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Last Updated: March 28, 2024

Paricalcitol - Generic Drug Details


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What are the generic sources for paricalcitol and what is the scope of patent protection?

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
Cedars-Sinai Medical CenterEarly Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early 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 Trial5MCG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial2MCG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial10MCG/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
Accord Hlthcare PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207174-003 Feb 4, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-002 May 26, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 091108-003 Jul 27, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207174-001 Feb 4, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising PARICALCITOL paricalcitol CAPSULE;ORAL 202124-002 Jun 24, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa PARICALCITOL paricalcitol CAPSULE;ORAL 090829-002 Sep 27, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 203897-002 Nov 2, 2017 AP 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
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.