Possible Generic Risperidone

[HA]

Ranbaxy Receives Tentative Approval to Market Risperidone Oral Solution
Friday August 4, 9:30 am ET

PRINCETON, N.J., Aug. 4 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Risperidone Oral Solution, 1 mg/mL.

Risperidone Oral Solution is indicated for the treatment of schizophrenia. Total annual market sales for risperidone oral solution were $66 million (IMS - MAT: March 2006).

"We are pleased to receive this tentative approval for Risperidone Oral Solution. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.....

My comments here:
Risperidone is the only atypical medication which has been recently developed into an injectable form. For many in Canada this form of Risperidone is still too expensive to be able to access.

 

[David Baxter PhD]

For many in Canada this form of Risperidone is still too expensive to be able to access.

That's true, although most people diagnosed with schizophrenia, with adequate documentation from their physician or other mental health professionals, should qualify for provincial disability status (e.g., Ontario Disability), which includes a drug card - then an average monthly prescription would cost only about $2.00.

 

[HA]

I'm not sure how this works but if anyone can point me to some links where I can get information about this, I'd really appreciate it.

I'm also not sure if this is still the case today but it has been my experience that for anyone with schizophrenia to be able to have an atypical (the newer drugs such as Seroquel, Olanzapine etc.) you had to first be tried on two of the older typical medications before being allowed to have the newer drugs. I'm thinking that this may be a similar case with restrictions for Risperdal Consta. I would really like to know how this works. Below is a section on this topic from the SSO site:

http://www.schizophrenia.on.ca/advocacywins
Access to Medications
When atypical medications were approved in the early 1990?s but not listed on the Ontario Drug Benefit Formulary, SSO fought to have these medications placed on the formulary.

More recently we successfully lobbied to have Risperdal Consta the first atypical injectable medication available in Canada listed on the Formulary. In April 2005, Risperdal Consta was made available through a Section 8 provision. This means that a patient?s psychiatrist can apply to have the costs of the medication reimbursed for their clients.

Currently, Ontarians have access to all medications indicated for schizophrenia. As the Ontario government may be reviewing this open access, we are working to ensure all medications continue to be included on the provincial formulary.

 

[David Baxter PhD]

I'm also not sure if this is still the case today but it has been my experience that for anyone with schizophrenia to be able to have an atypical (the newer drugs such as Seroquel, Olanzapine etc.) you had to first be tried on two of the older typical medications before being allowed to have the newer drugs. I'm thinking that this may be a similar case with restrictions for Risperdal Consta.

I don't know about the injectable, HeartArt, but I do know of a young man who recently qualified for Onatrio Disability and has one of the newer antipsychotics covered - this is his 2nd medication but both were in the new "atypical antipsychotic" family, so he was not required to first try one of the older medications.

I do believe there is a move in the states to try to cut Medicaid costs by shifting patients to the older (and cheaper) antispychotics - beginning with a campaign disputing that the newer ones are better or have fewer side-effects. It will be worth watching what happens south of the border since it may well have some longer term implications for Canada.

 

[ThatLady]

The insurance companies AND medicare are on the kick of trying to convince doctors that they shouldn't prescribe the newer, more expensive medications. Doctors are getting around it by ordering a very small number of one of the older, less expensive medications for their patient, then informing the insurance company/medicare that the medication is causing the patient problems and throwing a major MD hissy fit (a hissy fit to be reckoned with, believe me) until the insurance company/medicare buckles and pays for what the patient needed in the first place.

 

[David Baxter PhD]

Good to hear, TL. I must say that the tactics of many (most?) insurance companies when it comes to mental health issues is one thing that makes my blood boil.

 

[ThatLady]

Insurance companies, in general, make my blood boil! However, I've gotta say, this isn't directed only toward drugs used for the treatment of mental illness. This targets any and all drugs, regardless of the condition being treated. If the insurance company/medicare thinks they might be able to save a farthing, they're gonna insist you try a cheap alternative first. I don't blame the doctors one bit for finding a work-around to allow them to treat their patients with the best possible medication.