FDA Orange Book
Generic for Imitrex
Imitrex 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 is sumatriptan. 21 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 7 Imitrex products the Orange Book lists.
Run it in Rivvi
Map Imitrex 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.
Imitrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | Discontinued | None | 11 | AP, AB |
| spray, nasal | 10MG/SPRAY | Discontinued | None | 0 | None |
| spray, nasal | 20MG/SPRAY | Marketed (Rx) | AB | 4 | AB |
| spray, nasal | 5MG/SPRAY | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | AB | 8 | AB |
NDA 020080, 020626, 020132, 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) |
| AUROBINDO PHARMA LTD | 078327 | AB (A-rated, therapeutically equivalent) | August 10, 2009 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| DR REDDYS LABORATORIES INC | 076847 | AB (A-rated, therapeutically equivalent) | August 10, 2009 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| MYLAN PHARMACEUTICALS INC | 077744 | AB (A-rated, therapeutically equivalent) | August 10, 2009 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078284 | AB (A-rated, therapeutically equivalent) | August 10, 2009 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| WATSON LABORATORIES INC | 076933 | AB (A-rated, therapeutically equivalent) | August 10, 2009 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090358 | AB (A-rated, therapeutically equivalent) | June 21, 2011 | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
| ZHEJIANG BAYSIDE BIOTECH CO LTD | 200263 | AB (A-rated, therapeutically equivalent) | June 19, 2012 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| 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) |
| LANNETT CO INC | 204841 | AB (A-rated, therapeutically equivalent) | February 19, 2016 | 20MG/SPRAY, 5MG/SPRAY |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 213465 | AB (A-rated, therapeutically equivalent) | September 21, 2020 | 20MG/SPRAY, 5MG/SPRAY |
| REGCON HOLDINGS LLC | 208967 | AB (A-rated, therapeutically equivalent) | February 17, 2021 | 20MG/SPRAY |
| CIPLA LTD | 214209 | AB (A-rated, therapeutically equivalent) | February 22, 2021 | 20MG/SPRAY |
| 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) |
| VKT PHARMA PRIVATE LTD | 219036 | AB (A-rated, therapeutically equivalent) | December 31, 2024 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| IPCA LABORATORIES LTD | 206019 | AB (A-rated, therapeutically equivalent) | July 15, 2025 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 213518 | AB (A-rated, therapeutically equivalent) | November 6, 2025 | 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 NDC codes
Questions
Is there a generic for Imitrex?
Yes. The generic name for Imitrex is sumatriptan. 21 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 7 Imitrex products the Orange Book lists.
What is the generic name for Imitrex?
The active ingredient in Imitrex 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.
More on Imitrex and Sumatriptan
- What is Sumatriptan used for?FDA label uses
- Is Sumatriptan a controlled substance?Federal schedule
- Generic for Alsuma (autoinjector)FDA Orange Book
- Generic for Imitrex Statdose (autoinjector)FDA Orange Book
- Generic for Sumavel DoseproFDA Orange Book
- Generic for Zembrace Symtouch (autoinjector)FDA Orange Book
- Generic for TosymraFDA Orange Book
- Serotonin-1b and Serotonin-1d Receptor Agonists listFDA drug class
- NDC 0173-0478Imitrex NDC record
- NDC 0173-0479Imitrex NDC record
- NDC 0173-0735Imitrex NDC record