FDA Orange Book · active-ingredient family
Ephedrine sulfate
Ephedrine sulfate: 5 brands, 18 generics; first approved Apr 29, 2016; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
5
Generics (ANDA)
18
Listed patents
7
Next patent expiry
Jan 22, 2040
in 13 yr 8 mo
Brand (NDA) products
Originator applications
- NEXUSNDA 21340720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP1 25MG/5ML (5MG/ML) SOLUTION INTRAVENOUS Rx — - EPHEDRINE SULFATERLDRSPH HEALTHNDA 21399420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP2 25MG/5ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP2 - EXELA PHARMANDA 20828920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP 25MG/5ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP3 - EPHEDRINE SULFATERENEW PHARMSNDA 2086092017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Discontinued — - PH HEALTHNDA 2089432017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (18)
Abbreviated applications
- EPHEDRINE SULFATEBAXTER HLTHCARE CORPANDA 2167402026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEFRESENIUS KABI USAANDA 2199912026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP2 - EPHEDRINE SULFATECIVICAANDA 2155932025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Discontinued — - EPHEDRINE SULFATEFRESENIUS KABI USAANDA 21827120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP2 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP2 - EPHEDRINE SULFATEGLANDANDA 2182112025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP1 - EPHEDRINE SULFATEHIKMAANDA 2177212024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP3 - EPHEDRINE SULFATECAPLINANDA 2190502024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEZYDUS PHARMSANDA 2172762023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Discontinued — - EPHEDRINE SULFATESAGENT PHARMS INCANDA 2145282023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEXIROMEDANDA 2158252022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEMANKIND PHARMAANDA 2161292022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEGLANDANDA 2161462022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEEUGIA PHARMAANDA 2145792021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEHIKMAANDA 2143342020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEDR REDDYSANDA 2126492020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEFRESENIUS KABI USAANDA 2096462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATEAMNEALANDA 2129322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP - EPHEDRINE SULFATESANDOZANDA 2097842017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML (50MG/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- PCPatent-challenge (180-day generic) exclusivity
5 mo ago
- PCPatent-challenge (180-day generic) exclusivity
5 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12029710 | in 13 yr 8 mo | U-3963 | |
| 10869845 | in 13 yr 8 mo | Product | |
| 11571398 | in 14 yr | U-3183 | |
| 11464752 | in 14 yr | Product | |
| 11478436 | in 14 yr | U-3183 | |
| 11090278 | in 14 yr | U-3183 | |
| 11241400 | in 14 yr | U-3183 |
Approval history
FDA approval span
First approval
10 yr 5 mo ago
Most recent approval
27 d ago
Approvals span 2016–2026 across 23 FDA applications.
Brand (NDA) 522%
Generic (ANDA) 1878%
Ephedrine 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.
