FDA Orange Book · active-ingredient family
Telavancin hydrochloride
Telavancin hydrochloride: 1 brand, 0 generics; first approved Sep 11, 2009; on patent until Jan 01, 2027.
On patentHas discontinued products
Generic status & protection
Protected until Jan 01, 2027 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Jan 01, 2027
in 4 mo
Brand (NDA) products
Originator applications
- VIBATIVRLDCUMBERLANDNDA 02211020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL POWDER INTRAVENOUS Discontinued — EQ 750MG BASE/VIAL POWDER INTRAVENOUS Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7531623 | in 4 mo | Substance |
Approval history
FDA approval span
First approval
17 yr 2 mo ago
Most recent approval
17 yr 2 mo ago
All 1 application were approved in 2009.
Brand (NDA) 1100%
Generic (ANDA) 00%
Telavancin hydrochloride: 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
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- 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.
