FDA Orange Book
Generic for Hycamtin
Hycamtin contains topotecan. 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 Hycamtin is topotecan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Hycamtin products the Orange Book lists.
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Hycamtin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.25MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| injectable, injection | EQ 4MG BASE/VIAL | Marketed (Rx) | AP | 7 | AP |
NDA 020981, 020671, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic topotecan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 091089 | AP (A-rated, therapeutically equivalent) | November 29, 2010 | EQ 4MG BASE/VIAL |
| TEYRO LABS PRIVATE LTD | 091199 | AP (A-rated, therapeutically equivalent) | December 1, 2010 | EQ 4MG BASE/VIAL |
| ACTAVIS TOTOWA LLC | 090620 | AP (A-rated, therapeutically equivalent) | December 2, 2010 | EQ 4MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 091284 | AP (A-rated, therapeutically equivalent) | January 26, 2011 | EQ 4MG BASE/VIAL |
| DR REDDYS LABORATORIES LTD | 201191 | AP (A-rated, therapeutically equivalent) | March 9, 2011 | EQ 4MG BASE/VIAL |
| ACCORD HEALTHCARE INC | 202351 | AP (A-rated, therapeutically equivalent) | June 26, 2013 | EQ 4MG BASE/VIAL |
| INGENUS PHARMACEUTICALS LLC | 206962 | AP (A-rated, therapeutically equivalent) | November 30, 2016 | EQ 4MG BASE/VIAL |
Hycamtin NDC codes
Questions
Is there a generic for Hycamtin?
Yes. The generic name for Hycamtin is topotecan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Hycamtin products the Orange Book lists.
What is the generic name for Hycamtin?
The active ingredient in Hycamtin is topotecan, per the FDA Orange Book.
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.