does vyvanse have an expiration date

Does Vyvanse have an expiration date?

Hello friends. Welcome to solsarin. Here today’s discussion is about “does Vyvanse have an expiration date?”. Please stay with us until the end of the discussion and then share your idea.

What is Vyvanse?

Vyvanse is a brand-name prescription medication. It’s FDA-approved to treat the following conditions:*

attention deficit hyperactivity disorder (ADHD) in adults and in children ages 6 years and older
moderate to severe binge eating disorder in adults

Is Vyvanse a stimulant?

Yes, Vyvanse is a stimulant medication. It contains the active drug lisdexamfetamine dimesylate, which is a type of drug calling an amphetamine.

Vyvanse is a controlled substance. It’s classified by the FDA as a Schedule II controlled drug.

This means it has a high potential for misuse. It also has a high risk of causing dependence (meaning your body needs the drug to function normally).

There are special rules around how Vyvanse is prescribed and dispensed. It’s important to keep it in a safe place to prevent misuse. And it’s illegal to give or sell Vyvanse to someone for whom it’s not prescribed.

Drug details

Vyvanse comes in the following forms that are taken by mouth:

chewable tablet, which is available in strengths of 10 milligrams (mg), 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
capsule, which is available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg

Vyvanse is taken once per day.

Does Vyvanse Expire?

Yes, like most other available medications, Vyvanse expires, and it does have an expiration date.

The FDA requires drug manufacturers to publish expiration dates or “best before” dates. The expiry date usually means that the medication has been testing for potency up to that date. This also means that the drug manufacturer can’t assure the effectiveness or potency of the medications beyond this expiration date.

Of course, there are high probabilities of Vyvanse or pretty much any medication not actually being “expired” after the expiry date, unlike food.

In most cases, the pharmacists place a “beyond use” or “use by” date on the medication packaging. This date is usually one year after the prescription has been filled. For example, if you fill your Vyvanse prescription on June 1, 2020, then the pharmacy will place a “use by” date on the packaging that is June 1, 2021.

If one takes off the label placed on the package by the pharmacist, you may see the original expiration date published by the manufacturer. The manufacturer’s expiration date may be much later than the date suggested by the pharmacist.

Vyvanse and other medications may not work as effectively beyond their expiration dates. So, it’s always recommending that you dispose of Vyvanse after the expiration date either set by the pharmacists or the manufacturer, whichever seems to be right with a doctor’s advice.

Since Vyvanse is a controlling substance and it’s inactive in its original form and works when activated within the body, it’s always best to dispose of the medication after the expiration. It’s possible to return expired Vyvanse to the pharmacy and have it replaced or refilled.

Can Vyvanse Expire Before Its Expiry Date?

It may be a common occurrence to see medications including Vyvanse looking pale, disoriented, or discolored even before its expiration.

Here it’s important to mention that it may not be a problem of expiration but a problem of storage. Like any other medication, even Vyvanse will have to be storing in a place that meets the right storage conditions. If this is not meeting, then Vyvanse may start to lose its proper form and properties, which can be dangerous when consuming, even if it’s before the expiration.

Factors such as heat and moisture can particularly affect Vyvanse and make them unusable before the expiry date.

It might also be good to mention here that although many are easy-going in taking expired Vyvanse and says it should work at least 8 months after the expiry, it’s not the same with Vyvanse that has interacted with heat and moisture.

In some respects, taking expired Vyvanse could be way better than taking Vyvanse that has changed its appearance and physical outlook because of interactions. So, that tells us that Vyvanse can be unusable even before its expiration and might be potentially more harmful when consumed compared to expired Vyvanse.

However, many users of Vyvanse do ask the question of whether or not Vyvanse works the same beyond its expiration date, especially considering Vyvanse is a controlled and expensive drug. Doing so would save a lot of cost and inconvenience if it works the same beyond the expiration. So, let’s take a look at that next.

Side Effects Of Vyvanse

While Vyvanse is safe as long as it is taking as prescribed, there are some side effects.

Some of these side effects might include anxiety, dry mouth, decreased appetite, nausea, weight loss, and even vomiting.

Remember that consuming the medication after expiration will substantially increase your chance of experiencing these negative side effects!

Court Upholds Shire Vyvanse Patents

Shire plc announced that Judge Stanley R. Chesler of the U.S. District Court for the District of New Jersey granted Shire’s summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse (lisdexamfetamine dimesylate) were both infringed and valid.

The ruling prevents the five pharmaceutical manufacturers (the ANDA-Defendants) who have filed Abbreviated New Drug Applications (ANDAs) from launching generic versions of Vyvanse until the earlier of either a successful appeal to the U.S. Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA-Defendants must overturn the Court’s rulings for each of the 18 patent claims.

The Court’s summary judgment ruling concerning Shire’s motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

“We are extremely pleasing with the Court’s ruling, which affirms Shire’s belief that it has strong patents protecting Vyvanse,” said Flemming Ornskov, chief executive officer for Shire.

Shire’s Vyvanse patents expire in 2023 but Shire recently announced that it has agreed to a Written Request by the U.S. Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse for the treatment of ADHD in preschool-age children, ages four to five. Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, Shire will be entitling to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire’s patents for Vyvanse.

Shire’s lawsuit is against the five ANDA-Defendants that filed ANDAs with the U.S. Food and Drug Administration (FDA) seeking to market generic versions of Vyvanse, and their Active Pharmaceutical Ingredient (API) manufacturer of lisdexamfetamine dimesylate API. The ANDA-Defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The API manufacturer and supplier to each of the ANDA-Defendants is Johnson Matthey Inc./Johnson Matthey Pharmaceutical Materials. This lawsuit includes all of the known ANDAs that are currently pending for Vyvanse.

The Court found that “[t]here is no real dispute about the ANDA Defendants’ direct infringement of the compound claims,” Johnson Matthey “is liable for inducing the ANDA Defendants’ direct infringement of the compound claims,” and “the ANDA Defendants have induced infringement” of a claimed method of treating ADHD.

As to validity, the Court found that “defendants have not shown that lisdexamfetamine was disclosed in the prior art” and “defendants have failed to point to evidence sufficient to persuade a reasonable jury that [prior art reference] AU ’168 anticipates by disclosing lisdexamfetamine dimesylate;” and “have failed to defeat the motion for summary judgment regarding invalidity due to obviousness of the compound patents.”

Additionally, the Court found that “defendants have not offered evidence sufficient to prove [method of treating ADHD] claim 4 of the ’486 patent is invalid due to obviousness or anticipation.”

Shire’s summary judgment motion did not include every patent claim in the litigation and, accordingly, the Court’s decision did not dispose of the litigation in its entirety. In addition to Shire’s motion, the Court also ruled on five summary judgment motions filed by the defendants. The Court’s rulings denied API-supplier Johnson Matthey’s motion to dismiss certain indirect infringement claims, dismissed Shire’s willful infringement claims, granted defendants’ motion concerning non-infringement of certain method of use claims, and denied defendants’ two invalidity motions.

At this point, the Court must decide whether to conduct a trial on the remaining patent claims, or allow the defendants to immediately appeal this ruling to the Federal Circuit. Shire maintains its belief that it has strong infringement claims against each of the six defendants for the patent claims that were not including in Shire’s motion, and strongly believes that the asserted patent claims are valid.

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