FDA Orange Book · active-ingredient family
Allopurinol
Allopurinol is approved as 6 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYLOPRIM · NDA 016084
6
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYLOPRIMRLD×3 | CASPER PHARMA LLC | NDA 016084 | AB | Approved Prior to Jan 1, 1982 | |
| ALLOPURINOL×2 | WATSON LABS | NDA 018241 | — | Nov 16, 1984 | |
| ALLOPURINOL×2 | WATSON LABS | NDA 018785 | — | Sep 28, 1984 | |
| ALLOPURINOL | WATSON LABS | NDA 018832 | AB | Sep 28, 1984 | |
| ALLOPURINOL | WATSON LABS | NDA 018877 | AB | Sep 28, 1984 | |
| LOPURIN×2 | ABBOTT | NDA 018297 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALLOPURINOL×2 | AUROBINDO PHARMA LTD | ANDA 215091 | AB | Apr 14, 2025 | |
| ALLOPURINOL×2 | LUPIN | ANDA 211807 | — | Dec 14, 2023 | |
| ALLOPURINOL×2 | HETERO LABS LTD V | ANDA 217748 | AB | Aug 03, 2023 | |
| ALLOPURINOL×3 | HARMAN FINOCHEM | ANDA 214443 | AB | Mar 07, 2022 | |
| ALLOPURINOL×2 | UNICHEM | ANDA 211820 | AB | Mar 12, 2019 | |
| ALLOPURINOL×3 | ZYDUS PHARMS | ANDA 210117 | AB | Oct 12, 2017 | |
| ALLOPURINOL×3 | REGCON HOLDINGS | ANDA 204467 | AB | Jul 28, 2016 | |
| ALLOPURINOL×2 | ACCORD HLTHCARE | ANDA 203154 | AB | May 06, 2013 | |
| ALLOPURINOL×2 | IPCA LABS LTD | ANDA 090637 | — | Mar 16, 2011 | |
| ALLOPURINOL×2 | NORTHSTAR HLTHCARE | ANDA 078253 | — | Sep 11, 2007 | |
| ALLOPURINOL×2 | SUN PHARM INDS INC | ANDA 078390 | — | Aug 30, 2007 | |
| ALLOPURINOL×2 | CHARTWELL | ANDA 077353 | AB | Sep 08, 2005 | |
| ALLOPURINOL×2 | PH HEALTH | ANDA 075798 | AB | Jun 27, 2003 | |
| ALLOPURINOL | SUPERPHARM | ANDA 070950 | — | Nov 30, 1988 | |
| ALLOPURINOL | SUPERPHARM | ANDA 070951 | — | Nov 30, 1988 | |
| LOPURIN | DR REDDYS | ANDA 071586 | AB | Apr 02, 1987 | |
| LOPURIN | DR REDDYS | ANDA 071587 | AB | Apr 02, 1987 | |
| ALLOPURINOL×2 | SUN PHARM INDUSTRIES | ANDA 071450 | AB | Jan 09, 1987 | |
| ALLOPURINOL×2 | MYLAN | ANDA 018659 | AB | Oct 24, 1986 | |
| ALLOPURINOL | PUREPAC PHARM | ANDA 070579 | — | Apr 14, 1986 | |
| ALLOPURINOL | PUREPAC PHARM | ANDA 070580 | — | Apr 14, 1986 | |
| ALLOPURINOL | AIPING PHARM INC | ANDA 070268 | — | Dec 31, 1985 | |
| ALLOPURINOL | SANDOZ | ANDA 070269 | — | Dec 31, 1985 | |
| ALLOPURINOL | MUTUAL PHARM | ANDA 070466 | — | Dec 24, 1985 | |
| ALLOPURINOL | MUTUAL PHARM | ANDA 070467 | — | Dec 24, 1985 | |
| ALLOPURINOL | PURACAP PHARM | ANDA 070150 | — | Dec 10, 1985 | |
| ALLOPURINOL | PURACAP PHARM | ANDA 070147 | — | Dec 10, 1985 |
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.
Allopurinol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
