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 | |||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-001 | 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 |
|---|---|---|---|
| Canada | 2603873 | PROMEDICAMENTS A BASE D'AMPHETAMINE RESISTANTS A LA CONSOMMATION ABUSIVE (ABUSE-RESISTANT AMPHETAMINE PRODRUGS) | ⤷ Try a Trial |
| Japan | 2006516948 | ⤷ Try a Trial | |
| European Patent Office | 2316469 | Système de distribution et méthodes de protection et d'administration de dextroamphetamine (Delivery system and methods for protecting and administering dextroamphetamine) | ⤷ Try a Trial |
| South Korea | 20030064388 | ⤷ Try a Trial | |
| Norway | 20056211 | ⤷ 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 | CR 2013 00043 | Denmark | ⤷ Try a Trial | 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 | 1390058-4 | Sweden | ⤷ Try a Trial | 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 | 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 | LUC00189 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901 |
| 1644019 | 2020C/543 | Belgium | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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