FDA Orange Book
Generic for Isentress
Isentress 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 is raltegravir. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 4 Isentress products the Orange Book lists.
Run it in Rivvi
Map Isentress and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Isentress products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | EQ 100MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, chewable, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, chewable, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 400MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 205786, 203045, 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 |
|---|---|---|---|---|
| HETERO LABS LTD UNIT III | 203540 | AB (A-rated, therapeutically equivalent) | December 19, 2024 | EQ 400MG BASE |
Isentress patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8852632 | January 28, 2028 | Drug substance, Drug product | U-257 | 022145 |
| 7754731 | March 11, 2029 | Drug substance, Drug product | U-257 | 205786 |
| 7754731*PED | September 11, 2029 | Method of use | None | 205786 |
| 8771733 | June 2, 2030 | Drug substance, Drug product | U-257 | 203045 |
Isentress NDC codes
Questions
Is there a generic for Isentress?
Yes. The generic name for Isentress is raltegravir. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 4 Isentress products the Orange Book lists.
What is the generic name for Isentress?
The active ingredient in Isentress is raltegravir, per the FDA Orange Book.
When does the Isentress patent expire?
The last patent listed for Isentress in the Orange Book expires June 2, 2030. 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.
More on Isentress and Raltegravir
- What is Isentress used for?FDA label uses
- Is Isentress a controlled substance?Federal schedule
- What is Raltegravir used for?FDA label uses
- Is Raltegravir a controlled substance?Federal schedule
- Generic for Isentress HdFDA Orange Book
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- NDC 0006-0227Isentress NDC record
- NDC 0006-0473Isentress NDC record
- NDC 0006-0477Isentress NDC record