DrugPatentWatch Database Preview
VYVANSE Drug Profile
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When do Vyvanse patents expire, and when can generic versions of Vyvanse launch?
This drug has one hundred and forty-seven patent family members in twenty-six countries.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Two suppliers are 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: | 2 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 54 |
| Patent Applications: | 79 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYVANSE |
| DailyMed Link: | VYVANSE at DailyMed |
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 |
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Paragraph IV (Patent) Challenges for VYVANSE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | ➤ Subscribe | 2011-02-23 |
Non-Orange Book US Patents for VYVANSE
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,163,918 | Iodothyronine compositions | ➤ Sign Up |
| 7,338,939 | Abuse-resistant hydrocodone compounds | ➤ Sign Up |
| 7,375,082 | Abuse-resistant hydrocodone compounds | ➤ Sign Up |
| 6,716,452 | Active agent delivery systems and methods for protecting and administering active agents | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for VYVANSE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 100822498 | ➤ Sign Up |
| Japan | 2005524648 | ➤ Sign Up |
| Eurasian Patent Organization | 200600696 | ➤ Sign Up |
| European Patent Office | 1357928 | ➤ 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 |
| 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 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
