FDA Orange Book · active-ingredient family
Alendronate sodium
Alendronate sodium: 3 brands, 16 generics; first approved Sep 29, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
1
Next patent expiry
Dec 05, 2031
in 5 yr 5 mo
Brand (NDA) products
Originator applications
- BINOSTORLDRADIUSNDA 2023442012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE TABLET, EFFERVESCENT ORAL Discontinued — - FOSAMAXRLDMERCKNDA 0215752003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE/75ML SOLUTION ORAL Discontinued — - FOSAMAXRLDORGANONNDA 02056019975 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — EQ 5MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (16)
Abbreviated applications
- ALENDRONATE SODIUMIPCA LABS LTDANDA 20638720244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 35MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMNOVITIUM PHARMAANDA 2145122023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE/75ML SOLUTION ORAL Rx AA - ALENDRONATE SODIUMRSHIKMAANDA 0905202013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE/75ML SOLUTION ORAL Rx AA - ALENDRONATE SODIUMJUBILANT CADISTAANDA 09055720104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMHANGZHOU BINJIANGANDA 09025820094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 35MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMCHARTWELL RXANDA 07587120095 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMSUN PHARMANDA 09002220084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 35MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMAPOTEXANDA 07798220084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMAUROBINDO PHARMAANDA 09012420083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 35MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMCHARTWELL RXANDA 07904920084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMCIPLAANDA 07676820085 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 35MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMMYLANANDA 07863820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMRISINGANDA 07658420084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMTEVA PHARMSANDA 07618420082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — - ALENDRONATE SODIUMWATSON LABSANDA 07698420083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 35MG BASE TABLET ORAL Rx AB EQ 40MG BASE TABLET ORAL Rx AB EQ 70MG BASE TABLET ORAL Rx AB - ALENDRONATE SODIUMIMPAX LABS INCANDA 07571020085 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 35MG BASE TABLET ORAL Discontinued — EQ 40MG BASE TABLET ORAL Discontinued — EQ 70MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9592195 | in 5 yr 5 mo | Product |
Approval history
FDA approval span
First approval
31 yr 4 mo ago
Most recent approval
2 yr 3 mo ago
Approvals span 1995–2024 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Alendronate 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.
