FDA Orange Book · active-ingredient family
Caffeine citrate
Caffeine citrate 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:CAFCIT · NDA 020793
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAFCITRLD×2 | HIKMA | NDA 020793 | AP | Sep 21, 1999 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAFFEINE CITRATE | MICRO LABS | ANDA 213202 | AA | Dec 16, 2019 | |
| CAFFEINE CITRATE | MICRO LABS | ANDA 207400 | AP | Dec 14, 2017 | |
| CAFFEINE CITRATE | EUGIA PHARMA | ANDA 205013 | — | Sep 22, 2015 | |
| CAFFEINE CITRATE | SAGENT PHARMS | ANDA 090827 | AP | Aug 29, 2012 | |
| CAFFEINE CITRATE | SAGENT PHARMS | ANDA 091102 | AA | Aug 29, 2012 | |
| CAFFEINE CITRATE | AM REGENT | ANDA 090064 | — | Nov 20, 2009 | |
| CAFFEINE CITRATE | SUN PHARM | ANDA 090077 | — | Sep 30, 2009 | |
| CAFFEINE CITRATE | SUN PHARM | ANDA 090357 | — | Sep 30, 2009 | |
| CAFFEINE CITRATE | FRESENIUS KABI USA | ANDA 078002 | AA | Jan 31, 2008 | |
| CAFFEINE CITRATE | FRESENIUS KABI USA | ANDA 077997 | AP | Jul 20, 2007 | |
| CAFFEINE CITRATE | AM REGENT | ANDA 077906 | AP | May 15, 2007 | |
| CAFFEINE CITRATE | EXELA PHARMA SCIENCE | ANDA 077233 | AP | Sep 21, 2006 | |
| CAFFEINE CITRATE | EXELA PHARMA | ANDA 077304 | AA | Sep 21, 2006 |
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.
Caffeine citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
