VYVANSE Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
Which patents cover Vyvanse, and when can generic versions of Vyvanse launch?
Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and forty-eight patent family members in twenty-seven countries.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
DrugPatentWatch® Generic Entry Outlook for Vyvanse
Vyvanse was eligible for patent challenges on February 23, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 24, 2023. This may change due to patent challenges or generic licensing.
Annual sales in 2019 were $3.4bn, indicating a strong incentive for generic entry.
There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are six tentative approvals for the generic drug (lisdexamfetamine dimesylate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for VYVANSE
International Patents: | 148 |
US Patents: | 19 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 65 |
Patent Applications: | 822 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VYVANSE |
Drug Sales Revenues: | Drug sales revenues for VYVANSE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYVANSE |
What excipients (inactive ingredients) are in VYVANSE? | VYVANSE excipients list |
DailyMed Link: | VYVANSE at DailyMed |



DrugPatentWatch® Estimated Generic Entry Opportunity Date for VYVANSE
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, CHEWABLE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VYVANSE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Early Phase 1 |
Yale University | Phase 2/Phase 3 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2/Phase 3 |
Pharmacology for VYVANSE
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes for VYVANSE
Paragraph IV (Patent) Challenges for VYVANSE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VYVANSE | Capsules | lisdexamfetamine dimesylate | 10 mg | 021977 | 1 | 2020-04-09 |
VYVANSE | Capsules | lisdexamfetamine dimesylate | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | 021977 | 6 | 2011-02-23 |
US Patents and Regulatory Information for VYVANSE
VYVANSE is protected by nineteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYVANSE is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VYVANSE
Abuse-resistant amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse resistant lysine amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse resistant lysine amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-002 | Feb 23, 2007 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-006 | Dec 10, 2007 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-001 | Feb 23, 2007 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-003 | Jan 28, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-002 | Jan 28, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VYVANSE
See the table below for patents covering VYVANSE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 545427 | See Plans and Pricing | |
China | 1720059 | Sustained release pharmaceutical compounds to prevent abuse of controlled substances | See Plans and Pricing |
Israel | 174683 | See Plans and Pricing | |
Mexico | PA05012850 | COMPUESTOS DE ANFETAMINA RESISTENTES AL ABUSO. (ABUSE RESISTANT AMPHETAMINE COMPOUNDS.) | See Plans and Pricing |
European Patent Office | 1644019 | COMPOSES D'AMPHETAMINE RESISTANT AUX ABUS (ABUSE RESISTANT AMPHETAMINE COMPOUNDS) | See Plans and Pricing |
Canada | 2420590 | SYSTEMES DE LIBERATIONS D'AGENTS ACTIFS ET PROCEDES DE PROTECTION ET D'ADMINISTRATION D'AGENTS ACTIFS (ACTIVE AGENT DELIVERY SYSTEMS AND METHODS FOR PROTECTING ANDADMINISTERING ACTIVE AGENTS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1644019 | 37/2016 | Austria | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMIN, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, INSBESONDERE EINES MESILAT-SALZES; NAT. REGISTRATION NO/DATE: 136851-136853 20160412; FIRST REGISTRATION: PL08081/0050-PL08081/0052 20130201 |
1644019 | CR 2013 00043 | Denmark | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET MESYLAT ELLER HYDROCHLORID SALT DERAF; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201 |
1644019 | 301019 | Netherlands | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMINE, DESGEWENST IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDEZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 124498 20190528; FIRST REGISTRATION: GB PL 08081/0050-52 20130201 |
1644019 | 1390058-4 | Sweden | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMIN VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT, SAERSKILT ETT MESYLATSALT; NAT. REG. NO/DATE: 47382 20130722; FIRST REG.: GB PL 08081/0050-52 20130201 |
1644019 | 122013000079 | Germany | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201 |
1644019 | LUC00189 | Luxembourg | See Plans and Pricing | PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |