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Last Updated: March 29, 2024

PARICALCITOL - Generic Drug Details


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What are the generic sources for paricalcitol and what is the scope of freedom to operate?

Paricalcitol is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Abbvie, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for paricalcitol. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for PARICALCITOL

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Drug Sales Revenue Trends for PARICALCITOL

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Recent Clinical Trials for PARICALCITOL

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SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early Phase 1
Cedars-Sinai Medical CenterEarly Phase 1
Chengdu Suncadia Medicine Co., Ltd.Phase 3

See all PARICALCITOL clinical trials

Generic filers with tentative approvals for PARICALCITOL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10MCG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial5MCG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial2MCG/MLINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PARICALCITOL
Paragraph IV (Patent) Challenges for PARICALCITOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZEMPLAR Injection paricalcitol 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials 020819 1 2008-11-28
ZEMPLAR Capsules paricalcitol 1 mcg and 2 mcg 021606 1 2008-10-14
ZEMPLAR Capsules paricalcitol 4 mcg 021606 1 2008-08-25

US Patents and Regulatory Information for PARICALCITOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lotus Pharm Co Ltd PARICALCITOL paricalcitol CAPSULE;ORAL 206710-002 Feb 24, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 206699-003 Mar 9, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising PARICALCITOL paricalcitol CAPSULE;ORAL 202124-001 Jun 24, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys PARICALCITOL paricalcitol CAPSULE;ORAL 091412-002 Jun 24, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PARICALCITOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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