FDA Orange Book · active-ingredient family
Telmisartan
Telmisartan is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MICARDIS · NDA 020850
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MICARDISRLD×3 | BOEHRINGER INGELHEIM | NDA 020850 | — | Apr 04, 2000 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TELMISARTAN×3 | MACLEODS PHARMS LTD | ANDA 203986 | AB | Jan 15, 2025 | |
| TELMISARTAN×3 | MANKIND PHARMA | ANDA 218157 | AB | Oct 15, 2024 | |
| TELMISARTAN×3 | HISUN PHARM HANGZHOU | ANDA 207843 | — | Feb 19, 2019 | |
| TELMISARTAN×3 | MICRO LABS | ANDA 207016 | AB | Oct 03, 2017 | |
| TELMISARTAN×3 | CADILA PHARMS LTD | ANDA 208605 | AB | Jul 25, 2017 | |
| TELMISARTAN×3 | PRINSTON INC | ANDA 207882 | AB | May 03, 2017 | |
| TELMISARTAN×3 | JUBILANT GENERICS | ANDA 204164 | AB | Aug 22, 2016 | |
| TELMISARTAN×3 | HETERO LABS LTD V | ANDA 205901 | — | Apr 22, 2016 | |
| TELMISARTAN×3 | INVENTIA | ANDA 205150 | AB | Oct 30, 2015 | |
| TELMISARTAN×3 | AMNEAL PHARMS | ANDA 204415 | AB | Sep 08, 2015 | |
| TELMISARTAN×3 | AUROBINDO PHARMA | ANDA 206511 | AB | Sep 03, 2015 | |
| TELMISARTAN×3 | SANDOZ | ANDA 203867 | AB | Nov 03, 2014 | |
| TELMISARTAN×3 | ZYDUS PHARMS | ANDA 203325 | AB | Aug 26, 2014 | |
| TELMISARTAN×3 | ALEMBIC | ANDA 202130 | AB | Jul 07, 2014 | |
| TELMISARTAN×3 | GLENMARK PHARMS LTD | ANDA 090032 | AB | Jul 07, 2014 | |
| TELMISARTAN×3 | MYLAN | ANDA 202397 | AB | Jul 07, 2014 | |
| TELMISARTAN×3 | TORRENT | ANDA 203171 | AB | Jul 07, 2014 | |
| TELMISARTAN×3 | CHARTWELL RX | ANDA 078710 | AB | Jan 08, 2014 |
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.
Telmisartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
