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Last Updated: November 21, 2024

Paricalcitol - Generic Drug Details


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What are the generic drug 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. Twelve 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
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
⤷  Sign Up⤷  Sign Up10MCG/MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up5MCG/MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up2MCG/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
Dr Reddys PARICALCITOL paricalcitol CAPSULE;ORAL 091412-001 Jun 24, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Pharms PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917-003 Nov 18, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Pharms PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205917-002 Nov 18, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma PARICALCITOL paricalcitol CAPSULE;ORAL 202539-003 Mar 27, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 ⤷  Sign Up ⤷  Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 ⤷  Sign Up ⤷  Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 ⤷  Sign Up ⤷  Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-003 Feb 1, 2000 ⤷  Sign Up ⤷  Sign Up
>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.