FDA Orange Book
Generic for Imitrex Statdose (autoinjector)
Imitrex Statdose (autoinjector) contains sumatriptan. 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 Imitrex Statdose (autoinjector) is sumatriptan. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Imitrex Statdose (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | Marketed (Rx) | AB | 1 | AB |
| solution, subcutaneous | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | Marketed (Rx) | AB | 11 | AP, AB |
NDA 020080, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sumatriptan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 079123 | AP (A-rated, therapeutically equivalent) | February 6, 2009 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| WOCKHARDT BIO AG | 078593 | AP (A-rated, therapeutically equivalent) | February 6, 2009 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| FRESENIUS KABI USA LLC | 079242 | AP (A-rated, therapeutically equivalent) | March 2, 2009 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090358 | AB (A-rated, therapeutically equivalent) | June 21, 2011 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 202758 | AP (A-rated, therapeutically equivalent) | April 23, 2013 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| HIKMA FARMACEUTICA PORTUGAL SA | 200183 | AP (A-rated, therapeutically equivalent) | September 16, 2013 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| DR REDDYS LABORATORIES INC | 090495 | AB (A-rated, therapeutically equivalent) | January 29, 2014 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| CAPLIN STERILES LTD | 213998 | AP (A-rated, therapeutically equivalent) | July 13, 2021 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| ONESOURCE SPECIALTY PTE LTD | 215651 | AP (A-rated, therapeutically equivalent) | November 21, 2024 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| ALEMBIC PHARMACEUTICALS LTD | 213518 | AB (A-rated, therapeutically equivalent) | November 6, 2025 | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML), EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| ONESOURCE SPECIALTY PTE LTD | 090314 | AB (A-rated, therapeutically equivalent) | January 30, 2026 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Imitrex Statdose (autoinjector) NDC codes
Questions
Is there a generic for Imitrex Statdose (autoinjector)?
Yes. The generic name for Imitrex Statdose (autoinjector) is sumatriptan. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Imitrex Statdose (autoinjector)?
The active ingredient in Imitrex Statdose (autoinjector) is sumatriptan, 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.