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, 10 months ago) |
Expired
|
| US7659253 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7662787 | Abuse resistant lysine amphetamine compounds |
Feb, 2023
(1 year, 10 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, 4 months ago) |
Expired
|
|
US7662788 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7700561 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7723305 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7671030 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7718619 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7662787 (Pediatric) | Abuse resistant lysine amphetamine compounds |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7671031 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7674774 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7713936 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7105486 (Pediatric) | Abuse-resistant amphetamine compounds |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7223735 (Pediatric) | Abuse resistant lysine amphetamine compounds |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7655630 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7659253 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7659254 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7678770 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7687466 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
|
US7687467 (Pediatric) | Abuse-resistant amphetamine prodrugs |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
| US7700561 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7105486 | Abuse-resistant amphetamine compounds |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7223735 | Abuse resistant lysine amphetamine compounds |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7687467 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7678771 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7678770 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7674774 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7671031 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7662788 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7659253 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7671030 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7718619 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7713936 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7723305 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7659254 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7655630 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7687466 | Abuse-resistant amphetamine prodrugs |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US7662787 | Abuse resistant lysine amphetamine compounds |
Feb, 2023
(1 year, 10 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.
Latest 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 |
|---|---|---|
 | ||
| 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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. 17 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.
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 - capsule form for oral use, tablet, chewable 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 |