FDA Orange Book

Is there a generic for Kapspargo Sprinkle?

Kapspargo Sprinkle contains metoprolol. 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 Kapspargo Sprinkle (metoprolol). The Orange Book shows its last listed patent expires July 9, 2035.

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Kapspargo Sprinkle products in the Orange Book

Kapspargo Sprinkle products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oralEQ 100MG TARTRATEMarketed (Rx)None0None
capsule, extended release, oralEQ 200MG TARTRATEMarketed (Rx)None0None
capsule, extended release, oralEQ 25MG TARTRATEMarketed (Rx)None0None
capsule, extended release, oralEQ 50MG TARTRATEMarketed (Rx)None0None

NDA 210428, held by SUN PHARMA INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Kapspargo Sprinkle patents

Patents listed for Kapspargo Sprinkle
PatentExpiresCoversUse codeNDA
9504655July 9, 2035Drug productNone210428
9700530July 9, 2035Drug productNone210428

Kapspargo Sprinkle NDC codes

Questions

Is there a generic for Kapspargo Sprinkle?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Kapspargo Sprinkle (metoprolol). The Orange Book shows its last listed patent expires July 9, 2035.

What is the generic name for Kapspargo Sprinkle?

The active ingredient in Kapspargo Sprinkle is metoprolol, per the FDA Orange Book.

When does the Kapspargo Sprinkle patent expire?

The last patent listed for Kapspargo Sprinkle in the Orange Book expires July 9, 2035. 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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