FDA Orange Book
Generic for Isentress Hd
Isentress Hd contains raltegravir. 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 Isentress Hd is raltegravir. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Isentress Hd products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 600MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 022145, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic raltegravir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 217990 | AB (A-rated, therapeutically equivalent) | May 6, 2025 | EQ 600MG BASE |
Isentress Hd patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7754731 | March 11, 2029 | Drug substance, Drug product | U-257 | 022145 |
| 7754731*PED | September 11, 2029 | Method of use | None | 022145 |
| 8771733 | June 2, 2030 | Drug substance, Drug product | U-257 | 022145 |
| 9649311 | October 21, 2030 | Drug product | None | 022145 |
| 9649311*PED | April 21, 2031 | Method of use | None | 022145 |
| 10772888 | March 30, 2032 | Method of use | U-1663 | 022145 |
Isentress Hd NDC codes
Questions
Is there a generic for Isentress Hd?
Yes. The generic name for Isentress Hd is raltegravir. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Isentress Hd?
The active ingredient in Isentress Hd is raltegravir, per the FDA Orange Book.
When does the Isentress Hd patent expire?
The last patent listed for Isentress Hd in the Orange Book expires March 30, 2032. 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.