DrugPatentWatch Database Preview
VYVANSE Drug Profile
When do Vyvanse patents expire, 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. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
US ANDA Litigation and 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 2017 were $2.3bn, 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: | 147 |
| US Patents: | 18 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 22 |
| Clinical Trials: | 57 |
| Patent Applications: | 574 |
| 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 |
| DailyMed Link: | VYVANSE at DailyMed |
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 |
|---|---|
| Purdue Pharma, Canada | Phase 4 |
| Matthew O'Brien | Phase 4 |
| Aaron Keshen | Phase 2 |
Recent Litigation for VYVANSE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| IMPAX LABORATORIES, INC. v. ACTAVIS LABORATORIES FL, INC. | 2015-09-17 |
| SHIRE LLC v. MYLAN PHARMACEUTICALS, INC. | 2012-02-02 |
| Shire LLC v. Watson Laboratories Inc | 2012-01-05 |
Pharmacology for VYVANSE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Synonyms for VYVANSE
| (2S)-2,6-Diamino-N-((1S)-1-methyl-2-phenylethyl)hexanamide |
| (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 |
| (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide |
| (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanimidic acid |
| 137L333 |
| 608137-32-2 |
| 608137-33-3 |
| AKOS030254940 |
| AN-27750 |
| BCP24044 |
| CETWSOHVEGTIBR-FORAGAHYSA-N |
| CHEBI:135925 |
| CHEMBL1201178 |
| CHEMBL1201222 |
| CTK5B2291 |
| D04747 |
| D08130 |
| DB01255 |
| DTXSID00209652 |
| DTXSID60209653 |
| Elvanse (TN) |
| GTPL7213 |
| H645GUL8KJ |
| HSDB 8277 |
| L-lysine-d-amphetamine |
| L-Lysine-d-amphetamine dimesylate |
| LDX |
| Ldx;Lisdexamfetamine mesilate;Lisdexamfetamine mesylate;Nrp 104;Nrp-104;Spd 489 |
| lis-dexamfetamine dimesylate |
| Lisdexamfetamine |
| Lisdexamfetamine (INN) |
| Lisdexamfetamine [INN] |
| 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 |
| LS-187377 |
| Lys-Amp |
| Lys-d-Amp |
| NRP 104 |
| NRP-104 |
| NRP104 |
| SB17446 |
| SCHEMBL158949 |
| SCHEMBL678421 |
| SJT761GEGS |
| SPD 489 |
| SPD-489 |
| SPD489 |
| UNII-H645GUL8KJ |
| UNII-SJT761GEGS |
| Venvanse |
| Vyvanse (TN) |
| ZINC11680943 |
Paragraph IV (Patent) Challenges for VYVANSE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-005 | Dec 10, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Dev Llc | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-006 | Jan 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-006 | Dec 10, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-001 | Feb 23, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Dev Llc | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-002 | Jan 28, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1088254 | Start Trial |
| Japan | 2005524648 | Start Trial |
| Norway | 20056211 | Start Trial |
| European Patent Office | 1257592 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0052078 | Start Trial |
| Austria | 545427 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYVANSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1644019 | 37/2016 | Austria | Start 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 | 122013000079 | Germany | Start 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 | C01644019/01 | Switzerland | Start Trial | PRODUCT NAME: LISDEXAMPHETAMIN; REGISTRATION NO/DATE: SWISSMEDIC 63023 27.03.2014 |
| 1644019 | 1390058-4 | Sweden | Start 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 | SPC/GB13/052 | United Kingdom | Start Trial | PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201 |
| 1644019 | 549 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
