FDA Orange Book

Is there a generic for Forfivo XL?

Forfivo XL contains bupropion. 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 Forfivo XL (bupropion). The Orange Book shows its last listed patent expires August 23, 2028.

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Forfivo XL products in the Orange Book

Forfivo XL products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, extended release, oral450MGMarketed (Rx)None0None

NDA 022497, held by TWI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Forfivo XL patents

Patents listed for Forfivo XL
PatentExpiresCoversUse codeNDA
7674479August 23, 2028Drug productNone022497

Forfivo XL NDC codes

Questions

Is there a generic for Forfivo XL?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Forfivo XL (bupropion). The Orange Book shows its last listed patent expires August 23, 2028.

What is the generic name for Forfivo XL?

The active ingredient in Forfivo XL is bupropion, per the FDA Orange Book.

When does the Forfivo XL patent expire?

The last patent listed for Forfivo XL in the Orange Book expires August 23, 2028. 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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