FDA Orange Book · active-ingredient family
Hydrochlorothiazide; telmisartan
Hydrochlorothiazide; telmisartan is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MICARDIS HCT · NDA 021162
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MICARDIS HCTRLD×3 | BOEHRINGER INGELHEIM | NDA 021162 | AB | Nov 17, 2000 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | MANKIND PHARMA | ANDA 218406 | — | Mar 03, 2025 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | GLENMARK PHARMS LTD | ANDA 202544 | AB | Mar 04, 2019 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | PRINSTON INC | ANDA 209028 | AB | Nov 06, 2017 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | ZYDUS PHARMS | ANDA 204221 | AB | Aug 15, 2017 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | AUROBINDO PHARMA | ANDA 208727 | AB | Dec 15, 2016 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | MACLEODS PHARMS LTD | ANDA 204169 | — | Nov 02, 2015 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | LUPIN | ANDA 091351 | AB | Aug 07, 2014 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | ALEMBIC | ANDA 203010 | AB | Feb 25, 2014 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | NATCO | ANDA 091648 | — | Feb 25, 2014 | |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE×3 | TORRENT | ANDA 201192 | — | Feb 25, 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.
Hydrochlorothiazide; telmisartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
