Monday, 31 May, 2010

Valacyclovir Hydrochloride (Valtrex) 500 mg and 1 g tablets: 8 generic players got final approval from USFDA

Following 8 generic players have obtained final approval to market generic version of Valacyclovir (Valtrex) 500 mg and 1 g tablets in US market:

1. Dr. Reddy's Laboratories
2. Mylan Pharmaceuticals Inc:
3. Matrix Laboratories Ltd.
4. Roxane Laboratories, Inc.
5. Sandoz Inc.,
6. Teva Pharmaceuticals USA:
8. Aurobindo Pharma USA, Inc:

The above generic players have obtained final approval from USFDA after the expiry of Ranbaxy's 180 days FTF exclusivity on May 25, 2010.

Please refer to my earlier post on Ranbaxy’s FTF exclusivity

Thursday, 20 May, 2010

Generic version of Atorvastatin Calcium tablets approved and launched in Canada

Various generic players have received the Notice of Compliance from Health Canada to market generic version of Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets in Canadian market.

The generic players like a) Apotex, b) Pharmascience, c) Teva, d) Sandoz, e) Watson, F) Cobalt, g) NovoPharm and h) Ratiopharm have received Notice of Compliance letters on this blockbuster formulation on May 19, 2009 (as per Health Canada website).

Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets had annual brand sales of approximately C$1.3 billion in Canada.

Innovator Pfizer has a key patent CA2021546 (Expiry: July 19, 2010), the said patent covers enantiomer of Atorvastatin as product. The various generic players have litigated with innovator on this patent and subsequently generic players settled with innovator (in Aug, 2008). As per press releases, 3 generic players namely Apotex, Teva and Watson have confirmed about the generic launch in the Canadian market. Importantly, these generic players have been able to enter into the Canadian market exactly 2 months before the blocking patent's expiry.

Further, generic players like Apotex, Teva and Watson have announced about the generic launch of this formulation in the following press releases:

Teva Press Release:

Watson Press Release:

News about Ranbaxy's generic version:

Reuters news on the generic launch: tp://

Wednesday, 5 May, 2010

Losartan Potassium (Cozaar) and Losartan +HCTZ (Hyzaar/Cozaar Plus): Interesting decisions in US and EU

The generic players for Angiotensin Receptor Blocker (ARB) medicine Losartan Potassium (Cozaar) and Losartan + Hydrochlorthiazide (Hyzaar/Cozaar Plus) in the last 8-9 months have witnessed various interesting decisions in the courts, patent offices and regulatory agencies of US and Europe.

In US, generic player Teva secured First To File (FTF) 180 days exclusivity by challenging innovator Merck’s patent US5608075 (Expiry: Sep 4, 2009), which covers various polymorphic forms of Losartan Potassium. After Teva's ANDA filing, innovator Merck filed patent delisting request to USFDA on '075 patent. However, Teva opposed this delisting and after a long legal battle with USFDA in the court, Teva got exclusivity on this product. Also, generic players Roxane and Apotex challenged USFDA decision of grant of FTF 180 day’s exclusivity to Teva. The decision of US court and regulatory agency USFDA's decision has interesting discussion on patent delisting, Medicare Modernization act and FTF exclusivity forfeiture events.

In EU, the patent on Losartan (Cozaar) was supposed to expire in Sep, 2009. However, the Paediatric extension to the Losartan Potassium (Cozaar) at the last moment (before SPC expiry) delayed the generic launch date of various generic players to March, 2010. Earlier, in Sep, 2009 there was uncertainty on Paediatric extension status in some EU countries including UK, where patent office first rejected Paediatric extension, however, higher court granted the Paediatric extension in UK.

Now, Kluverpatentblog ( has reported interesting case of Losartan +HCTZ (Hyzaar/Cozaar Plus) launch date issues in Belgium and France. The highlights of the issues are as follows:

1) EP 0253310 (Expiry: March, 2010): the patent covers Losartan as product. The patent has got SPC in major EU countries like Belgium and France, which expired on 2 September 2009. Also, innovator Merck got Paediatric extension of 6 months for monotherpay, which expired in March, 2010.

2) EP0733336 (Expiry: February 15, 2010): This patent covers combination of Losartan and diuretic like Hydrochlorthiazide as product. The patent has got SPC in major EU countries like Belgium and France, which expired on 15 February 2010.

The various generic players were ready to launch Cozaar plus after the expiry of ‘336 patent (as no Paediatric extension was granted to this patent). However, innovator Merck opposed generic version based on the argument that paediatric extension granted to ‘310 would also covers combination of Losartan with diuretic, so generic players can not launch generic version till March, 2010.

The President of the Brussels Commercial Court on February 12, 2010 sided with generic players and opined that paediatric extension will not be applicable to Cozaar Plus. Also, Brussels Court of Appeal on February 23, 2010 upheld the commercial court’s decision.

Conversely, in France, the court opined that Paediatric extension granted to Cozaar will also cover Cozaar plus.

Overall, the patent disputes, exclusivity disputes and Paediatric extension disputes on this molecule have provided clarity to various generic players for the future generic launches in EU and US. Also, the techno-legal discussions and facts on various issues will serve as a training material for IP professionals.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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