Tuesday, April 12, 2016

Letter Submitted to the Federal Trade Commission on the Inexplicably  High Price of Generic Modafinil Produced by Four Companies

        RE: Anomalous Higher Price of Generic Modafinil than Patented Metabolite, Nuvigil (Armodafinil)

Dear Madam or Sir:
Modafinil is a medication that effectively promotes wakefulness. It has found many uses on and off label. Its patent expired. Regulatory action took place after generic companies were paid to delay producing it, in the FTC’s Pay to Delay matter.  (https://www.ftc.gov/news-events/press-releases/2015/05/ftc-settlement-cephalon-pay-delay-case-ensures-12-billion-ill)

A metabolite (break down product), armodafinil, was patented, as Nuvigil. Its maker priced modafinil higher to promote the sales of Nuvigil. I understand the logic and their right to do so. Modafinil has longer action, and less of a crashing sleepiness effect than armodafinil. Thus, the longer half life of the original molecule, modafinil, may be more desirable to doctors and patients.

What I do not understand is why other companies making generic modafinil would also price it higher than Nuvigil, a product they do not make. Nuvigil (armodafinil) 150 mg has the same strength as Provigil (modafinil) 200 mg.

Prices for 30 pills (according to Giant Pharmacy, 9/21/15).

Modafinil 200 mg, by Par, Teva, Watson (Actavis), and Qualitest: all $1000.

Nuvigil 150 mg, (armodafinil): $670.

There appears to be a concerted effort to control the pricing of modafinil that violates the anti-trust laws.  Why would a competitor not price the perfectly equivalent, or even superior, modafinil a $1 less than Nuvigil and capture the large market for this medication?

Generic modafinil is also made in India. Its retail cost in a pharmacy in India  is 80 cents a pill. People who have taken it report it to be as good as the US medication. No doubt, maker and pharmacist are making a profit at that price.

I request an investigation into this anomalous pricing situation. The argument that these are different medications is specious. Modafinil is converted into armodafinil by the liver. 

I have standing to take the place of my patients in legal disputes (granted by the Third Circuit, in Behar v DOT)

Sincerely Yours,

David Behar, MD

Maker of Provigil and Nuvigil

Teva Pharmaceuticals
41 Moores Road
Frazer, PA 19355

Makers of Modafinil (generic Provigil)

Par

http://parpharm.com/

300 Tice Boulevard
Woodcliff Lake, NJ 07677
 (201) 802 4000

Teva

Teva North America
1090 Horsham Road
North Wales, PA 19454 USA
888-TEVA-USA (888-838-2872)

Watson (now Actavis)

 Morris Corporate Center III
 400 Interpace Parkway
 Parsippany, NJ 07054 USA

 862-261-7000
 Fax: +1-862-261-7914

Qualitest

3241 Woodpark Blvd
Charlotte, NC 28206
704-598-5011

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