Is there a generic for Adefovir dipivoxil?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Adefovir dipivoxil, referencing the brand HEPSERA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Adefovir dipivoxil?

HEPSERA (NDA 021449, GILEAD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Adefovir dipivoxil are approved?

Adefovir dipivoxil is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Adefovir dipivoxil

Adefovir dipivoxil is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HEPSERA · NDA 021449

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
HEPSERARLD	GILEAD	NDA 021449	—	Sep 20, 2002

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
ADEFOVIR DIPIVOXIL	APOTEX	ANDA 205459	AB	Jul 06, 2018
ADEFOVIR DIPIVOXIL	SIGMAPHARM LABS LLC	ANDA 202051	AB	Aug 29, 2013

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.

Adefovir dipivoxil — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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