DrugPatentWatch Database Preview
VYVANSE Drug Profile
Which patents cover Vyvanse, and when can generic versions of Vyvanse launch?
Vyvanse is a drug marketed by Shire Development and Shire Dev Llc and is included in two NDAs. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-seven patent family members in twenty-six countries.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for VYVANSE
| International Patents: | 147 |
| US Patents: | 18 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Clinical Trials: | 56 |
| Patent Applications: | 444 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VYVANSE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYVANSE |
| DailyMed Link: | VYVANSE at DailyMed |
Generic Entry Opportunity Date for VYVANSE
*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.
Pharmacology for VYVANSE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for VYVANSE
Synonyms for VYVANSE
| (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenyl-ethyl]hexanamide; methanesulfonic acid |
| (2S)-2,6-DIAMINO-N-[(1S)-1-METHYL-2-PHENYLETHYL]HEXANAMIDE DIMETHANESULFONATE |
| 137L333 |
| 608137-33-3 |
| AKOS030254940 |
| AN-27750 |
| BIS(METHANESULFONIC ACID); VYVANSE |
| CETWSOHVEGTIBR-FORAGAHYSA-N |
| CHEMBL1201178 |
| CTK5B2291 |
| D04747 |
| DTXSID60209653 |
| Elvanse (TN) |
| L-Lysine-d-amphetamine dimesylate |
| lis-dexamfetamine dimesylate |
| Lisdexamfetamine dimesylate |
| Lisdexamfetamine dimesylate (USAN) |
| Lisdexamfetamine dimesylate [USAN] |
| Lisdexamfetamine dimesylate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Lisdexamfetamine mesilate |
| Lisdexamfetamine mesilate (JAN) |
| Lisdexamfetamine mesylate |
| LS-186600 |
| Lys-Amp |
| Lys-d-Amp |
| NRP 104 |
| NRP-104 |
| OR074086 |
| SCHEMBL678421 |
| SJT761GEGS |
| SPD 489 |
| SPD-489 |
| SPD489 |
| UNII-SJT761GEGS |
| Venvanse |
| Vyvanse (TN) |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-005 | Dec 10, 2007 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Dev Llc | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-005 | Jan 28, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-006 | Dec 10, 2007 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Shire Dev Llc | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-006 | Jan 28, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for VYVANSE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for VYVANSE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 03079972 | ➤ Sign Up |
| Japan | 2005524648 | ➤ Sign Up |
| China | 101193650 | ➤ Sign Up |
| Australia | 2004251647 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 13/038 | 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 |
| 2013000079 | 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 |
| /2016 | Austria | ➤ Sign Up | 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 |
| 90058-4 | Sweden | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
