FDA Orange Book · active-ingredient family
Ibandronate sodium
Ibandronate sodium: 2 brands, 16 generics; first approved May 16, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
16
Listed patents
0
Presentations
19
Brand (NDA) products
Originator applications
- BONIVARLDROCHENDA 0218582006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - BONIVARLDHOFFMANN LA ROCHENDA 02145520032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE TABLET ORAL Discontinued — EQ 150MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- IBANDRONATE SODIUMNANG KUANG PHARM COANDA 2043292021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - IBANDRONATE SODIUMMACLEODS PHARMSANDA 2068872017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Rx AB - IBANDRONATE SODIUMAUROBINDO PHARMAANDA 2045022016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Rx AB - IBANDRONATE SODIUMACCORD HLTHCAREANDA 2060582016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Rx AP - IBANDRONATE SODIUMRSAPOTEXANDA 2042222015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Rx AP - IBANDRONATE SODIUMEUGIA PHARMAANDA 2053322015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Rx AP - IBANDRONATE SODIUMAVET LIFESCIENCESANDA 2039872014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - IBANDRONATE SODIUMCHEMI SPAANDA 2022352014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - IBANDRONATE SODIUMPHARMOBEDIENTANDA 2026712014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - IBANDRONATE SODIUMSUN PHARMANDA 0908532014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/3ML INJECTABLE INTRAVENOUS Discontinued — - IBANDRONATE SODIUMSUN PHARM INDUSTRIESANDA 0789962012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Discontinued — - IBANDRONATE SODIUMRSDR REDDYS LABS LTDANDA 0789972012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Rx AB - IBANDRONATE SODIUMWATSON LABS TEVAANDA 0790032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Discontinued — - IBANDRONATE SODIUMAPOTEX INCANDA 0789482012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Rx AB - IBANDRONATE SODIUMORBION PHARMSANDA 0789982012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Rx AB - IBANDRONATE SODIUMPHARMOBEDIENTANDA 0789952012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
23 yr 9 mo ago
Most recent approval
5 yr 5 mo ago
Approvals span 2003–2021 across 18 FDA applications.
Brand (NDA) 211%
Generic (ANDA) 1689%
Ibandronate sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
