FDA Orange Book
Generic for Tikosyn
Tikosyn contains dofetilide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tikosyn is dofetilide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Tikosyn and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Tikosyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.125MG | Marketed (Rx) | AB | 9 | AB |
| capsule, oral | 0.25MG | Marketed (Rx) | AB | 9 | AB |
| capsule, oral | 0.5MG | Marketed (Rx) | AB | 9 | AB |
NDA 020931, held by PFIZER PHARMACEUTICALS PRODUCTION CORP LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dofetilide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 207058 | AB (A-rated, therapeutically equivalent) | June 6, 2016 | 0.125MG, 0.25MG, 0.5MG |
| SIGMAPHARM LABORATORIES LLC | 207746 | AB (A-rated, therapeutically equivalent) | March 26, 2018 | 0.125MG, 0.25MG, 0.5MG |
| BIONPHARMA INC | 208625 | AB (A-rated, therapeutically equivalent) | April 10, 2018 | 0.125MG, 0.25MG, 0.5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 210466 | AB (A-rated, therapeutically equivalent) | October 9, 2018 | 0.125MG, 0.25MG, 0.5MG |
| AUROBINDO PHARMA LTD | 210740 | AB (A-rated, therapeutically equivalent) | January 22, 2019 | 0.125MG, 0.25MG, 0.5MG |
| MSN LABORATORIES PRIVATE LTD | 213220 | AB (A-rated, therapeutically equivalent) | January 29, 2020 | 0.125MG, 0.25MG, 0.5MG |
| ACCORD HEALTHCARE INC | 213338 | AB (A-rated, therapeutically equivalent) | June 19, 2020 | 0.125MG, 0.25MG, 0.5MG |
| GRANULES PHARMACEUTICALS INC | 212750 | AB (A-rated, therapeutically equivalent) | October 14, 2021 | 0.125MG, 0.25MG, 0.5MG |
| ANDAS 5 HOLDING LLC | 212496 | AB (A-rated, therapeutically equivalent) | July 29, 2026 | 0.125MG, 0.25MG, 0.5MG |
Tikosyn NDC codes
Questions
Is there a generic for Tikosyn?
Yes. The generic name for Tikosyn is dofetilide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Tikosyn?
The active ingredient in Tikosyn is dofetilide, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.