FDA Orange Book · active-ingredient family
Zaleplon
Zaleplon is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SONATA · NDA 020859
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SONATARLD×2 | PFIZER | NDA 020859 | — | Aug 13, 1999 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZALEPLON×2 | ORBION PHARMS | ANDA 090374 | AB | Sep 17, 2009 | |
| ZALEPLON×2 | HIKMA PHARMS | ANDA 078147 | — | Nov 25, 2008 | |
| ZALEPLON×2 | CHARTWELL MOLECULAR | ANDA 077505 | AB | Jun 20, 2008 | |
| ZALEPLON×2 | AUROBINDO PHARMA | ANDA 078829 | AB | Jun 06, 2008 | |
| ZALEPLON×2 | HIKMA | ANDA 077237 | AB | Jun 06, 2008 | |
| ZALEPLON×2 | NATCO PHARMA | ANDA 077238 | — | Jun 06, 2008 | |
| ZALEPLON×2 | TEVA PHARMS | ANDA 077239 | — | Jun 06, 2008 | |
| ZALEPLON×2 | UNICHEM | ANDA 078989 | AB | Jun 06, 2008 | |
| ZALEPLON×2 | UPSHER SMITH LABS | ANDA 078095 | — | Jun 06, 2008 | |
| ZALEPLON×2 | UPSHER SMITH LABS | ANDA 078706 | — | Jun 06, 2008 |
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.
Zaleplon — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
