Atorvastatin (Lipitor): The action begins in various markets

The richest molecule Atorvastatin is approching patent expiry in regulated market in US and EU and as the D-day is approching there has been new twists in activities by generic or innovator companies. The recent press releases have started disclosing their plans:
1. Innovator Pfizer revealed that they intend to make OTC switch.

2. Merck filed NDA on Ezetimibe+ Atorvastatin with USFDA. Although, Merck filed ANDA with amorphous form, innovator Pfizer promptly sued Merck for the infringement of crystalline polymorph patent scheduled to expire in Jan, 2017

3. To snub various generic companies, innovator Pfizer has asserted the polymorph patent against Mylan, Aurbindo, DRL and very recently against Macleods.

3. Lupin has alreday filed a suitability petition with USFDA for capsule version.

4. Cobalt prepared the strategy with sodium salt

5. The Teva is litigating in Europe for an early entry.

6. The Atorvastatin geneeric market first opened up in Canada and captured by around 8-10 players

7. The major bottleneck for the generic companies in US is Ranbaxy's FTF exclusivity and launch is expected by Nov 30, 2011. However, due to the regulatory problems of Ranbaxy there has been various speculations like Ranbaxy will delay the generic launch or they may share exclusivity with other player. The various generic players like Apotex and Mylan has been trying to trigger Ranbaxy's exclusivity without any success till date.

8. The Watson Pharma will launch an authorized generic verssion during Ranbaxy's FTF exclusivity.

9. The other players like Mylan, Kremer Urban, Apotex, Aurbindo, DRL and Macleods can be the other potrential player expected to launch in first week of June, 2012

Overall, IP Pharma Doc expect many more turns in events and will keep on updating the same on this blog