Published: Friday, Jan 4, 2013, 3:55 IST
By KV Ramana | Place: Hyderabad | Agency: DNA
Pharma major Dr Reddy’s Laboratories has embarked on yet another 180-day exclusivity opportunity with the launch of its Finasteride tablets in the US market.
Finasteride, which is marketed by a Merck subsidiary under Propecia brand, had an estimated $136 million sales for 12 months ended October 2012. Dr Reddy’s would market the 1 mg tablets in the bottle counts of 30 and 90.
Under the exclusivity, Dr Reddy’s would be the only company other than the innovator to market the drug for six months in the US.
However, analysts are wary of the price erosion on introduction of the generic drug.
Finasteride is indicated for the treatment of benign prostatic hyperplasia and male pattern baldness.
Meantime, the company is expected to receive approvals for yet another limited competition drug – azacitidine (brandname Vidaza) — in the US market this quarter.
“Azacitidine brand size is $340 million and both patent and marketing exclusivity have expired. Dr Reddy’s filed DMF (drug master file) in February 2010 and could get approval any time,” wrote Anubhav Aggarwal and Chunky Shah, analysts with Credit Suisse on Thursday.
At 50% price erosion and a 50% market share, Azacitidine could be a $65 million opportunity for Dr Reddy’s and competition is likely to remain limited before Teva enters after two years, they said.
Analysts also expect another drug Metoprolol to start contributing significantly to the revenue. “Higher Metoprolol sales should start in the middle of this quarter. We expect $60 million annualised contribution with margins of about 90%,” the Credit Suisse analyst said.
Deb, remember the posting. Don't see where it talks about Dacogen. I see where it talks about them producing a generic version of Vidaza but not Dacogen. Appears they filed for the generic of Vidaza in Feb 2010 but are still waiting on approval. Amazing how fast the generic version of Dacogen appears to be coming vs Vidaza.
I spent the past half hour looking on the FDA's website. They have a generic approval and tentative approval on their site. I was looking through for anything on dacogen and vidaza. I don't see any approvals for a generic drug. If you have time google FDA heneric approvals. It was the first site in the list. They have to update it, the last time was Jan3. You can go deeper into the site and look at tentative approvals for generics. They have to get approval from the FDA at some point.
I'm surprised the street is taking the dacogen generic news so well. Specially with it flirting with $3. They mention Buckmans name in the Q&A yesterday, but no one asked him a single question. The main questions was about SGI-110 and the three areas it could seek approval. The analyst ask a question about Registration stategy, maybe someone knows what that's about.
Here are the 3 options on SGI-110
Untreated int/high MDS
Relaspe AML(5 responders were from this group)
Dacogen both got approved on Responce rate. Later Vidaza on Survival.
The key yesterday is they will announce by EOY the pathway. I think $57M in Dacogen sales in the EU is a great start. They have 18,000 AML pts and 10,000 that qualify for dacogen.