FDA Orange Book · active-ingredient family
Tranexamic acid
Tranexamic acid is approved as 4 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRANEXAMIC ACID · NDA 212020
4
Brand (NDA)
31
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANEXAMIC ACIDRLD | EXELA PHARMA | NDA 212020 | AP | Apr 15, 2019 | |
| LYSTEDARLD | AMRING PHARMS | NDA 022430 | AB | Nov 13, 2009 | |
| CYKLOKAPRONRLD | PFIZER | NDA 019281 | AP | Dec 30, 1986 | |
| CYKLOKAPRON | PHARMACIA AND UPJOHN | NDA 019280 | — | Dec 30, 1986 |
Generic (ANDA) products (31)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANEXAMIC ACID | I 3 PHARMS | ANDA 219702 | AB | Jan 26, 2026 | |
| TRANEXAMIC ACID | BIONPHARMA | ANDA 219123 | — | Aug 19, 2025 | |
| TRANEXAMIC ACID | APPCO | ANDA 218729 | AB | Jun 11, 2025 | |
| TRANEXAMIC ACID | HERITAGE | ANDA 218896 | AP | Jun 02, 2025 | |
| TRANEXAMIC ACID | FRESENIUS KABI USA | ANDA 218242 | AP | Aug 15, 2024 | |
| TRANEXAMIC ACID | RUBICON RESEARCH | ANDA 218320 | AB | Jun 11, 2024 | |
| TRANEXAMIC ACID | GLAND | ANDA 218599 | AP | Apr 16, 2024 | |
| TRANEXAMIC ACID | NEXUS | ANDA 216877 | AP | Apr 16, 2024 | |
| TRANEXAMIC ACID | AMNEAL | ANDA 217155 | AP | Oct 16, 2023 | |
| TRANEXAMIC ACID | APOTEX | ANDA 209860 | AP | Jan 14, 2020 | |
| TRANEXAMIC ACID | CAPLIN | ANDA 212360 | AP | Jul 17, 2019 | |
| TRANEXAMIC ACID | MILLA PHARMS | ANDA 212676 | AP | Jul 17, 2019 | |
| TRANEXAMIC ACID | EPIC PHARMA LLC | ANDA 206594 | — | Sep 28, 2017 | |
| TRANEXAMIC ACID | ZYDUS PHARMS | ANDA 205228 | — | Jul 17, 2017 | |
| TRANEXAMIC ACID | MICRO LABS | ANDA 206713 | AP | Jun 27, 2017 | |
| TRANEXAMIC ACID | AMNEAL PHARMS CO | ANDA 208840 | AP | Feb 28, 2017 | |
| TRANEXAMIC ACID | GLAND | ANDA 207239 | AP | Feb 13, 2017 | |
| TRANEXAMIC ACID | ANI PHARMS | ANDA 203256 | AB | Jul 25, 2016 | |
| TRANEXAMIC ACID | RISING | ANDA 206634 | — | Jun 09, 2016 | |
| TRANEXAMIC ACID | CHARTWELL RX | ANDA 202755 | — | Feb 25, 2016 | |
| TRANEXAMIC ACID | EUGIA PHARMA | ANDA 205035 | AP | Jan 14, 2016 | |
| TRANEXAMIC ACID | AUROBINDO PHARMA USA | ANDA 205133 | AB | Sep 21, 2015 | |
| TRANEXAMIC ACID | AVET LIFESCIENCES | ANDA 203521 | AP | Aug 12, 2014 | |
| TRANEXAMIC ACID | HERITAGE | ANDA 202436 | AP | Feb 11, 2014 | |
| TRANEXAMIC ACID | APOTEX | ANDA 202286 | — | Jan 27, 2014 | |
| TRANEXAMIC ACID | XGEN PHARMS | ANDA 201580 | AP | Jun 14, 2013 | |
| TRANEXAMIC ACID | ACTAVIS LABS FL INC | ANDA 202093 | AB | Dec 27, 2012 | |
| TRANEXAMIC ACID | FRESENIUS KABI USA | ANDA 091596 | — | Mar 02, 2012 | |
| TRANEXAMIC ACID | EPIC PHARMA LLC | ANDA 202373 | AP | Nov 17, 2011 | |
| TRANEXAMIC ACID | MYLAN INSTITUTIONAL | ANDA 091657 | AP | Nov 03, 2011 | |
| TRANEXAMIC ACID | AM REGENT | ANDA 201885 | AP | Aug 10, 2011 |
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.
Tranexamic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
