FDA Orange Book

Is there a generic for neffy?

neffy contains epinephrine. 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 neffy (epinephrine). The Orange Book shows its last listed patent expires February 6, 2039.

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neffy products in the Orange Book

neffy products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
spray, nasal1MG/SPRAYMarketed (Rx)None0None
spray, nasal2MG/SPRAYMarketed (Rx)None0None

NDA 214697, held by ARS PHARMACEUTICALS OPERATIONS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

neffy patents

Patents listed for neffy
PatentExpiresCoversUse codeNDA
11173209February 6, 2038Method of useU-3979214697
10576156February 6, 2038Drug productNone214697
11918655February 6, 2039Method of useU-3979214697
11744895February 6, 2039Method of useU-3979214697
11717571February 6, 2039Method of useU-3979214697
11191838February 6, 2039Drug productU-3979214697
10682414February 6, 2039Method of useU-3979214697
12324838February 6, 2039Drug productNone214697

neffy NDC codes

Questions

Is there a generic for neffy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for neffy (epinephrine). The Orange Book shows its last listed patent expires February 6, 2039.

What is the generic name for neffy?

The active ingredient in neffy is epinephrine, per the FDA Orange Book.

When does the neffy patent expire?

The last patent listed for neffy in the Orange Book expires February 6, 2039. 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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