FDA Orange Book · active-ingredient family
Aminocaproic acid
Aminocaproic acid is approved as 4 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AMICAR · NDA 015197
4
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMICARRLD×2 | HIKMA | NDA 015197 | AB | Jun 24, 2004 | |
| AMICARRLD | EPIC PHARMA LLC | NDA 015229 | — | Approved Prior to Jan 1, 1982 | |
| AMICARRLD | HIKMA | NDA 015230 | AA | Approved Prior to Jan 1, 1982 | |
| AMINOCAPROIC ACID | BAXTER HLTHCARE | NDA 018590 | — | Oct 29, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMINOCAPROIC ACID | ZENARA | ANDA 215374 | AP | Aug 28, 2025 | |
| AMINOCAPROIC ACID | SCIEGEN PHARMS | ANDA 213216 | AA | May 19, 2025 | |
| AMINOCAPROIC ACID | MSN | ANDA 215100 | AA | Sep 26, 2024 | |
| AMINOCAPROIC ACID | SUNNY | ANDA 213213 | AA | Dec 27, 2023 | |
| AMINOCAPROIC ACID×2 | MSN | ANDA 212938 | AB | Sep 13, 2023 | |
| AMINOCAPROIC ACID | TARO | ANDA 214458 | — | Mar 24, 2023 | |
| AMINOCAPROIC ACID | ANNORA PHARMA | ANDA 216464 | AA | Nov 04, 2022 | |
| AMINOCAPROIC ACID | AUROBINDO PHARMA | ANDA 216804 | AA | Sep 26, 2022 | |
| AMINOCAPROIC ACID×2 | RISING | ANDA 213944 | AB | Sep 14, 2022 | |
| AMINOCAPROIC ACID | REGCON HOLDINGS | ANDA 215510 | AA | Mar 23, 2022 | |
| AMINOCAPROIC ACID | ADAPTIS | ANDA 212110 | — | Jun 14, 2021 | |
| AMINOCAPROIC ACID | AJENAT PHARMS | ANDA 213825 | AA | Apr 08, 2021 | |
| AMINOCAPROIC ACID×2 | CARNEGIE | ANDA 213928 | AB | Feb 12, 2021 | |
| AMINOCAPROIC ACID | CARNEGIE | ANDA 214140 | AA | Jan 26, 2021 | |
| AMINOCAPROIC ACID | ANI PHARMS | ANDA 211629 | — | Dec 14, 2020 | |
| AMINOCAPROIC ACID | TP ANDA HOLDINGS | ANDA 212494 | AA | Aug 11, 2020 | |
| AMINOCAPROIC ACID | VISTAPHARM LLC | ANDA 212814 | — | Feb 26, 2020 | |
| AMINOCAPROIC ACID | AMNEAL | ANDA 212492 | AB | Nov 26, 2019 | |
| AMINOCAPROIC ACID | AMNEAL | ANDA 212780 | AA | Aug 23, 2019 | |
| AMINOCAPROIC ACID×2 | SUNNY | ANDA 209060 | AB | Nov 27, 2018 | |
| AMINOCAPROIC | HIKMA | ANDA 075602 | — | May 24, 2001 | |
| AMINOCAPROIC ACID | EPIC PHARMA LLC | ANDA 074759 | — | Sep 02, 1998 | |
| AMINOCAPROIC ACID | HOSPIRA | ANDA 070888 | — | Jun 16, 1988 | |
| AMINOCAPROIC ACID | LUITPOLD | ANDA 071192 | AP | Dec 01, 1987 | |
| AMINOCAPROIC ACID IN PLASTIC CONTAINER | HOSPIRA | ANDA 070010 | AP | Mar 09, 1987 | |
| AMINOCAPROIC ACID | ABRAXIS PHARM | ANDA 070522 | — | Jun 17, 1986 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Aminocaproic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
