FDA Approves Mesalamine Delayed–Release Tablets, Generic of Lialda, for UC

FDA Approves Mesalamine Delayed–Release Tablets, Generic of Lialda, for UC

The U.S. Food and Drug Administration (FDA) has given final approval for Zydus Cadila to market Mesalamine Delayed–Release Tablets USP, a generic version of Lialda, in the U.S. to treat ulcerative colitis (UC).

The announcement follows news in May that Zydus had won a court battle over Shire’s patent for Lialda. The U.S. Court of Appeals for the Federal Circuit ruled that Zydus’ proposed generic version of Lialda does not infringe upon Shire’s patent covering the drug.

Zydus, owned by India’s Cadila Healthcare, was the first company that questioned Shire’s rights to Lialda by filing an abbreviated new drug application with the FDA for a generic version of Lialda in 2010, according to reporting by Law360.

Mesalamine is a compound that has been around for years and is not patent protected. Shire’s patent covers the release mechanism, allowing the drug to travel through the intestines untouched until it reaches the colon. U.S. Patent No. 6,773,720 protects this delayed-release mechanism.

Lialda, developed and commercialized by Shire, is currently approved for the induction of remission in patients with active mild-to-moderate ulcerative colitis. It can also be used for the maintenance of remission. The recommended dosage for the induction of remission in adult patients with active mild to moderate UC is two to four 1.2–gram tablets taken once daily with a meal for a total daily dose of 2.4 grams or 4.8 grams.

The recommended dosage for the maintenance of remission is two 1.2–gram tablets taken once daily with a meal for a total daily dose of 2.4 grams.

According to Zydus estimates, brand sales for Mesalamine Delayed-Release Tablets USP, 1.2 grams, could be as high as $1.1 billion. The generic version of Lialda will be produced at the Moraiya plant in Ahmedabad, India.

UC is an inflammatory bowel disease (IBD) that causes long–lasting inflammation and ulcers in the digestive tract. The disease affects the innermost lining of the large intestine and rectum. Symptoms usually develop over time rather than suddenly. UC can be debilitating and lead to life–threatening complications. While currently there is no cure, treatment can reduce signs and symptoms of the disease.

33 comments

    • Not a happy camper says:

      Lialda also offered discounts each year… $500 off each month for the first 3 months and $120 off each month after that for the remainder of the year. I only take 2 tablets a day so my cost was $10 a month but now my insurance company won’t cover name brand as long as a generic is available. So lucky me I get to pay $455.02 a month for Zydus.

      • Pam S. says:

        My insurance company said have doctor write a prescription for “Lialda brand only”. Also they said after 6 months generic may get cheaper, keep checking prices.

    • AL Franks says:

      It would be wonderful news if Zydus offered manufacture discount cards like Lialda does. I will be pauing full price now for Zydus until I meet my insurance deductible of $2800, because insurance company won’t cover name brand as long as there is a generic. The price is $561.02 for Lialda and $445.25 for Zydus for one month 60 tables. Lialda discounts are $500 a month for the first 3 months and $120 a month for the rest of the year. So this is not good news for many people.

      • JM says:

        Also Shire now makes a generic mesalamine too (strange times we live in). If you don’t have good discounts through your insurance, try going to the goodrx website for discounts or see if AAA or others offer Rx discount cards. Via goodrx, Walmart shows 120 tablets for $311 as of today. For some reason 120 tablets gives a better price per tablet than 60.

  1. Bob says:

    What a BAG O Bull $hiT. Finally a Generic for Lialda and it’s just VERY moderately less expensive. Went through this same CRAP with Asacol. Time for the patent to run out and they change the pill cover and low and behold, patent renewed. Change to Lialda then the same ole same ole. Congratulations to those who once again screw the sick. Time to put some kind of price control on these money hungry/grubbing bastards. Profit, sure. Billions in sales off of the sick and tens of millions for the CEO’s whose only wise way of running these companies is, “Raise the prices”. WOW.

  2. Pam S. says:

    I was just notified Lialda Savings cards are discontinued as of October 15. I doubt they will offer them again in 2018 but I will check in January.

  3. Angie says:

    I just got the letter telling me the discount card will no longer be available. Of course I need a refill in a few days. Not sure I can afford it. 😔

  4. Kelly says:

    Just got my letter from Shire today, 10/12, telling me the discount card is no longer effective as of 10/15. I sure hope my insurance pays a lot more towards the generic then they did towards Lialda or my UC is going to flare up from the financial stress!

  5. Shame, I do not like the fact that I’m taking a generic I’m paying for Lialda and somehow I’ve been switched system generic crap I don’t like it and I intend to let everybody know it it cost me $216 and some odd sense and my Lialda was $200 when I’m in the donut hole. I don’t know why I was switched to a generic but I will find out I’m not happy about it and I hope everybody else is not happy about it. I want the drug and the brand I have been taking not a generic I didn’t pay for a generic and that’s not what I want I’ve been getting it filled at Kmart for several years and now they’ve switched on me and I don’t like it. I will call my colon specialist and find out about what I’m taking that might be hurting me when I should be taken what he ordered

  6. Chris Drew says:

    Where can this new Zydus be purchased or can it be? I was also just notified Lialda Savings cards are discontinued as of October 15 (today). I doubt they will offer them again in 2018 but I will check in January. They are now after the money till Allergan new generic is also available. This should go to a higher court, another drug company screwing the consumer.

  7. Concerned Patient says:

    The generic Mesalamine is being made by Cadila Healthcare in Ahmedabad, India, a company sited by the FDA in December 2015 for poor practices and contaminated medicines. Has anyone had problems, or gotten sick from taking the generic Lialda?
    I’m concerned, and don’t want to take the generic brand being forced on me.

  8. Lynn Hooker says:

    It is so unfair how much we have to pay for a drug to keep our Crohns under control. I received the discontinued letter from Shire two days prior to them dropping the program. I does look like they would have given you a fair notice so you could start looking around for an alternative drug. No one cares. Now it’s either quit taking 2 pills a day for Crohns or take one pill a day so it will last longer when you get a three month supply.

  9. Roberta Webb says:

    Unbeknownst to me Walgreens filled my prescription of lialda with the generic and I suffered the worst abdominal pains and uncontrolled BM’s for weeks. When I took the generic I knew immediately there was a problem since it started to dissolve in my mouth and not in my colon like a UC/colitis drug is manufactured to to. As all of those who suffer and take a drug to control UC or colitis, the drug is not supposed to dissolve until it is in the colon and not on the tongue. Who knows what stomach acids do to compromise the integrity of the generic drug. One of the worst generic drug products approved by the FDA. Again, the consumer suffers all in the name of monetary savings!!! I hope those who approved the generic, never ever have to suffer bowel habits on a daily basis like we do; it will change your life forever!!

  10. H Marx says:

    Zydus is a lousy generic house. I reported them to the FDA once — I suspected them of underdosing the capsules of one of their meds consistently. While I’m glad there finally is a generic Mesalamine, go for the Shire-made one.

    And I never got a letter saying they were discontinuing the discount card, so this is news to me.

  11. Tom says:

    Pharmacy switched my refill to the generic. within three days of taking it I noticed I was cramping more. Talked to gastro doc who told me that while the main ingredient is Mesalsmine, the fillers are diferent in the generic and I must be reacting to them. He wrote me a “brand name only” prescription and handed me a new Lialda saving card. Took to pharmacy and was told the savings card is no longer any good since the generic came on the market!

  12. Myra Gomez says:

    I also received the letter that the lialda card would no longer be available. Although my co-payment for the generic will be $10 a month. Hopefully I will habe good results with the generic.

  13. Bruce Gorenflo says:

    I am also having to use the generic now, and after about a month of taking it, my UC symptoms have returned (after nearly four years of no symptoms on Lialda). I am going to call my gastroenterologist and see if he can prescribe the real Lialda only, and will find out how my prescription insurance handles it.

  14. Ann says:

    I have been on the generic for about a month and went from stable, to loose stools, to constipated of all things for the last 3 days. Wth!?! NOT happy to take a drug made in cesspool India. My old company wouldn’t even make greeting cards there. Now I’m supposed to put a drug in my body made with water, liquids in it and used to rinse their equipment by water with cow crap and human remains in it? Our friends were there last year and showed us pictures of starving cows laying in the street and eating garbage. Also of bodies floating down the river that get dumped into it after being burned at a crematorium for two hours. Why does the FDA allow ANYTHING for consumption in from this country? And it’s not partisan…evil big Pharma!!!

  15. Jo says:

    My pharmacy also switched me from Lialda to generic. I had horrible reaction to generic after just two days – severe cramping, acid reflux, loose and bloody BM. I was doing great with Lialda and felt like I was in remission, but the generic version has made me go downhill quickly that I refuse to take it. I’m looking to get samples at doctors office until I can refill with brand name only. Hope the generic gets recalled or pulled from shelf because it is NOT the sand as Lialda.

Leave a Comment

Your email address will not be published. Required fields are marked *