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
Brands (NDA)
4
Generics (ANDA)
1
Listed patents
1
Next patent expiry
Sep 02, 2034
in 8 yr
Brand (NDA) products
Originator applications
- GANZYK-RTURLDEXELA PHARMANDA 2093472017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/250ML (2MG/ML) SOLUTION INTRAVENOUS Discontinued — - BAUSCH AND LOMBNDA 0222112009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15% GEL OPHTHALMIC Rx — - CYTOVENERLDROCHE PALONDA 02046019942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - BAUSCH AND LOMBNDA 0205691996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4.5MG IMPLANT IMPLANTATION Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- GANCICLOVIRRANBAXY LABS LTDANDA 07645720032 strengths
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
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9486530 | in 8 yr | Product |
Approval history
FDA approval span
First approval
32 yr 3 mo ago
Most recent approval
9 yr 9 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.
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.
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