VYVANSE Drug Patent Profile
✉ Email this page to a colleague
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.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Fifteen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vyvanse
A generic version of VYVANSE was approved as lisdexamfetamine dimesylate by ALKEM LABS LTD on August 25th, 2023.
Summary for VYVANSE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 23 |
Clinical Trials: | 65 |
Patent Applications: | 150 |
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 |
![VYVANSE drug patent expirations Drug patent expirations by year for VYVANSE](/p/graph/s/t/VYVANSE-patent-expirations.png)
![Drug Prices for VYVANSE](/p/graph/drug-price/VYVANSE.png)
![Drug Sales Revenue Trends for VYVANSE](/p/graph/drug-sales-revenues/VYVANSE.png)
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
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 | 021977-007 | Oct 30, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-003 | Feb 23, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-005 | Dec 10, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-005 | Jan 28, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-001 | Jan 28, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-001 | Feb 23, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|
Japan | 4625637 | ⤷ Sign Up | |
European Patent Office | 1257592 | UTILISATION DE LA CONFORMATION D'UNE PROTEINE POUR LA PROTECTION ET LA LIBERATION DE COMPOSES CHIMIQUES (USE OF PROTEIN CONFORMATION FOR THE PROTECTION AND RELEASE OF CHEMICAL COMPOUNDS) | ⤷ Sign Up |
South Africa | 200510383 | Abuse resistant amphetamine compounds | ⤷ Sign Up |
European Patent Office | 1311242 | SYSTEMES DE LIBERATIONS D'AGENTS ACTIFS ET PROCEDES DE PROTECTION ET D'ADMINISTRATION D'AGENTS ACTIFS (ACTIVE AGENT DELIVERY SYSTEMS AND METHODS FOR PROTECTING AND ADMINISTERING ACTIVE AGENTS) | ⤷ Sign Up |
Israel | 174683 | ⤷ Sign Up | |
Eurasian Patent Organization | 010295 | СОЕДИНЕНИЯ АМФЕТАМИНА С ПОНИЖЕННОЙ СПОСОБНОСТЬЮ ВЫЗЫВАТЬ ЗЛОУПОТРЕБЛЕНИЕ ИМИ (ABUSE RESISTANT AMPHETAMINE COMPOUNDS) | ⤷ Sign Up |
South Korea | 20060102556 | PHARMACEUTICAL COMPOSITIONS FOR PREVENTION OF OVERDOSE OR ABUSE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1644019 | 2013/038 | Ireland | ⤷ Sign Up | PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002 |
1644019 | 301019 | Netherlands | ⤷ Sign Up | 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 | 2020C/543 | Belgium | ⤷ Sign Up | PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520 |
1644019 | CR 2013 00043 | Denmark | ⤷ Sign Up | 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 | CA 2013 00043 | Denmark | ⤷ Sign Up | PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER ET MESYLAT SALT; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201 |
1644019 | C01644019/01 | Switzerland | ⤷ Sign Up | VERTRETERLOESCHUNG |
1644019 | LUC00189 | Luxembourg | ⤷ Sign Up | 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 |