Plaquenil / hydroxychloroquine shortage update and a question

Hi all -

There's been talk on several of the HU boards regarding the shortage of Plaquenil and hydroxychloroquine. Since I've only been able to tolerate the name brand (generics cause me stomach/GI issues), I was concerned to hear this so I spoke with my pharmacist and also did some research. (The two generics I have tried are by Ranbaxy and Prasco Labs - I cannot tolerate either).

It's important to note that I am in the United States.

Here's some history:

On April 4, 2013, Covis Pharma (a Swiss-based company) acquired full commercial rights for Plaquenil (and 4 other products) in the United States from Sanofi. Sanofi retained the existing rights for Plaquenil in countries outside the United States. Covis is the manufacturer of the name brand Plaquenil tablets I have been taking for about a year with no issues.

In April 2015, Concordia acquired Plaquenil from Covis (this is the manufacturer of the Plaquenil tablets I have been taking and have no issues with). The ASHP (American Society of Health-System Pharmacists) reported a shortage of certain generics manufactured by Ranbaxy and Sandoz. No shortage in the U.S. for the name brand or other generics.

I went onto the Concordia website and they list Hydroxychloroquine Zentiva as the generic for their name brand. I took this information to my pharmacist to day with the hope they could order THIS SPECIFIC generic for me to try. If I can tolerate it, my medication costs would be significantly lower. The pharmacist didn't see it listed for her to order, but she was going to look into it and get back to me.

QUESTION: are there any folks, in the U.S. or otherwise, who have tried the Zentiva generic? Does it work for you (when other generics did not)? Anyone in the U.S. been able to get the Zentiva generic?

Thanks!

p.s. I've crossposted this information across several boards so everyone gets the information.

12 Replies

oldestnewest
  • Hi, thanks there are several posts on here regarding this, some from me, and also other references from patients, I will add this again: This is from Hughes Syndrome Foundation Website and charity web pages:

    We understand that many patients who take hydroxychloroquine under the trade name of Plaquenil have been told by their pharmacist that it has been 'discontinued'.

    The charity, Lupus UK, have carried out some research and issued the following statement:

    After speaking with Sanofi-Aventis Medicine's Information Department (the manufacturers of Plaquenil) we have learned that Plaquenil has now been 'de-branded' to generic but that the same formulation of the drug will be available through pharmacies if they order Hydroxychloroquine through Zentiva (the sister company to Sanofi).

    If your pharmacist has any difficulty obtaining the Hydroxycloroquine with the same formula from Zentiva the product descriptions is: "HYDROXYCHLOROQUINE SULPHATE (ZENTIVA) 200MG FILM COATED" and the 'PIP number' (Product Code) is 1201730.

    If for any reason they cannot find the product on their system they can ring the customer service line on 01483 505515.

    MaryF

  • Hi Mary -

    Yes, I have read your posts on this (thanks so much!! :-) ) I simply wanted to get additional info out there since I know other U.S. folks are on this site.

    I printed out the information and have given it to my pharmacist. She is researching it. I'm aware the names may be different here in the states. (I'm also not sure if the PIP number is universal or not).

    I'm actually a little worried that the generic "equivalent" in the U.S. to the Zentiva tablet just might be the Prasco Labs generic that I recently tried (pills look IDENTICAL to the Plaquenil tablets and are even stamped 'Plaqenil' to make things even more confusing).

    If that is the case then I would indeed be out of luck with regards to switching to a generic since my stomach cannot tolerate the Prasco Labs tablet even tho the package insert lists the same ingredients (sans percentages, of course).

    This is why I posted the question here on HU to see if any other U.S. person has successfully tried the Zentiva version.

    Still holding out hope!

  • Good for you and cheers! MaryF

  • I have and still use Hydrox sulfate. is this one in the same you are or have tried ?

  • Hydroxychloroquine sulfate is the same. That is the chemical name for Plaquenil. I have no issues with the drug, it's the fillers and/or amounts of fillers that are used in the generics.

  • The manufacturer of mine is Mylan --200ml's

  • Yes that is one manufacturer of a generic. I have not tried that one.

    The issue with a generic is that the pharmacy can fill the script with whatever generic they have on hand so there is no guarantee you will consistently get the same one. After trying two generic brands with the same stomach/GI issues I really don't want to cycle through all of them. Especially when there would never be a guarantee I would always get that one.

    The Zentiva brand appears to be different since a doc could call that one out specifically. AND it is rumored that it is indeed the same formulation as the name brand Plaquenil. Whether or not that is actually true remains to be seen.

  • I had an issue with just that -- the pharmacy would use what ever they wanted and i found an article on the problems that can cause with the INR . and i am and have always had this Bad Bad bounce .

    so i had my Dc's send them an E saying that they can use a generic BUT it must be one they stock and available ALL the time and that is what i must have .

    So i know all to well what you are talking about because I Have lived it myself .

    Best of luck to you and let me know how you make out ..

    C & J

  • Will do! Thanks so much for your input! 😊

  • :-)

  • I have an update since I have spoken to my pharmacist.

    The Zentiva brand is NOT available in the U.S. (That actually makes sense to me since the sister company (Sanofi) stopped making it for the U.S. in 2013 (that is when Covis took it over). Concordia is the new manufacturer of Plaquenil for U.S. (since Apr 2015)).

    The pharmacist could not tell me which U.S. generic is the equivalent (and to be quite frank, I doubt ANY generic is an EXACT equivalent to the name brand since the manufacturers do not disclose the percentages of inactive ingredients in their formulations. All they are required to do is disclose a list of inactive ingredients, which you can find on sites like Drugs.com or via the actual drug inserts).

    So I did some "comparison shopping". Those of you in the UK are actually quite lucky since it "appears" (based solely upon ingredients list), that the Zentiva brand of hydroxychloroquine sulfate is indeed identical to the Sanofi name brand. I do hope that is true!!

    Just so you all have the information I found, here is the inactive ingredients list for Sanofi Plaquenil (white round film-coated tablet imprinted with HCQ 200):

    Lactose monohydrate

    Maize starch

    Magnesium stearate

    Polypovidone

    Hypromellose

    Macrogol

    Titanium dioxide (E171)

    And here is the inactive ingredients list for the Zentiva Hydroxychloroquine (white round film-coated table imprinted with HCQ 200):

    Lactose monohydrate

    Maize starch

    Magnesium stearate

    Polyvidone

    Opadry OY-L-28900 (containing hypromellose, macrogol 4000, titanium dioxide (E171), lactose)

    Now, for those of us in the U.S., well we don't appear to be quite as lucky. For my own peace of mind, I created a table of all the generic brands I could locate and compared their list of inactive ingredients to what is in the namebrand Plaquenil manufactured by Covis. Most have all sorts of additional fillers. The only one that is the closest is by Prasco Labs, which I recently tried and already know causes me issues (it's better than the Ranbaxy generic - that one was just awful).

    So, I can either play the "let's try all the generic brands" game or I can simply stay with the namebrand and perhaps, switch in the Prasco generic every other day or so, or even, take 200mg of the generic in the am and take 100mg of the namebrand in the afternoon (my dose per day is 300 mg, split, and yes, I have to cut pills in half for the afternoon dose).

    At least now I have answers and hopefully, this information will help anyone in the same boat.

    Tracy

  • I have an update since I have spoken to my pharmacist.

    The Zentiva brand is NOT available in the U.S. (That actually makes sense to me since the sister company (Sanofi) stopped making it for the U.S. in 2013 (that is when Covis took it over). Concordia is the new manufacturer of Plaquenil for U.S. (since Apr 2015)).

    The pharmacist could not tell me which U.S. generic is the equivalent (and to be quite frank, I doubt ANY generic is an EXACT equivalent to the name brand since the manufacturers do not disclose the percentages of inactive ingredients in their formulations. All they are required to do is disclose a list of inactive ingredients, which you can find on sites like Drugs.com or via the actual drug inserts).

    So I did some "comparison shopping". Those of you in the UK are actually quite lucky since it "appears" (based solely upon ingredients list), that the Zentiva brand of hydroxychloroquine sulfate is indeed identical to the Sanofi name brand. I do hope that is true!!

    Just so you all have the information I found, here is the inactive ingredients list for Sanofi Plaquenil (white round film-coated tablet imprinted with HCQ 200):

    Lactose monohydrate

    Maize starch

    Magnesium stearate

    Polypovidone

    Hypromellose

    Macrogol

    Titanium dioxide (E171)

    And here is the inactive ingredients list for the Zentiva Hydroxychloroquine (white round film-coated table imprinted with HCQ 200):

    Lactose monohydrate

    Maize starch

    Magnesium stearate

    Polyvidone

    Opadry OY-L-28900 (containing hypromellose, macrogol 4000, titanium dioxide (E171), lactose)

    Now, for those of us in the U.S., well we don't appear to be quite as lucky. For my own peace of mind, I created a table of all the generic brands I could locate and compared their list of inactive ingredients to what is in the namebrand Plaquenil manufactured by Covis. Most have all sorts of additional fillers. The only one that is the closest is by Prasco Labs, which I recently tried and already know causes me issues (it's better than the Ranbaxy generic - that one was just awful).

    So, I can either play the "let's try all the generic brands" game or I can simply stay with the namebrand and perhaps, switch in the Prasco generic every other day or so, or even, take 200mg of the generic in the am and take 100mg of the namebrand in the afternoon (my dose per day is 300 mg, split, and yes, I have to cut pills in half for the afternoon dose).

    At least now I have answers and hopefully, this information will help anyone in the same boat.

    Tracy

You may also like...