By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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VYVANSE Drug 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. There are eighteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and forty-eight patent family members in twenty-seven countries.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
DrugPatentWatch® Generic Entry Outlook for Vyvanse
Vyvanse was eligible for patent challenges on February 23, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 24, 2023. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $3.3bn, indicating a strong incentive for generic entry.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are five tentative approvals for the generic drug (lisdexamfetamine dimesylate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for VYVANSE
| International Patents: | 148 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Clinical Trials: | 58 |
| Patent Applications: | 1,487 |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VYVANSE
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, CHEWABLE;ORAL |
*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.
Recent Clinical Trials for VYVANSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yale University | Phase 2/Phase 3 |
| Purdue Pharma, Canada | Phase 4 |
| Matthew O'Brien | Phase 4 |
Pharmacology for VYVANSE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
ATC Classes for VYVANSE
Paragraph IV (Patent) Challenges for VYVANSE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VYVANSE | CAPSULE;ORAL | lisdexamfetamine dimesylate | 021977 | 2020-04-09 |
| VYVANSE | CAPSULE;ORAL | lisdexamfetamine dimesylate | 021977 | 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 | 021977-002 | Feb 23, 2007 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-006 | Dec 10, 2007 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-001 | Feb 23, 2007 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-003 | Jan 28, 2017 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Takeda Pharms Usa | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-002 | Jan 28, 2017 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1644019 | Try Before You Buy |
| New Zealand | 546226 | Try Before You Buy |
| Poland | 1644019 | Try Before You Buy |
| Canada | 2367042 | Try Before You Buy |
| China | 1925865 | Try Before You Buy |
| European Patent Office | 2316469 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1644019 | CR 2013 00043 | Denmark | Try Before You Buy | 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 | Try Before You Buy | 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 | Try Before You Buy | 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 | C01644019/01 | Switzerland | Try Before You Buy | PRODUCT NAME: LISDEXAMPHETAMIN; REGISTRATION NO/DATE: SWISSMEDIC 63023 27.03.2014 |
| 1644019 | 37/2016 | Austria | Try Before You Buy | 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 | LUC00189 | Luxembourg | Try Before You Buy | PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 202009252 A 202009257 20200901 (LU); PL08081/0050-52 20130201 (GB) |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
