Kremers Urban Pharmaceuticals Inc. Lock Members Only close arrow-right cart search google-plus facebook twitter youtube flickr linkedin calendar user menu menu-close print share circle-down help briefcase latest recon star word-bubble news. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Patients should not make changes to their treatment except in consultation with their health care professional.
If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing health care provider to discuss whether or not a different drug product would be more appropriate. An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.
FDA included the authorized generic in its analysis and found it to be bioequivalent to, and substitutable for, Concerta. Apart from the Mallinckrodt, Kudco, and Actavis products, there are no other generics for Concerta. Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours.
This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride. In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to hour range.
Would you like to support my work —at no cost to you? Simply begin your Amazon shopping expeditions in the box to right. Thank you! Also free free to make a Paypal donation to me of any amount. Several years ago, many Concerta users became accustomed to receiving the authorized generic the brand marketed at a generic, at generic pricing through a company called Actavis.
That is no more. That marketing agreement expired. Then, Actavis was purchased by Teva. And, the company released its own Concerta generic. Shortly after, Concerta manufacturer Janssen made the authorized generic available through a subsidiary, Patriot Pharmaceuticals.
A few drugstores reliably honored the request. Now, fewer do, as the clown car of cheap Concerta generics keeps flooding the market. For the most part, these generics resemble generics of Ritalin or Ritalin LA —and perhaps cost pennies to make, in China or India. The medication methylphenidate is released at a steadily ascending rate. With the generics, it tends to be uneven, in jumps, starts, and stalls—with a fast drop-off.
Try to get the authorized generic from Patriot Pharmaceuticals from your local or mail-order pharmacy. This involves your prescribers cooperation in specifying using specific information, detailed below How to Specify. Please know that this process worked for about a year. It is getting harder and harder to find success that way. Check the terms at the link. It works with your insurance.
Does not apply in MA or CA. How long will this remain useful? Subscribe to stay tuned — and check back often. I accessed this information from the U. You cannot rely just on the name.
All the Concerta generics including the authorized generic are named this! Note: If your pharmacy says that number is not coming up in their database, they might instead find the digit billing code. For example, the 36 mg replaces one hyphen with a zero. No ironclad answers here. Your prescriber might have a preference. The pharmacy might, too. Try to get a straight answer from the pharmacy before speaking with your physician. In the best of all possible worlds, the script need only contain the name of the drug!
That makes it critical to establish which one. To be crystal clear, the prescription should read something like this for example, for the 36 mg dose :. Note: Some readers report that their pill bottles exclude the HCl which stands for hydrochloride. Tricky Bit! Generic substitution laws vary by state.
But what happens when the prescriber checks that box AND specifies a generic but uses the name of the brand Concerta instead of Methylphenidate HCI, etc.
Anything can happen! But again, ask your pharmacist first! If you use a home-delivery pharmacy, consider attaching a note detailing clearly your request. Maybe print and include this blog post. Some of the true generics utilize osmotic technology. Many pharmacists do not know this! You might need to tell them! NOTE : Look before you pay! The pills should look exactly the same as the brand—because they are the brand. Look for the word a lza on the pill.
Not there? It depends on your state laws. Again, check this article in U. Pharmacist : Generic-Substitution Laws. Before you leave the pharmacy or open a home-delivery bottle, look for the label. It should say Patriot Pharmaceuticals. Do not pay for the prescription until you check the label and the pills themselves. Or check out savings from GoodRx. Yes, this is legal! If you remain confused about generic vs. Many readers seem to remain confused. I understand the confusion. They are not. Consumer beware.
In fact, the authorized generic is the bran d. This typically happens when a brand drug patent nears expiration. The manufacturer, Jannsen, agreed to let a company named Watson sell its brand Concerta as an authorized generic. As time went on, Watson became Actavis and Teva purchased Actavis.
The osmotic -controlled release oral delivery system , OROS, takes the form of a rigid tablet with a semi-permeable outer membrane and one or more small laser-drilled holes in it. This is what most of us regard as a generic medication. Unfortunately, pharmacy insurance benefits increasingly force consumers to accept these generics or pay a very high cost for the brand. Over the last two years, the situation has grown even more confusing. Patriot Pharmaceuticals, as shown on the label above.
Patriot is a subsidiary of Concerta manufacturer Janssen. The corporate office tells me there is no planned termination date for this arrangement. Patriot Pharmaceutical Generics are authorized for sale to trade customers by the NDA holder of the innovator product.
It the vehicle through which a company proposes that the FDA approve a new pharmaceutical for sale and marketing in the U. Not a new generic of an existing brand, a new pharmaceutical altogether. The entire Patriot family of products is made by the same manufacturers that are approved in the NDAs of the innovator products. I know this is a lot to take in! It was a lot to research and attempt to write—and constantly re-write—about clearly, too—not to mention field reader questions.
I hope these quick points clarify things for you. If not, leave a question in the comments section. Readers who have followed my suggestions precisely seem to have a higher success rate. Many argue that without that delivery system, it cannot be a reasonable substitute for brand Concerta. My blog readers played a critical role in asking the FDA to reassess the first two Concerta generics the FDA ended up downgrading them as not being close enough to Concerta.
To be frank, I see no hope of reversing this horrible decision by FDA Chief Gottlieb he left after about 17 months, back to the rightwing think tank, the American Enterprise Institute.
We are stuck. As I mentioned, the FDA was incredibly responsive to our complaints about the first two Concerta generics, but that was a different White House administration. You can download a PDF or file directly online.
I answer all questions as quickly as possible. Would you like to support my work —in a cost-free way? Simply begin your Amazon shopping expeditions in the box to the right.
Gina Pera. Called two Costco pharmacy today.
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