Atorvastatin+Amlodipine (Caudet): Ranbaxy launched authorized generic

The generic player Ranbaxy has launched the authorized generic version of Amlodipine+ Atorvastatin (Caudet) tablets in US market. This was confirmed by the generic pharma giant in following press release: http://www.ranbaxy.com/news/newsdisp.aspx?cp=988&flag=LN

Innovator Pfizer is currently marketing about 11 combination strenghts in US market (Amlodipine+Atorvastatin):

10+10, 10+20, 10+40, 10+80, 2.5+10, 2.5+20, 2.5+40, 5+10, 5+20, 5+40, 5+80 mg tablets

This launch was as per Ranbaxy's earlier settlement with innovator Pfizer. Earlier, Ranbaxy has challenged the innovator's combination patent on this combination US6455574, scheduled to expire on Aug 11, 2018.

Atorvastatin: Authorized generic arrived, Ranbaxy generic approved with help from Teva

The historic day for American public to welcome generic version of Blockbuster drug Atorvastatin hemicalcium tablets (Lipitor). In India, every person working in the Pharma industry was eagerly awaiting news about generic approval and launch by Ranbaxy. However, it was not clear that Ranbaxy would be able to launch the generic version till Nov 30 evening. However, Dec 1 morning in India bring good news for Ranbaxy and it was confirmed that Ranbaxy has been able to resolve the cGMP issues raised by USFDA against Ranbaxy's API and formulation manufacturing units located in India. The various news items confirmed that Ranbaxy has been able to get the approval from it's US subsidiary M/S Ohm lab. Earlier, some FTF products of Ranbaxy like Donepezil and Valacyclovir were launched from this facility only.

Launch with help from Teva: As per Ranbaxy's official press release the part of sale shall be shared with Teva which probably has helped Ranbaxy on resolving various technical issues with USFDA.
http://www.ranbaxy.com/news/newsdisp.aspx?cp=987&flag=LN

Other generic players: Earlier, the generic players like Actavis, Teva, Dr Reddy, Aurbindo, Mylan and few others have settled the patent litigation with innovator on crystalline form I patent and these companies have been eagerly awaiting the generic launch of Ranbaxy to subsequently launch their generic version after the expiry of 180 days exclusivity of Ranbaxy. These companies are expected to launch the generic version in first week of June, 2012.

Overall, this is a very good news for all the scientists of Ranbaxy who were instrumental in developing the generic version. As the Para IV filing was made about 8-10 years ago and some of those scientists may have been working in other organisations now. However, they will be very happy on this news and must be silently admiring this news.

Overall, a good finish in the end like a bollywood thriller.

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

Donepezil (Aricept): 16 generic players got final approval after FTF expiry

About 16 players got final approval on Donepezil Hydrochloride 5 and 10 mg tablets for US market. Earlier, the First para IV filer Ranbaxy got final approval on Nov 26, 2010 after the expiry of compound patent.

After the FTF expiry on May 30, 2011, the USFDA approved generic version of this medication on May 31, 2011
1) Teva
2) Cipla
3) Mutual
4) Roxane
5) Aurbindo
6) Hikma
7) Sandoz
8) Pliva
9) Sun
10) Matrix
11) Actavis
12) Torrent
13) Jubilant
14) Wockhardt
15) Huahai
16) Dr Reddy

The sale of this molecule is about 3 billion USD.

IP Pharma Doc congratulate all the above players.