FDA Orange Book · active-ingredient family
Abacavir sulfate
Abacavir sulfate is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZIAGEN · NDA 020978
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ABACAVIR SULFATE | AUROBINDO PHARMA LTD | ANDA 077950 | AA | Mar 14, 2018 | |
| ABACAVIR SULFATE | CIPLA | ANDA 078119 | AB | Nov 21, 2017 | |
| ABACAVIR SULFATE | CHARTWELL RX | ANDA 091050 | AB | Oct 28, 2016 | |
| ABACAVIR SULFATE | HETERO LABS LTD III | ANDA 201107 | AA | Sep 26, 2016 | |
| ABACAVIR SULFATE | HETERO LABS LTD III | ANDA 091560 | AB | Sep 13, 2013 | |
| ABACAVIR SULFATE | APOTEX INC | ANDA 201570 | — | Dec 17, 2012 | |
| ABACAVIR SULFATE | AUROBINDO PHARMA LTD | ANDA 077844 | AB | Dec 17, 2012 | |
| ABACAVIR SULFATE | MYLAN PHARMS INC | ANDA 091294 | AB | Jun 18, 2012 |
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.
Abacavir sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
