FDA Orange Book · active-ingredient family
Capecitabine
Capecitabine is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XELODA · NDA 020896
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XELODARLD×2 | CHEPLAPHARM | NDA 020896 | — | Apr 30, 1998 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAPECITABINE×2 | HETERO LABS LTD V | ANDA 210203 | AB | Mar 05, 2024 | |
| CAPECITABINE×2 | TEYRO LABS | ANDA 217237 | BX | Oct 23, 2023 | |
| CAPECITABINE×2 | DR REDDYS | ANDA 204345 | AB | Dec 04, 2020 | |
| CAPECITABINE×2 | RELIANCE LIFE | ANDA 211724 | AB | Apr 27, 2020 | |
| CAPECITABINE×2 | SUN PHARM | ANDA 204668 | — | Jun 21, 2019 | |
| CAPECITABINE×2 | MSN | ANDA 209365 | AB | Jul 02, 2018 | |
| CAPECITABINE×2 | EUGIA PHARMA | ANDA 210604 | AB | Apr 17, 2018 | |
| CAPECITABINE×2 | ALKEM LABS LTD | ANDA 207652 | AB | Nov 24, 2017 | |
| CAPECITABINE×2 | AMNEAL PHARMS | ANDA 204741 | — | Feb 28, 2017 | |
| CAPECITABINE×2 | SHILPA | ANDA 207456 | AB | Dec 12, 2016 | |
| CAPECITABINE×2 | HIKMA | ANDA 200483 | — | Jul 14, 2016 | |
| CAPECITABINE×2 | ACCORD HLTHCARE | ANDA 202593 | AB | Apr 23, 2015 | |
| CAPECITABINE×2 | RISING | ANDA 090943 | AB | Aug 08, 2014 | |
| CAPECITABINE×2 | TEVA PHARMS USA | ANDA 091649 | AB | Sep 16, 2013 |
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.
Capecitabine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
