FDA Orange Book · active-ingredient family
Acarbose
Acarbose is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRECOSE · NDA 020482
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRECOSERLD×3 | BAYER HLTHCARE | NDA 020482 | — | May 29, 1997 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACARBOSE×3 | HANGZHOU ZHONGMEI | ANDA 213821 | — | Aug 18, 2020 | |
| ACARBOSE×3 | SOMERSET THERAPS LLC | ANDA 091343 | AB | Oct 17, 2013 | |
| ACARBOSE×3 | AVET LIFESCIENCES | ANDA 202271 | AB | Feb 07, 2012 | |
| ACARBOSE×3 | STRIDES PHARMA | ANDA 090912 | AB | Jul 27, 2011 | |
| ACARBOSE×3 | NATCO PHARMA USA | ANDA 091053 | — | Jan 06, 2011 | |
| ACARBOSE×3 | IMPAX LABS | ANDA 078441 | AB | May 14, 2009 | |
| ACARBOSE×3 | HIKMA | ANDA 078470 | AB | May 07, 2008 | |
| ACARBOSE×3 | WATSON LABS | ANDA 077532 | AB | May 07, 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.
Acarbose — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
