[cubatex]

Revlimid - how long before it goes generic?

by cubatex on Sun Oct 16, 2011 2:46 am

I am new to this site but would like to share some information on Revlimid, a drug that a lot of us here rely on to survive. In 2008, I was diagnosed with multiple myeloma and took three cycles of Revlimid. Later that year, I had a stem cell transplant and was in full remission for two years before relapsing.

Not an usual circumstance. I have been on Revlimid since then, a 10 mg dose. Unfortunately, I work in Australia and being a US citizen, I am not covered by the Medicaid system here. I have to purchase Revlimid at $5,600 / cycle and then claim the refund with my insurance back in the US since they will not accept a claim from an Australian pharmacy. My battle.

However did you know that the patent on Revlimid was extended from 2016 to 2019? Go to the following link and scroll to the bottom.

http://www.uspto.gov/patents/resources/terms/156.jsp

You will see all the drugs, including Revlimid which were granted a patent extension. For those of us who need the drug and have to pay upfront, this is a blow. I thought I share this with the members here. It will be a long time before it goes generic and the more lives helped.

I wish all the multiple myeloma patients on the site all the best! Let's keep fighting multiple myeloma and the power of positive thinking will defeat it! Say it! Fight it! Cure it!

[sheba]

Re: Revlimid - how long before it goes generic?

by sheba on Mon Sep 15, 2014 6:10 am

There is already a generic that is being manufactured in India. It's called Lenalid.

I was able to ask my friend who went to India to buy it. The receipt I think was for $100 for the 5 mg bottle. I was also able to buy from a medical representative for $500-600.

Now whether the drug is as effective is another thing. Because my dad's US doctor mentioned that he expected my dad's blood count to drop after taking Revlimid which didn't happen when he was on Lenalid. So maybe the drug may not be as potent?

My dad did respond to Lenalid, but only very briefly.

[bailey]

Re: Revlimid - how long before it goes generic

by bailey on Tue Sep 16, 2014 4:38 am

If you are not responding to Lenalid (a generic of Revlimid manufactured in India), does that mean you will also not respond to Revlimid?

[NStewart]

Re: Revlimid - how long before it goes generic?

by NStewart on Tue Sep 16, 2014 1:37 pm

From what I understand, Revlimid will probably never go generic in the US. They have a copyright on the health questionnaire that we have to complete each month prior to receiving our new prescription of the drug. Because of this, Revlimid will continue to be name brand in the US.

If anyone knows any differently, please let us all know.

Nancy in Phila

[DallasGG]

Re: Revlimid - how long before it goes generic?

by DallasGG on Tue Sep 16, 2014 1:53 pm

I wouldn't say that Revlimid will never go generic in the US. But the date is currently up in the air according to the following 2 articles. The earliest it could go generic in the US is Oct. 2019.

http://cancer.emedtv.com/Revlimid/generic-revlimid.html

"You cannot buy a generic Revlimid (lenalidomide) product at this time, as the drug is pro­tected by patents and exclusivity rights that have not yet expired. After the first patent expires in October 2019, companies may decide to make a generic version of this medication. How­ever, new patents, lawsuits, or other circumstances may change the exact date of generic availability."

Another article discusses a company called Mylan who is or has sued Celgene to get access to Revlimid so it can start working on creating a generic version.

"Mylan sues Celgene for blocking Revlimid, Thalomid generics," Reuters, April 3, 2014

"In its lawsuit filed in the U.S. District Court in Newark, New Jersey, Mylan accused Celgene of using federal limits on the distribution of Revlimid and Thalomid, which were designed to pro­mote the drugs' safety, as a pretext to keep generic drug makers from obtaining their own sam­ples."

[Bar-none]

Re: Revlimid - how long before it goes generic?

by Bar-none on Thu Jan 28, 2016 9:37 pm

Hi All,

While not immediately helpful, a generic will be sold starting in ~6 years according to Celgene:

In December 2015, Celgene announced the settlement of litigations with Natco Pharma Ltd. and its partners and affiliates, relating to certain patents for Revlimid®. As part of the settlement, Celgene agreed to provide Natco with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the U.S. beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic lenalidomide in the U.S. commencing in March 2022, which is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the U.S. during the first year of entry. The volume limitation is expected to increase gradually each twelve months until March 2025. Natco's ability to market generic lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

Best! BN