FDA Orange Book · active-ingredient family
Dofetilide
Dofetilide is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TIKOSYN · NDA 020931
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIKOSYNRLD×3 | PFIZER | NDA 020931 | AB | Oct 01, 1999 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOFETILIDE×3 | TEVA PHARMS USA | ANDA 210018 | — | Apr 15, 2022 | |
| DOFETILIDE×3 | RK PHARMA | ANDA 215323 | — | Apr 14, 2022 | |
| DOFETILIDE×3 | GRANULES | ANDA 212750 | AB | Oct 14, 2021 | |
| DOFETILIDE×3 | ACCORD HLTHCARE | ANDA 213338 | AB | Jun 19, 2020 | |
| DOFETILIDE×3 | MSN | ANDA 213220 | AB | Jan 29, 2020 | |
| DOFETILIDE×3 | INGENUS PHARMS LLC | ANDA 212410 | — | Dec 27, 2019 | |
| DOFETILIDE×3 | PRINSTON INC | ANDA 211223 | — | Dec 17, 2019 | |
| DOFETILDE×3 | AUROBINDO PHARMA LTD | ANDA 210740 | AB | Jan 22, 2019 | |
| DOFETILIDE×3 | STRIDES PHARMA INTL | ANDA 208519 | — | Oct 09, 2018 | |
| DOFETILIDE×3 | SUN PHARM | ANDA 210466 | AB | Oct 09, 2018 | |
| DOFETILIDE×3 | BIONPHARMA | ANDA 208625 | AB | Apr 10, 2018 | |
| DOFETILIDE×3 | SIGMAPHARM LABS LLC | ANDA 207746 | AB | Mar 26, 2018 | |
| DOFETILIDE×3 | DR REDDYS LABS SA | ANDA 207058 | AB | Jun 06, 2016 |
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.
Dofetilide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
