FDA Orange Book · active-ingredient family
Lidocaine; prilocaine
Lidocaine; prilocaine is approved as 3 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ORAQIX · NDA 021451
3
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, disc, gel
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIDOCAINE AND PRILOCAINE | ZYDUS LIFESCIENCES | ANDA 219120 | AB | Dec 17, 2024 | |
| LIDOCAINE AND PRILOCAINE | ALEMBIC | ANDA 213923 | AB | Apr 08, 2022 | |
| LIDOCAINE AND PRILOCAINE | PADAGIS US | ANDA 212482 | AB | Jul 27, 2021 | |
| LIDOCAINE AND PRILOCAINE | CHARTWELL RX | ANDA 213253 | — | Sep 21, 2020 | |
| LIDOCAINE AND PRILOCAINE | PAI HOLDINGS PHARM | ANDA 205887 | — | Jun 29, 2018 | |
| LIDOCAINE AND PRILOCAINE | HIKMA | ANDA 076290 | — | Sep 25, 2003 | |
| LIDOCAINE AND PRILOCAINE | ENCUBE | ANDA 076320 | AB | Aug 27, 2003 | |
| LIDOCAINE AND PRILOCAINE | FOUGERA PHARMS | ANDA 076453 | AB | Aug 18, 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.
Lidocaine; prilocaine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
