FDA Orange Book
Generic for Immphentiv
Immphentiv contains phenylephrine. 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
Yes. The generic name for Immphentiv is phenylephrine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Immphentiv products the Orange Book lists.
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Immphentiv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 0.5MG/5ML (0.1MG/ML) | Marketed (Rx) | None | 1 | AP |
| solution, intravenous | 1MG/10ML (0.1MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 203826, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic phenylephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SOMERSET THERAPEUTICS LLC | 215617 | AP (A-rated, therapeutically equivalent) | February 14, 2025 | 0.5MG/5ML (0.1MG/ML) |
Immphentiv patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11471400 | August 5, 2036 | Drug product | None | 203826 |
| 11213480 | September 26, 2036 | Drug product | None | 203826 |
| 12257342 | September 26, 2036 | Drug product | None | 203826 |
Immphentiv NDC codes
Questions
Is there a generic for Immphentiv?
Yes. The generic name for Immphentiv is phenylephrine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Immphentiv products the Orange Book lists.
What is the generic name for Immphentiv?
The active ingredient in Immphentiv is phenylephrine, per the FDA Orange Book.
When does the Immphentiv patent expire?
The last patent listed for Immphentiv in the Orange Book expires September 26, 2036. 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.