FDA Orange Book · active-ingredient family
Lisdexamfetamine dimesylate
Lisdexamfetamine dimesylate: 3 brands, 22 generics; first approved Feb 23, 2007; generic available.
Generic available
Generic status & protection
Generic available: 22 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
22
Listed patents
3
Next patent expiry
Apr 16, 2040
in 13 yr 9 mo
Brand (NDA) products
Originator applications
- AZURITYNDA 2198472025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx — - VYVANSERLDTAKEDA PHARMS USANDA 20851020176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - VYVANSERLDTAKEDA PHARMS USANDA 02197720147 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB
Generic (ANDA) products (22)
Abbreviated applications
- LISDEXAMFETAMINE DIMESYLATEGRANULESANDA 21898720257 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATESANDOZANDA 20283620247 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATESPECGX LLCANDA 21885020246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEGRANULESANDA 21925820246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEELITE LABS INCANDA 21860420247 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEMSNANDA 21830620246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEHIKMAANDA 20282720247 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEACTAVIS ELIZABETHANDA 20280220237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEALKEM LABS LTDANDA 21719420237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEAMNEALANDA 20283020236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEAPOTEXANDA 21694420237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEASCENT PHARMS INCANDA 21744220237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATELANNETT CO INCANDA 21580220237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEMYLANANDA 20283520237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATENORWICHANDA 21454720237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEPRINSTON INCANDA 21626620237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATERHODES PHARMSANDA 21533020237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATESPECGX LLCANDA 21184020237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATESUN PHARM INDS INCANDA 21448420237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 60MG CAPSULE ORAL Rx AB 70MG CAPSULE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATEASCENT PHARMS INCANDA 21706820236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATESUN PHARM INDS INCANDA 21413420236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB - LISDEXAMFETAMINE DIMESYLATETEVA PHARMSANDA 21541520236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Rx AB 20MG TABLET, CHEWABLE ORAL Rx AB 30MG TABLET, CHEWABLE ORAL Rx AB 40MG TABLET, CHEWABLE ORAL Rx AB 50MG TABLET, CHEWABLE ORAL Rx AB 60MG TABLET, CHEWABLE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12433859 | in 13 yr 9 mo | ProductU-842 | |
| 12582620 | in 13 yr 9 mo | Product | |
| 11576878 | in 14 yr 1 mo | Product |
Approval history
FDA approval span
First approval
19 yr 11 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 2007–2025 across 25 FDA applications.
Brand (NDA) 312%
Generic (ANDA) 2288%
Lisdexamfetamine dimesylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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