FDA Orange Book

Is there a generic for Loreev XR?

Loreev XR contains lorazepam. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Loreev XR (lorazepam). The Orange Book shows its last listed patent expires January 8, 2034.

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Loreev XR products in the Orange Book

Loreev XR products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral1.5MGMarketed (Rx)None0None
capsule, extended release, oral1MGMarketed (Rx)None0None
capsule, extended release, oral2MGMarketed (Rx)None0None
capsule, extended release, oral3MGMarketed (Rx)None0None

NDA 214826, held by ALMATICA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Loreev XR patents

Patents listed for Loreev XR
PatentExpiresCoversUse codeNDA
8999393January 8, 2034Drug productU-3210214826

Loreev XR NDC codes

Questions

Is there a generic for Loreev XR?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Loreev XR (lorazepam). The Orange Book shows its last listed patent expires January 8, 2034.

What is the generic name for Loreev XR?

The active ingredient in Loreev XR is lorazepam, per the FDA Orange Book.

When does the Loreev XR patent expire?

The last patent listed for Loreev XR in the Orange Book expires January 8, 2034. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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