VYVANSE Drug Patent Profile
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When do Vyvanse patents expire, 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: | 154 |
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 |
Recent Clinical Trials for VYVANSE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Early Phase 1 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2/Phase 3 |
Yale University | 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 | |||
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 03034980 | ⤷ Sign Up | |
South Korea | 20110061654 | ABUSE RESISTANT AMPHETAMINE COMPOUNDS | ⤷ Sign Up |
Israel | 154583 | ⤷ Sign Up | |
Australia | 2008201969 | A novel pharmaceutical compound and methods of making and using same | ⤷ Sign Up |
China | 1720059 | Sustained release pharmaceutical compounds to prevent abuse of controlled substances | ⤷ Sign Up |
Poland | 1644019 | ⤷ 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 | 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 | 122013000079 | Germany | ⤷ Sign Up | 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 | 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 | 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 | C01644019/01 | Switzerland | ⤷ Sign Up | VERTRETERLOESCHUNG |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |