VYVANSE Drug Patent Profile
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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: | 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-003 | Feb 23, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-005 | Dec 10, 2007 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-005 | Jan 28, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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) | 0234237 | ⤷ Try a Trial | |
China | 100413533 | ⤷ Try a Trial | |
European Patent Office | 2319540 | Composés pharmaceutiques à libération prolongée pour prévenir l'abus de substances réglementées (Sustained release pharmaceutical compounds to prevent abuse of controlled substances) | ⤷ Try a Trial |
Austria | 519502 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1644019 | 122013000079 | Germany | ⤷ Try a Trial | 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 | 2013/038 | Ireland | ⤷ Try a Trial | 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 | 37/2016 | Austria | ⤷ Try a Trial | 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 | CA 2013 00043 | Denmark | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |