FDA Orange Book · active-ingredient family
Amphetamine sulfate
Amphetamine sulfate: 1 brand, 17 generics; first approved Aug 31, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
17
Listed patents
3
Next patent expiry
Mar 10, 2037
in 10 yr 8 mo
Brand (NDA) products
Originator applications
- EVEKEO ODTRLDAZURITYNDA 20990520215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 15MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 20MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 2.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued —
Generic (ANDA) products (17)
Abbreviated applications
- AMPHETAMINE SULFATERHODES PHARMSANDA 21385220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMPHETAMINE SULFATEGLENMARK PHARMS LTDANDA 21218620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMPHETAMINE SULFATESUN PHARM INDS INCANDA 21457420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMPHETAMINE SULFATESPECGX LLCANDA 21358320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEALKEM LABS LTDANDA 21372020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEEPIC PHARMA LLCANDA 21398020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEINGENUS PHARMS LLCANDA 21376320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMPHETAMINE SULFATEDR REDDYS LABS SAANDA 21389820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMPHETAMINE SULFATESENORES PHARMSANDA 21290120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEPRINSTON INCANDA 21186120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATESANALUZANDA 21258220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEBIONPHARMAANDA 21291920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEGRANULESANDA 21261920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEAUROLIFE PHARMA LLCANDA 21163920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATEAMNEAL PHARMSANDA 21113920182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AZURITYANDA 20016620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - AMPHETAMINE SULFATERLDLANNETTANDA 08390119842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10441554 | in 10 yr 8 mo | Product | |
| 11160772 | in 10 yr 8 mo | Product | |
| 11896562 | in 10 yr 8 mo | U-3299 |
Approval history
FDA approval span
First approval
42 yr 7 mo ago
Most recent approval
5 yr ago
Approvals span 1984–2021 across 18 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1794%
Amphetamine sulfate: 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.
