FDA Orange Book · active-ingredient family
Ibandronate sodium
Ibandronate sodium is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BONIVA · NDA 021858
2
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BONIVARLD | ROCHE | NDA 021858 | — | Jan 06, 2006 | |
| BONIVARLD×2 | HOFFMANN LA ROCHE | NDA 021455 | — | May 16, 2003 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBANDRONATE SODIUM | NANG KUANG PHARM CO | ANDA 204329 | — | Jun 16, 2021 | |
| IBANDRONATE SODIUM | MACLEODS PHARMS LTD | ANDA 206887 | AB | Oct 31, 2017 | |
| IBANDRONATE SODIUM | AUROBINDO PHARMA | ANDA 204502 | AB | Mar 11, 2016 | |
| IBANDRONATE SODIUM | ACCORD HLTHCARE | ANDA 206058 | AP | Feb 05, 2016 | |
| IBANDRONATE SODIUM | APOTEX | ANDA 204222 | AP | Oct 16, 2015 | |
| IBANDRONATE SODIUM | EUGIA PHARMA | ANDA 205332 | AP | Aug 19, 2015 | |
| IBANDRONATE SODIUM | AVET LIFESCIENCES | ANDA 203987 | — | Sep 02, 2014 | |
| IBANDRONATE SODIUM | CHEMI SPA | ANDA 202235 | — | Sep 02, 2014 | |
| IBANDRONATE SODIUM | PHARMOBEDIENT | ANDA 202671 | AP | Sep 02, 2014 | |
| IBANDRONATE SODIUM | SUN PHARM | ANDA 090853 | — | Feb 14, 2014 | |
| IBANDRONATE SODIUM | SUN PHARM INDUSTRIES | ANDA 078996 | — | Aug 15, 2012 | |
| IBANDRONATE SODIUM | DR REDDYS LABS LTD | ANDA 078997 | AB | Apr 30, 2012 | |
| IBANDRONATE SODIUM | WATSON LABS TEVA | ANDA 079003 | — | Mar 20, 2012 | |
| IBANDRONATE SODIUM | APOTEX INC | ANDA 078948 | AB | Mar 19, 2012 | |
| IBANDRONATE SODIUM | ORBION PHARMS | ANDA 078998 | AB | Mar 19, 2012 | |
| IBANDRONATE SODIUM | PHARMOBEDIENT | ANDA 078995 | — | Mar 19, 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.
Ibandronate sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
