FDA Orange Book · active-ingredient family
Paricalcitol
Paricalcitol is approved as 5 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZEMPLAR · NDA 021606
5
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEMPLARRLD×3 | ABBVIE | NDA 021606 | — | May 26, 2005 | |
| ZEMPLARRLD×3 | ABBVIE | NDA 020819 | AP | Feb 01, 2000 | |
| PARICALCITOL×3 | ACCORD HLTHCARE | NDA 207174 | AP | Feb 04, 2016 | |
| PARICALCITOL×3 | HIKMA PHARMS | NDA 205917 | — | Nov 18, 2014 | |
| PARICALCITOL×3 | HOSPIRA | NDA 201657 | — | Oct 21, 2014 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PARICALCITOL×3 | EUGIA PHARMA | ANDA 205982 | — | Oct 09, 2018 | |
| PARICALCITOL×3 | RISING | ANDA 203897 | — | Nov 02, 2017 | |
| PARICALCITOL | EPIC PHARMA LLC | ANDA 207692 | — | Oct 16, 2017 | |
| PARICALCITOL×3 | AMNEAL PHARMS CO | ANDA 206699 | AP | Mar 09, 2017 | |
| PARICALCITOL×3 | MARKSANS PHARMA | ANDA 204948 | AB | Oct 07, 2016 | |
| PARICALCITOL×3 | CAPLIN | ANDA 204910 | — | Aug 17, 2016 | |
| PARICALCITOL×3 | LOTUS PHARM CO LTD | ANDA 206710 | — | Feb 24, 2016 | |
| PARICALCITOL×3 | AUROBINDO PHARMA LTD | ANDA 207672 | AB | Jan 14, 2016 | |
| PARICALCITOL×3 | AMNEAL PHARMS | ANDA 204327 | AB | Jan 13, 2016 | |
| PARICALCITOL×3 | CHARTWELL RX | ANDA 091412 | AB | Jun 24, 2014 | |
| PARICALCITOL×3 | RISING | ANDA 202124 | AB | Jun 24, 2014 | |
| PARICALCITOL×3 | BIONPHARMA | ANDA 202539 | AB | Mar 27, 2014 | |
| PARICALCITOL×3 | TEVA PHARMS USA | ANDA 090829 | AB | Sep 27, 2013 | |
| PARICALCITOL×3 | SANDOZ | ANDA 091108 | AP | Jul 27, 2011 |
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.
Paricalcitol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
