FDA Orange Book · active-ingredient family
Mirtazapine
Mirtazapine is approved as 2 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REMERON SOLTAB · NDA 021208
2
Brand (NDA)
24
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REMERON SOLTABRLD×3 | ORGANON USA ORGANON | NDA 021208 | AB | Jan 12, 2001 | |
| REMERONRLD×3 | ORGANON | NDA 020415 | AB | Jun 14, 1996 |
Generic (ANDA) products (24)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIRTAZAPINE×4 | MICRO LABS | ANDA 220104 | AB | May 19, 2026 | |
| MIRTAZAPINE×4 | NOVITIUM PHARMA | ANDA 219919 | AB | Feb 02, 2026 | |
| MIRTAZAPINE×4 | ANNORA PHARMA | ANDA 219721 | AB | Oct 02, 2025 | |
| MIRTAZAPINE×4 | PRASCO | ANDA 216751 | AB | Jan 18, 2023 | |
| MIRTAZAPINE×3 | SQUARE PHARMS PLC | ANDA 205798 | AB | Jun 01, 2017 | |
| MIRTAZAPINE×3 | ACTAVIS ELIZABETH | ANDA 077959 | — | Feb 14, 2011 | |
| MIRTAZAPINE×3 | APOTEX | ANDA 077666 | AB | Aug 22, 2007 | |
| MIRTAZAPINE×3 | AUROBINDO PHARMA | ANDA 077376 | AB | Dec 08, 2005 | |
| MIRTAZAPINE×3 | ACTAVIS ELIZABETH | ANDA 076689 | — | Aug 31, 2005 | |
| MIRTAZAPINE×3 | IMPAX LABS INC | ANDA 076901 | — | Jun 28, 2005 | |
| MIRTAZAPINE×4 | AUROBINDO | ANDA 076921 | AB | Oct 22, 2004 | |
| MIRTAZAPINE×4 | SUN PHARM INDS INC | ANDA 076541 | AB | Apr 22, 2004 | |
| MIRTAZAPINE×3 | IVAX SUB TEVA PHARMS | ANDA 076244 | — | Dec 22, 2003 | |
| MIRTAZAPINE×3 | ACTAVIS LABS FL INC | ANDA 076307 | — | Dec 17, 2003 | |
| MIRTAZAPINE×3 | ACTAVIS ELIZABETH | ANDA 076241 | — | Jun 25, 2003 | |
| MIRTAZAPINE×3 | ACTAVIS ELIZABETH | ANDA 076308 | — | Jun 20, 2003 | |
| MIRTAZAPINE×3 | ACTAVIS LABS FL INC | ANDA 076336 | — | Jun 20, 2003 | |
| MIRTAZAPINE×3 | CHARTWELL RX | ANDA 076219 | AB | Jun 19, 2003 | |
| MIRTAZAPINE×3 | MYLAN | ANDA 076122 | AB | Jun 19, 2003 | |
| MIRTAZAPINE×3 | PHARMOBEDIENT | ANDA 076176 | — | Jun 19, 2003 | |
| MIRTAZAPINE×3 | ROXANE | ANDA 076270 | — | Jun 19, 2003 | |
| MIRTAZAPINE×3 | UPSHER SMITH LABS | ANDA 076189 | — | Jun 19, 2003 | |
| MIRTAZAPINE×3 | WATSON LABS | ANDA 076312 | — | Jun 19, 2003 | |
| MIRTAZAPINE×3 | TEVA | ANDA 076119 | AB | Jan 24, 2003 |
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.
Mirtazapine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
