Vyvanse Patent Expiration

Vyvanse is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 36 US drug patents filed from 2013 to 2021 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2023. Details of Vyvanse's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7655630 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7659253 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7662787 Abuse resistant lysine amphetamine compounds
Feb, 2023

(1 year, 9 months ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7678771

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7662788

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7700561

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7723305

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7671030

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7718619

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7662787

(Pediatric)

Abuse resistant lysine amphetamine compounds
Aug, 2023

(1 year, 3 months ago)

Expired
US7671031

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7674774

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7713936

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7105486

(Pediatric)

Abuse-resistant amphetamine compounds
Aug, 2023

(1 year, 3 months ago)

Expired
US7223735

(Pediatric)

Abuse resistant lysine amphetamine compounds
Aug, 2023

(1 year, 3 months ago)

Expired
US7655630

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7659253

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7659254

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7678770

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7687466

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7687467

(Pediatric)

Abuse-resistant amphetamine prodrugs
Aug, 2023

(1 year, 3 months ago)

Expired
US7700561 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7105486 Abuse-resistant amphetamine compounds
Feb, 2023

(1 year, 9 months ago)

Expired
US7223735 Abuse resistant lysine amphetamine compounds
Feb, 2023

(1 year, 9 months ago)

Expired
US7687467 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7678771 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7678770 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7674774 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7671031 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7662788 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7659253 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7671030 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7718619 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7713936 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7723305 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7659254 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7655630 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7687466 Abuse-resistant amphetamine prodrugs
Feb, 2023

(1 year, 9 months ago)

Expired
US7662787 Abuse resistant lysine amphetamine compounds
Feb, 2023

(1 year, 9 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Vyvanse's patents.

Given below is the list of recent legal activities going on the following patents of Vyvanse.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 21 Oct, 2021 US7718619 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 21 Oct, 2021 US7713936
Payment of Maintenance Fee, 12th Year, Large Entity 21 Oct, 2021 US7723305 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 24 Sep, 2021 US7700561 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7674774 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7687466 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7678770 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7671031 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7671030 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 18 Aug, 2021 US7678771 (Litigated)


FDA has granted several exclusivities to Vyvanse. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyvanse, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vyvanse.

Exclusivity Information

Vyvanse holds 6 exclusivities. All of its exclusivities have expired in 2019. Details of Vyvanse's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Feb 23, 2012
M(M-82) Apr 05, 2013
New Patient Population(NPP) Nov 10, 2013
New Indication(I-645) Jan 31, 2015
New Indication(I-703) Jan 30, 2018
M(M-188) Oct 14, 2019

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Several oppositions have been filed on Vyvanse's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vyvanse's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vyvanse patents.

Vyvanse's Oppositions Filed in EPO

Vyvanse has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 15, 2012, by Hexal Ag. This opposition was filed on patent number EP04753925A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP04753925A Nov, 2012 JOHNSON MATTHEY PUBLIC LIMITED COMPANY Patent maintained as amended
EP04753925A Nov, 2012 Generics [UK] Limited Patent maintained as amended
EP04753925A Nov, 2012 Hexal AG Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Vyvanse is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vyvanse's family patents as well as insights into ongoing legal events on those patents.

Vyvanse's Family Patents

Vyvanse has patent protection in a total of 27 countries. It has a significant patent presence in the US with 85.9% of its patents being US patents. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vyvanse.

Family Patents

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Generic Launch

Generic Release Date:

Vyvanse's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Vyvanse Generic API suppliers:

Lisdexamfetamine Dimesylate is the generic name for the brand Vyvanse. 16 different companies have already filed for the generic of Vyvanse, with Sun Pharm Inds Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vyvanse's generic

How can I launch a generic of Vyvanse before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Vyvanse's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vyvanse's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Vyvanse -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg 09 Apr, 2020 1 24 Feb, 2023 Extinguished
20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg 23 Feb, 2011 6 24 Feb, 2023 Extinguished

Alternative Brands for Vyvanse

Vyvanse which is used for managing symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in both adults and children., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Noven Pharms Inc
Daytrana used for managing symptoms of attention deficit hyperactivity disorder (ADHD)
Supernus Pharms
Qelbree Used for managing symptoms of ADHD.





About Vyvanse

Vyvanse is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in both adults and children. Vyvanse uses Lisdexamfetamine Dimesylate as an active ingredient. Vyvanse was launched by Takeda Pharms Usa in 2017.

Approval Date:

Vyvanse was approved by FDA for market use on 28 January, 2017.

Active Ingredient:

Vyvanse uses Lisdexamfetamine Dimesylate as the active ingredient. Check out other Drugs and Companies using Lisdexamfetamine Dimesylate ingredient

Treatment:

Vyvanse is used for managing symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in both adults and children.

Dosage:

Vyvanse is available in the following dosage forms - tablet, chewable form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
60MG TABLET, CHEWABLE Prescription ORAL
70MG CAPSULE Prescription ORAL
50MG TABLET, CHEWABLE Prescription ORAL
20MG TABLET, CHEWABLE Prescription ORAL
10MG TABLET, CHEWABLE Prescription ORAL
30MG TABLET, CHEWABLE Prescription ORAL
40MG TABLET, CHEWABLE Prescription ORAL


Vyvanse News

Takeda Pharmaceutical Faces a Decline in Third-Quarter Net Profit due to Reduced Margins | Morningstar

01 Feb, 2024

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