Is there a generic for Ganciclovir?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ganciclovir, referencing the brand GANZYK-RTU. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ganciclovir?

GANZYK-RTU (NDA 209347, EXELA PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ganciclovir?

The Orange Book lists 1 patent against Ganciclovir products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ganciclovir are approved?

Ganciclovir is approved in the following dosage forms: capsule, gel, implant, solution.

FDA Orange Book · active-ingredient family

Ganciclovir

Ganciclovir: 4 brands, 1 generic; first approved Dec 22, 1994; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Sep 02, 2034

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 02, 2034

in 8 yr

Brand (NDA) products

Originator applications

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GANZYK-RTURLD
EXELA PHARMANDA 2093472017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG/250ML (2MG/ML) SOLUTION INTRAVENOUS Discontinued -
ZIRGANRLDRS
BAUSCH AND LOMBNDA 0222112009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% GEL OPHTHALMIC Rx -
CYTOVENERLD
ROCHE PALONDA 02046019942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG CAPSULE ORAL Discontinued -
500MG CAPSULE ORAL Discontinued -
VITRASERT
BAUSCH AND LOMBNDA 0205691996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4.5MG IMPLANT IMPLANTATION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/250ML (2MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	GEL	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	-
500MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4.5MG	IMPLANT	IMPLANTATION	Discontinued	-

Generic (ANDA) products (1)

Abbreviated applications

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GANCICLOVIR
RANBAXY LABS LTDANDA 07645720032 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG CAPSULE ORAL Discontinued -
500MG CAPSULE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	CAPSULE	ORAL	Discontinued	-
500MG	CAPSULE	ORAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9486530	Sep 02, 2034	in 8 yr	Product

Approval history

FDA approval span

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First approval

Dec 22, 1994

32 yr 4 mo ago

Most recent approval

Feb 17, 2017

9 yr 10 mo ago

Approvals span 1994–2017 across 5 FDA applications.

Brand (NDA) 480%

Generic (ANDA) 120%

Ganciclovir: 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.

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Key facts