FDA Orange Book · active-ingredient family
Epinephrine
Epinephrine: 17 brands, 11 generics; first approved May 23, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
17
Generics (ANDA)
11
Listed patents
28
Next patent expiry
Jan 26, 2026
7 mo ago
Brand (NDA) products
Originator applications
- EPINEPHRINERLDRSBAXTER HLTHCARE CORPNDA 22062620262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx — 30MG/30ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx — - EPINEPHRINERLDRSFRESENIUS KABI USANDA 2154252025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/30ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx — - ARS PHARMS OPERATIONNDA 21469720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/SPRAY SPRAY NASAL Rx — 1MG/SPRAY SPRAY NASAL Rx — - EPINEPHRINERLDRSBPI LABSNDA 20502920245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS Rx AP 10MG/10ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — 30MG/30ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP 1MG/ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - PH HEALTHNDA 21587520235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/250ML (8MCG/ML) SOLUTION INTRAVENOUS Rx — 4MG/250ML (16MCG/ML) SOLUTION INTRAVENOUS Rx — 5MG/250ML (20MCG/ML) SOLUTION INTRAVENOUS Rx — 8MG/250ML (32MCG/ML) SOLUTION INTRAVENOUS Rx — 10MG/250ML (40MCG/ML) SOLUTION INTRAVENOUS Rx — - EPINEPHRINERLDRSINTL MEDICATION SYSNDA 2113632022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Rx — - EPINEPHRINERLDHOSPIRANDA 2093592019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) SOLUTION INTRAVENOUS Discontinued — - ARMSTRONG PHARMSNDA 2059202018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG/INH AEROSOL, METERED INHALATION OTC — - SYMJEPIRLDADAMIS PHARMS CORPNDA 20753420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.3MG/0.3ML (0.3MG/0.3ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Rx — 0.15MG/0.3ML (0.15MG/0.3ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Discontinued — - AUVI-QRLDKALEO INCNDA 20173920173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG/DELIVERY SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Rx BX EQ 0.15MG/DELIVERY SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Rx BX EQ 0.1MG/DELIVERY SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Rx — - PH HEALTHNDA 2046402013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - PH HEALTHNDA 2042002012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - IMPAXNDA 02080020094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Discontinued — EQ 0.15MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Discontinued — EQ 0.15MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx BX EQ 0.3MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx BX - VIATRISNDA 01943019874 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.3MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx AB 0.15MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx AB 0.3MG/DELIVERY INJECTABLE INTRAMUSCULAR Discontinued — 0.15MG/DELIVERY INJECTABLE INTRAMUSCULAR Discontinued — - FOREST LABSNDA 00794219992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — 1.5MG/AMP INJECTABLE INJECTION Discontinued — - STERLINGNDA 016803—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/INH AEROSOL, METERED INHALATION Discontinued — - WYETH CONSNDA 016126—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/INH AEROSOL, METERED INHALATION Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- EPINEPHRINEHIKMAANDA 2205622026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - EPINEPHRINEAMNEALANDA 2182082025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - EPINEPHRINEAMNEALANDA 2174852025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - EPINEPHRINEGLANDANDA 2181442025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS Rx AP - EPINEPHRINEGLANDANDA 21923920252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/10ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP 30MG/30ML (1MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - EPINEPHRINEFRESENIUS KABI USAANDA 2137082024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML (1MG/ML) SOLUTION INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS Rx AP - EPINEPHRINEAM REGENTANDA 2171922024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - EPINEPHRINEINTL MEDICATION SYSANDA 2118802020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Rx AP - TEVA PHARMS USAANDA 09058920182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.3MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx AB 0.15MG/DELIVERY INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS Rx AB - EPINEPHRINEAM REGENTANDA 2075682018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued — - EPINEPHRINEARMSTRONG PHARMSANDA 0879071984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/INH AEROSOL, METERED INHALATION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8367734 | 7 mo ago | Product | |
| 11590286 | in 4 mo | Product | |
| 8206360 | in 6 mo | Product | |
| 7947017 | in 1 yr 7 mo | Product | |
| 8231573 | in 2 yr 4 mo | Product | |
| 8226610 | in 2 yr 8 mo | Product | |
| 8021344 | in 3 yr 3 mo | Product | |
| 9295657 | in 8 yr 8 mo | U-1829 | |
| 9119876 | in 8 yr 8 mo | Product | |
| 12280024 | in 8 yr 8 mo | Product | |
| 10130592 | in 8 yr 8 mo | Product | |
| 11141540 | in 10 yr 4 mo | ProductU-3379 | |
| 10688244 | in 11 yr 6 mo | ProductU-2980 | |
| 10842938 | in 11 yr 6 mo | ProductU-2980 | |
| 11771830 | in 11 yr 6 mo | ProductU-2980 | |
| 11173209 | in 11 yr 8 mo | U-3979 | |
| 10576156 | in 11 yr 8 mo | Product | |
| 11918655 | in 12 yr 8 mo | U-3979 | |
| 11744895 | in 12 yr 8 mo | U-3979 | |
| 11717571 | in 12 yr 8 mo | U-3979 | |
| 11191838 | in 12 yr 8 mo | ProductU-3979 | |
| 10682414 | in 12 yr 8 mo | U-3979 | |
| 12324838 | in 12 yr 8 mo | Product | |
| 11083698 | in 12 yr 9 mo | U-3567 | |
| 10653646 | in 12 yr 9 mo | Product | |
| 11207280 | in 12 yr 9 mo | Product | |
| 12133837 | in 12 yr 9 mo | Product | |
| 12539283 | in 18 yr 8 mo | Product |
Approval history
FDA approval span
First approval
42 yr 10 mo ago
Most recent approval
3 mo ago
Approvals span 1984–2026 across 28 FDA applications.
Brand (NDA) 1761%
Generic (ANDA) 1139%
Epinephrine: 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.
