed-Release Capsules 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009. Annual sales of Prevacid® Delayed-Release Capsules were approximately $2.97 billion in the United States for the twelve months that ended June 30, 2009 based on IMS sales data