FDA Orange Book
Generic for Dilaudid-hp
Dilaudid-hp contains hydromorphone. 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 Dilaudid-hp is hydromorphone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Dilaudid-hp products the Orange Book lists.
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Dilaudid-hp products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Marketed (Rx) | AP | 3 | AP |
| injectable, injection | 250MG/VIAL | Discontinued | None | 0 | None |
NDA 019034, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydromorphone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 078591 | AP (A-rated, therapeutically equivalent) | June 17, 2008 | 10MG/ML |
| RISING PHARMA HOLDINGS INC | 078228 | AP (A-rated, therapeutically equivalent) | April 14, 2010 | 10MG/ML |
| RISING PHARMA HOLDINGS INC | 078261 | AP (A-rated, therapeutically equivalent) | April 14, 2010 | 10MG/ML |
Dilaudid-hp patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9731082 | April 23, 2032 | Drug product | None | 019034 |
| 9248229 | March 12, 2034 | Drug product | None | 019034 |
Dilaudid-hp NDC codes
Questions
Is there a generic for Dilaudid-hp?
Yes. The generic name for Dilaudid-hp is hydromorphone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Dilaudid-hp products the Orange Book lists.
What is the generic name for Dilaudid-hp?
The active ingredient in Dilaudid-hp is hydromorphone, per the FDA Orange Book.
When does the Dilaudid-hp patent expire?
The last patent listed for Dilaudid-hp in the Orange Book expires March 12, 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.