FDA Orange Book · active-ingredient family
Levothyroxine sodium
Levothyroxine sodium is approved as 14 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ERMEZA · NDA 215809
14
Brand (NDA)
19
Generics (ANDA)
15
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, powder, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERMEZARLD | MYLAN | NDA 215809 | — | Apr 29, 2022 | |
| LEVOTHYROXINE SODIUMRLD | HIKMA | NDA 214253 | — | May 17, 2021 | |
| THYQUIDITYRLD | STEVENS J | NDA 214047 | — | Nov 30, 2020 | |
| LEVOTHYROXINE SODIUMRLD×3 | FRESENIUS KABI USA | NDA 210632 | — | Apr 11, 2019 | |
| TIROSINT-SOLRLD×15 | IBSA | NDA 206977 | — | Dec 15, 2016 | |
| LEVOTHYROXINE SODIUMRLD×3 | FRESENIUS KABI USA | NDA 202231 | AP | Jun 24, 2011 | |
| TIROSINTRLD×15 | IBSA | NDA 021924 | — | Aug 01, 2007 | |
| THYRO-TABSRLD×12 | ALVOGEN | NDA 021116 | AB1,AB2,AB3,AB4 | Oct 24, 2002 | |
| SYNTHROIDRLD×12 | ABBVIE | NDA 021402 | AB1,AB2 | Jul 24, 2002 | |
| LEVOXYLRLD×12 | KING PHARMS | NDA 021301 | AB1,AB3 | May 25, 2001 | |
| UNITHROIDRLD×12 | STEVENS J | NDA 021210 | AB1,AB2,AB3 | Aug 21, 2000 | |
| LEVOLET×12 | GENUS LIFESCIENCES | NDA 021137 | AB1,AB2,AB3,AB4 | Jun 06, 2003 | |
| EUTHYROX×12 | EMD SERONO INC | NDA 021292 | — | May 31, 2002 | |
| LEVO-T×12 | CEDIPROF INC | NDA 021342 | AB1,AB2,AB3 | Mar 01, 2002 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM×12 | ALEMBIC | ANDA 216370 | AB2 | May 20, 2026 | |
| LEVOTHYROXINE SODIUM×3 | ONESOURCE SPECIALTY | ANDA 216729 | AP | Mar 05, 2025 | |
| LEVOTHYROXINE SODIUM | XIROMED | ANDA 217495 | AP | Nov 29, 2024 | |
| LEVOTHYROXINE SODIUM×5 | AUROBINDO PHARMA | ANDA 216414 | — | Jul 16, 2024 | |
| LEVOTHYROXINE SODIUM×3 | ZYDUS PHARMS | ANDA 217066 | AP | Mar 24, 2023 | |
| LEVOTHYROXINE SODIUM×12 | ASCENT PHARMS INC | ANDA 215259 | AB4 | Jan 18, 2023 | |
| LEVOTHYROXINE SODIUM×12 | MACLEODS PHARMS LTD | ANDA 211417 | AB1,AB2,AB3,AB4 | Dec 21, 2022 | |
| LEVOTHYROXINE SODIUM×12 | WATSON LABS TEVA | ANDA 207588 | AB1,AB2,AB3,AB4 | May 10, 2022 | |
| LEVOTHYROXINE SODIUM×3 | ANI PHARMS | ANDA 213256 | — | Jan 06, 2021 | |
| LEVOTHYROXINE SODIUM×6 | ANI PHARMS | ANDA 211369 | — | Oct 28, 2020 | |
| LEVOTHYROXINE SODIUM×12 | ACCORD HLTHCARE | ANDA 212399 | AB1,AB2,AB3,AB4 | Oct 19, 2020 | |
| LEVOTHYROXINE SODIUM | DR REDDYS | ANDA 208837 | — | Mar 27, 2020 | |
| LEVOTHYROXINE SODIUM×12 | AMNEAL | ANDA 210831 | — | Feb 19, 2019 | |
| LEVOTHYROXINE SODIUM×12 | LUPIN | ANDA 209713 | AB1,AB2,AB3 | Jan 18, 2019 | |
| LEVOTHYROXINE SODIUM×3 | MAIA PHARMS INC | ANDA 208749 | AP | Dec 21, 2018 | |
| LEVOTHYROXINE SODIUM×2 | PIRAMAL CRITICAL | ANDA 206163 | AP | Jun 29, 2016 | |
| LEVOTHYROXINE SODIUM | PH HEALTH | ANDA 205366 | — | Dec 07, 2015 | |
| LEVOTHYROXINE SODIUM×11 | MERCK KGAA | ANDA 076752 | — | Jun 16, 2005 | |
| LEVOTHYROXINE SODIUM×12 | MYLAN | ANDA 076187 | AB1,AB2,AB3,AB4 | Jun 05, 2002 |
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9050307 | Aug 06, 2031 | in 5 yr 2 mo | Product |
| 9168239 | Aug 29, 2032 | in 6 yr 3 mo | Product |
| 9168238 | Aug 29, 2032 | in 6 yr 3 mo | Product |
| 9006289 | Oct 03, 2032 | in 6 yr 5 mo | Product |
| 9345772 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 11154498 | Jul 20, 2036 | in 10 yr 3 mo | Product |
| 9782376 | Dec 01, 2036 | in 10 yr 7 mo | Product |
| 11135190 | Dec 01, 2036 | in 10 yr 7 mo | Product |
| 10398669 | Dec 01, 2036 | in 10 yr 7 mo | Product |
| 11096913 | Feb 28, 2037 | in 10 yr 10 mo | Product |
| 10537538 | Feb 28, 2037 | in 10 yr 10 mo | Product |
| 10406108 | Mar 23, 2038 | in 11 yr 11 mo | Product |
| 10231931 | Mar 23, 2038 | in 11 yr 11 mo | Product |
| 11241382 | Sep 17, 2039 | in 13 yr 5 mo | U-3757 |
| 12564565 | Sep 26, 2044 | in 18 yr 6 mo | Product |
Levothyroxine sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
