FDA Orange Book · active-ingredient family
Amphetamine
Amphetamine: 2 brands, 1 generic; first approved Jan 27, 2016; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
5
Next patent expiry
Apr 09, 2026
4 mo ago
Brand (NDA) products
Originator applications
- ADZENYS ERRLDNEOS THERAPS INCNDA 2043252017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.25MG BASE/ML SUSPENSION, EXTENDED RELEASE ORAL Discontinued — - NEOS THERAPSNDA 20432620166 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- AMPHETAMINEACTAVIS LABS FL INCANDA 20925320236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8840924 | 4 mo ago | Product | |
| 8709491 | in 6 yr | Product | |
| 9017731 | in 6 yr | Product | |
| 9265737 | in 6 yr | Product | |
| 9839619 | in 6 yr | Product |
Approval history
FDA approval span
First approval
10 yr 8 mo ago
Most recent approval
3 yr 2 mo ago
Approvals span 2016–2023 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Amphetamine: 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.
