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Last Updated: November 27, 2022

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, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Abbvie, Accord Hlthcare, Akorn, Amneal Pharms Co, Eugia Pharma, Hikma Pharms, Hospira, 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. Fourteen 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chengdu Suncadia Medicine Co., Ltd.Phase 3
Cancer Trials IrelandPhase 2
AbbViePhase 3

See all paricalcitol clinical trials

Generic filers with tentative approvals for PARICALCITOL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MCG/MLINJECTABLE; INJECTION
See Plans and PricingSee Plans and Pricing5MCG/MLINJECTABLE; INJECTION
See Plans and PricingSee Plans and Pricing2MCG/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
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bionpharma Inc PARICALCITOL paricalcitol CAPSULE;ORAL 202539-001 Mar 27, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 204910-001 Aug 17, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 201657-001 Oct 21, 2014 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bionpharma Inc PARICALCITOL paricalcitol CAPSULE;ORAL 202539-003 Mar 27, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Marksans Pharma PARICALCITOL paricalcitol CAPSULE;ORAL 204948-001 Oct 7, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 See Plans and Pricing See Plans and Pricing
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-002 May 26, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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