FDA Orange Book · active-ingredient family
Adenosine
Adenosine is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADENOSCAN · NDA 020059
2
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADENOSCANRLD×2 | ASTELLAS | NDA 020059 | — | May 18, 1995 | |
| ADENOCARDRLD | ASTELLAS | NDA 019937 | — | Oct 30, 1989 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADENOSINE | FRESENIUS KABI USA | ANDA 205568 | AP | Apr 16, 2018 | |
| ADENOSINE | GLAND | ANDA 206778 | AP | Feb 16, 2018 | |
| ADENOSINE×2 | FRESENIUS KABI USA | ANDA 077897 | AP | Nov 27, 2017 | |
| ADENOSINE×2 | EUGIA PHARMA | ANDA 205331 | AP | Nov 02, 2017 | |
| ADENOSINE×2 | RISING | ANDA 090450 | AP | Oct 02, 2014 | |
| ADENOSINE×2 | AVET LIFESCIENCES | ANDA 202313 | AP | Sep 15, 2014 | |
| ADENOSINE×2 | MYLAN ASI | ANDA 090212 | AP | Mar 28, 2014 | |
| ADENOSINE×2 | HOSPIRA | ANDA 203883 | — | Mar 24, 2014 | |
| ADENOSINE | PHARMOBEDIENT | ANDA 078640 | — | Mar 21, 2014 | |
| ADENOSINE×2 | MEITHEAL | ANDA 077425 | AP | Aug 29, 2013 | |
| ADENOSINE | WOCKHARDT | ANDA 090220 | — | Jul 20, 2009 | |
| ADENOSINE | MYLAN LABS LTD | ANDA 078686 | AP | May 13, 2009 | |
| ADENOSINE | AM REGENT | ANDA 090010 | — | Apr 28, 2009 | |
| ADENOSINE | RISING | ANDA 078076 | AP | Oct 31, 2008 | |
| ADENOSINE | TEVA PHARMS USA | ANDA 078676 | — | Jul 31, 2008 | |
| ADENOSINE | GLAND PHARMA LTD | ANDA 077283 | AP | Jun 14, 2007 | |
| ADENOSINE | FRESENIUS KABI USA | ANDA 077133 | AP | Apr 27, 2005 | |
| ADENOSINE | HIKMA | ANDA 076404 | AP | Jun 16, 2004 | |
| ADENOSINE | HIKMA | ANDA 076500 | AP | Jun 16, 2004 | |
| ADENOSINE | HIKMA | ANDA 076501 | — | Jun 16, 2004 | |
| ADENOSINE | TEVA PHARMS USA | ANDA 076564 | — | Jun 16, 2004 |
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.
Adenosine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
