FDA Orange Book · active-ingredient family
Levocetirizine dihydrochloride
Levocetirizine dihydrochloride: 4 brands, 24 generics; first approved May 25, 2007; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
24
Listed patents
1
Next patent expiry
Oct 16, 2027
in 1 yr
Brand (NDA) products
Originator applications
- CHATTEM SANOFINDA 2090902017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL OTC — - CHATTEM SANOFINDA 2090892017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — - XYZALRLDCHATTEM SANOFINDA 0221572008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Discontinued — - XYZALRLDCHATTEM SANOFINDA 0220642007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (24)
Abbreviated applications
- LEVOCETIRIZINE DIHYDROCHLORIDEIPCA LABS LTDANDA 2046262024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEAPOTEXANDA 2114432021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEHETERO LABS LTD IIIANDA 2135132020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — - HETERO LABS LTD IIIANDA 2109142019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Rx AA - LEVOCETIRIZINE DIHYDROCHLORIDEPERRIGO R AND DANDA 2119832019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — - LEVOCETIRIZINE DIHYDROCHLORIDESANKALP LIFECAREANDA 2115512018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — - LEVOCETIRIZINE DIHYDROCHLORIDEDR REDDYSANDA 2103752018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — - LEVOCETIRIZINE DIHYDROCHLORIDECHARTWELL MOLECULARANDA 2045992017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Rx AA - LEVOCETIRIZINE DIHYDROCHLORIDEUS ANTIBIOTICSANDA 2043232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEMACLEODS PHARMSANDA 2055642016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDESUN PHARM INDS LTDANDA 2016532015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEAPOTEXANDA 2030272015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDESCIEGEN PHARMSANDA 2036462014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDEAPOTEXANDA 2029152014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEMICRO LABS LTD INDIAANDA 2020462013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDETAROANDA 2026732013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDEGRANULESANDA 0904862013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - LEVOCETIRIZINE DIHYDROCHLORIDESUN PHARMANDA 0903622013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDEHETERO LABS LTD IIIANDA 0912642012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDERSPADAGIS USANDA 0912632011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/5ML SOLUTION ORAL Rx AA - LEVOCETIRIZINE DIHYDROCHLORIDETEVA PHARMSANDA 0901992011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDEDR REDDYS LABS LTDANDA 0903922011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDERSGLENMARK PHARMS LTDANDA 0903852011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - LEVOCETIRIZINE DIHYDROCHLORIDESYNTHON BVANDA 0902292010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8633194 | in 1 yr | Product |
Approval history
FDA approval span
First approval
19 yr 8 mo ago
Most recent approval
2 yr 6 mo ago
Approvals span 2007–2024 across 28 FDA applications.
Brand (NDA) 414%
Generic (ANDA) 2486%
Levocetirizine dihydrochloride: 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.
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