FDA Orange Book · active-ingredient family
Mesalamine
Mesalamine is approved as 9 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DELZICOL · NDA 204412
9
Brand (NDA)
35
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release, capsule, extended release, enema, suppository, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DELZICOLRLD | ABBVIE | NDA 204412 | — | Feb 01, 2013 | |
| APRISORLD | SALIX | NDA 022301 | AB | Oct 31, 2008 | |
| ASACOL HDRLD | ABBVIE | NDA 021830 | — | May 29, 2008 | |
| LIALDARLD | TAKEDA PHARMS USA | NDA 022000 | AB | Jan 16, 2007 | |
| CANASARLD×2 | ABBVIE | NDA 021252 | AB | Nov 05, 2004 | |
| PENTASARLD×2 | TAKEDA PHARMS USA | NDA 020049 | AB | May 10, 1993 | |
| ROWASARLD | MEDA PHARMS | NDA 019919 | — | Dec 18, 1990 | |
| ROWASARLD×2 | MYLAN SPECIALITY LP | NDA 019618 | AB | Dec 24, 1987 | |
| ASACOL | APIL | NDA 019651 | — | Jan 31, 1992 |
Generic (ANDA) products (35)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MESALAMINE | KLM LABS PVT | ANDA 220016 | AB | Mar 31, 2026 | |
| MESALAMINE×2 | DIFGEN PHARMS | ANDA 219997 | AB | Mar 10, 2026 | |
| MESALAMINE | ANNORA PHARMA | ANDA 219864 | AB | Aug 13, 2025 | |
| MESALAMINE | NOVITIUM PHARMA | ANDA 215269 | AB | Apr 16, 2025 | |
| MESALAMINE | RISING | ANDA 219028 | AB | Apr 14, 2025 | |
| MESALAMINE | AMNEAL | ANDA 215067 | AB | Feb 18, 2025 | |
| MESALAMINE | NOVAST LABS | ANDA 218410 | AB | Aug 22, 2024 | |
| MESALAMINE | TEVA PHARMS INC | ANDA 213191 | AB | Aug 22, 2024 | |
| MESALAMINE | ANNORA PHARMA | ANDA 216334 | AB | Feb 05, 2024 | |
| MESALAMINE | AMTA | ANDA 217533 | AB | Jun 06, 2023 | |
| MESALAMINE | ENCUBE | ANDA 216941 | AB | May 30, 2023 | |
| MESALAMINE | SINOTHERAPEUTICS INC | ANDA 217337 | AB | May 12, 2023 | |
| MESALAMINE | AUROBINDO PHARMA LTD | ANDA 214477 | AB | Mar 31, 2023 | |
| MESALAMINE | ALEMBIC | ANDA 216967 | AB | Oct 28, 2022 | |
| MESALAMINE | SUN PHARM | ANDA 214585 | AB | May 11, 2022 | |
| MESALAMINE | TEVA PHARMS USA | ANDA 209970 | — | May 06, 2022 | |
| MESALAMINE | ZYDUS PHARMS | ANDA 208954 | AB | Aug 12, 2021 | |
| MESALAMINE | ALKEM LABS LTD | ANDA 214242 | AB | Jul 15, 2021 | |
| MESALAMINE | ACTAVIS MID ATLANTIC | ANDA 205654 | AB | Aug 14, 2020 | |
| MESALAMINE | ANNORA PHARMA | ANDA 213377 | AB | Mar 19, 2020 | |
| MESALAMINE | ZYDUS PHARMS | ANDA 208953 | AB | Feb 12, 2020 | |
| MESALAMINE | AMNEAL | ANDA 210509 | — | Jan 02, 2020 | |
| MESALAMINE | MYLAN | ANDA 207271 | AB | Nov 20, 2019 | |
| MESALAMINE | AMRING PHARMS | ANDA 208362 | AB | Jun 21, 2019 | |
| MESALAMINE | SANDOZ | ANDA 202065 | AB | Jun 12, 2019 | |
| MESALAMINE | TEVA PHARMS USA | ANDA 207873 | — | May 09, 2019 | |
| MESALAMINE | RISING | ANDA 207448 | AB | Apr 19, 2019 | |
| MESALAMINE | SUN PHARM | ANDA 211858 | AB | Jan 25, 2019 | |
| MESALAMINE | MYLAN | ANDA 203574 | — | Nov 20, 2018 | |
| MESALAMINE | ACTAVIS LABS FL | ANDA 203817 | AB | Mar 23, 2018 | |
| MESALAMINE | ZYDUS PHARMS | ANDA 203286 | AB | Jul 21, 2017 | |
| MESALAMINE | ZYDUS PHARMS | ANDA 091640 | AB | Jun 05, 2017 | |
| MESALAMINE | QUAGEN | ANDA 204354 | AB | Nov 24, 2015 | |
| MESALAMINE | G AND W LABS INC | ANDA 076841 | — | Sep 30, 2004 | |
| MESALAMINE | PADAGIS ISRAEL | ANDA 076751 | AB | Sep 17, 2004 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7645801 | Jul 24, 2027 | in 1 yr 1 mo | SubstanceProduct |
| 8217083 | Jun 06, 2028 | in 2 yr | Product |
| 8436051 | Jun 06, 2028 | in 2 yr | Product |
| 8865688 | May 01, 2030 | in 3 yr 11 mo | U-1310 |
Mesalamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
