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Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Paricalcitol - Generic Drug Details

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What are the generic drug 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 Inc, Dr Reddys Labs Ltd, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Abbvie, Accord Hlthcare, Akorn, Amneal Pharms Co, Dr Reddys, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, 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. Seventeen 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
Cancer Trials IrelandPhase 2
Emory UniversityPhase 2
AbbViePhase 3

See all paricalcitol clinical trials

Generic filers with tentative approvals for PARICALCITOL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MCG/MLINJECTABLE; INJECTION
  Start Trial  Start Trial5MCG/MLINJECTABLE; INJECTION
  Start Trial  Start 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 NDA Submissiondate
ZEMPLAR SOLUTION;INTRAVENOUS paricalcitol 020819 2008-11-28
ZEMPLAR CAPSULE;ORAL paricalcitol 021606 2008-10-14
ZEMPLAR CAPSULE;ORAL paricalcitol 021606 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
Dr Reddys PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 204910-001 Aug 17, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 206699-002 Mar 9, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207174-002 Feb 4, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd PARICALCITOL paricalcitol CAPSULE;ORAL 091412-002 Jun 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PARICALCITOL paricalcitol CAPSULE;ORAL 207672-003 Jan 14, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PARICALCITOL paricalcitol CAPSULE;ORAL 207672-002 Jan 14, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 204910-003 Aug 17, 2016 AP RX No No   Start Trial   Start Trial   Start 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 020819-003 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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