FDA Orange Book · active-ingredient family
Zolmitriptan
Zolmitriptan is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZOMIG · NDA 021450
3
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · spray, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZOMIGRLD×2 | AMNEAL | NDA 021450 | AB | Sep 16, 2013 | |
| ZOMIG-ZMTRLD×2 | ASTRAZENECA | NDA 021231 | — | Feb 13, 2001 | |
| ZOMIGRLD×2 | IPR | NDA 020768 | — | Nov 25, 1997 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZOLMITRIPTAN×2 | PADAGIS ISRAEL | ANDA 212469 | AB | Sep 30, 2021 | |
| ZOLMITRIPTAN×2 | ORBION PHARMS | ANDA 203726 | AB | Oct 21, 2019 | |
| ZOLMITRIPTAN×2 | RISING | ANDA 202855 | — | Sep 20, 2019 | |
| ZOLMITRIPTAN×2 | ZYDUS PHARMS | ANDA 203019 | AB | Jul 11, 2018 | |
| ZOLMITRIPTAN×2 | CHARTWELL RX | ANDA 206973 | AB | Jun 30, 2017 | |
| ZOLMITRIPTAN×2 | PLD ACQUISITIONS LLC | ANDA 207867 | AB | Feb 27, 2017 | |
| ZOLMITRIPTAN×2 | ALEMBIC | ANDA 205074 | AB | Dec 01, 2016 | |
| ZOLMITRIPTAN×2 | AJANTA PHARMA LTD | ANDA 204041 | AB | May 20, 2016 | |
| ZOLMITRIPTAN×2 | AUROBINDO PHARMA | ANDA 207021 | AB | May 11, 2016 | |
| ZOLMITRIPTAN×2 | MACLEODS PHARMS LTD | ANDA 204336 | — | Oct 22, 2015 | |
| ZOLMITRIPTAN×2 | ALEMBIC | ANDA 204232 | AB | Sep 30, 2015 | |
| ZOLMITRIPTAN×2 | MACLEODS PHARMS LTD | ANDA 203772 | — | Sep 30, 2015 | |
| ZOLMITRIPTAN×2 | JUBILANT GENERICS | ANDA 202956 | AB | Sep 17, 2015 | |
| ZOLMITRIPTAN×2 | JUBILANT GENERICS | ANDA 202279 | AB | Nov 20, 2014 | |
| ZOLMITRIPTAN×2 | SUN PHARMA GLOBAL | ANDA 203476 | — | Nov 13, 2014 | |
| ZOLMITRIPTAN×2 | INVAGEN PHARMS | ANDA 204284 | — | Apr 09, 2014 | |
| ZOLMITRIPTAN×2 | ANI PHARMS | ANDA 090861 | — | Mar 04, 2014 | |
| ZOLMITRIPTAN×2 | ZYDUS PHARMS USA INC | ANDA 202890 | AB | May 15, 2013 | |
| ZOLMITRIPTAN×2 | APOTEX INC | ANDA 202476 | — | May 14, 2013 | |
| ZOLMITRIPTAN×2 | GLENMARK PHARMS LTD | ANDA 202560 | AB | May 14, 2013 | |
| ZOLMITRIPTAN×2 | APOTEX INC | ANDA 202078 | — | May 14, 2013 | |
| ZOLMITRIPTAN×2 | GLENMARK PHARMS LTD | ANDA 201779 | AB | May 14, 2013 | |
| ZOLMITRIPTAN×2 | NATCO PHARMA USA | ANDA 203186 | — | May 14, 2013 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Zolmitriptan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
