Bioequivalence study cost

[philly]

I am interested in the cost of bioequivalence study (BE) regarding a hybrid medicinal product (oral solid dosage form, modified-release). Does anyone here have any idea of how much could it cost? How does it compare to the cost of BE study of a product being a simple, single-ingredient tablet?

[bobbin]

Probably wouldn't cost too much because the number of subjects is normally quite small.

[philly]

I have been told in another forum that it starts at 100k EUR. Let's add another 100-150k of registration costs and another 100k of costs like marketing etc. How come the generics manufacturers manage to make a profit?

[bobbin]

I have been told in another forum that it starts at 100k EUR. Let's add another 100-150k of registration costs and another 100k of costs like marketing etc. How come the generics manufacturers manage to make a profit?

The large generics manufacturers have staff who specialise in getting new products registered. I suppose it's easier when you've done it 100 times before.

Mass produced pharmaceuticals can be manufactured very cheaply. Some generics are much more profitable that others because prices are controlled by the amount of competition eg.

Hydrocortisone 10mg tablet (30) sell for about £44 (no competition)
Cetirizine 10mg tablets (30) sell for about 24p (intense competition)

Major manufacturers such as TEVA have some very profitable products (eg. phenytoin tabs) and some that will make very little (eg. amiloride tabs). I assume that the high margin products subsidise the low margin products in their portfolio.

[philly]

Now, the question is why is there no competition in case of certain products, which are not protected by a patent, such as phenytoin sodium or hydrocortisone tablets?

[bobbin]

Now, the question is why is there no competition in case of certain products, which are not protected by a patent, such as phenytoin sodium or hydrocortisone tablets?

No competition at the moment, but there probably will be within the next few years. The prices will then go down. Generics prices go up and down all the time, sometimes dramatically. In the past, there were several manufacturers of phenytoin tablets.... and it was very cheap.

[johnep]

All to do with supply and demand. MSD had a branded Hydrocortisone tablet which was relatively cheap. Pharma constantly scrutinises it's product list and uneconomic products are culled. They do not want to raise the price to an economic level because of:
1) PPRS scheme. Very great difficulty for an established product to get a price rise.
2)Adverse publicity. Better by far to distance themselves by letting someone else raise the price.

If a product sustains a high price, then competition will come in. If a product is in a market where hardly any profit, then get out and use the machinery for something more profitable.
johnep