FDA Orange Book · active-ingredient family
Adefovir dipivoxil
Adefovir dipivoxil: 1 brand, 2 generics; first approved Sep 20, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- HEPSERARLDGILEADNDA 0214492002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- ADEFOVIR DIPIVOXILAPOTEXANDA 2054592018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - ADEFOVIR DIPIVOXILRSSIGMAPHARM LABS LLCANDA 2020512013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB
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
24 yr 3 mo ago
Most recent approval
8 yr 3 mo ago
Approvals span 2002–2018 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Adefovir dipivoxil: 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.
