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Last Updated: December 12, 2019

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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, Anda Repository, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Lotus Pharm Co Ltd, Marksans Pharma, 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. Eighteen 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

See drug sales revenues for paricalcitol

Recent Clinical Trials for paricalcitol

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

SponsorPhase
AbbViePhase 3
IpsenPhase 1
Washington University School of MedicinePhase 1

See all paricalcitol clinical trials

Recent Litigation for paricalcitol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Washington University v. Wisconsin Alumni Research Foun2016-03-01
AbbVie Inc. v. Aurobindo Pharma Ltd.2014-02-19
AbbVie Inc. v. Hikma Pharmaceutical Co Ltd.2013-09-13

See all paricalcitol litigation

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
Synonyms for paricalcitol
(1alpha.3beta,7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol
(1R,3R,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-octahydro-1-[(1R,2E,4S)-5-hydroxy-1,4,5-trimethyl-2-hexen-1-yl]-7a-methyl-4H-inden-4-ylidene]ethylidene]-1,3-cyclohexanediol
(1R,3R,7E)-17beta-[(2R,3E,5S)-6-hydroxy-5,6-dimethylhept-3-en-2-yl]-9,10-secoestra-5,7-diene-1,3-diol
(1R,3R)-5-(2-((1R,3aS,7aR,E)-1-((2R,5S,E)-6-hydroxy-5,6-dimethylhept-3-en-2-yl)-7a-methyloctahydro-4H-inden-4-ylidene)ethylidene)cyclohexane-1,3-diol
(1R,3R)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,1R,4S)-5-hydroxy-1,4,5-trimethyl-hex-2-enyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]cyclohexane-1,3-diol
(1R,3R)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5S)-6-hydroxy-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]cyclohexane-1,3-diol
(7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1alpha,3beta,25-triol
131918-61-1
19-Nor-1-alpha,25-dihydroxyvitamin D2
19-Nor-1,25-(OH)2D2
19-Nor-1,25-dihydroxyvitamin D2
19-Nor-1alpha,25-dihydroxyvitamin D2
19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol, (1alpha,3beta,7E,22E)-
19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol,(1alpha,3beta,7E,22E)
6702D36OG5
918P611
Ab 122358
ABT-358
AC1NQY0Z
ACT07192
AKOS005145562
AN-15155
BC680819
BCP9001050
BDBM233195
BIDD:GT0330
BPKAHTKRCLCHEA-UBFJEZKGSA-N
C08127
CAS-131918-61-1
CHEBI:7931
CHEMBL1200622
Compound 49510
Compound-49510
CS-0705
D00930
DB00910
DSSTox_CID_28566
DSSTox_GSID_48640
DSSTox_RID_82838
DTXSID4048640
GTPL2791
HSDB 7360
HY-50919
LMST04030163
LS-172812
MolPort-006-167-660
NCGC00182706-01
Paracalcin
Paricalcitol (JAN/USAN/INN)
Paricalcitol [USAN:USP:INN]
Paricalcitol [USAN]
Paricalcitol, 19-nor-(OH)2-vitD2, paracalcin
PubChem18825
SC-20905
SCHEMBL3655
Tox21_112987
UNII-6702D36OG5
W-5365
Zemplar
Zemplar (TN)
ZINC13911941
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
Hospira Inc PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 201657-002 Oct 21, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Anda Repository PARICALCITOL paricalcitol CAPSULE;ORAL 202124-003 Jun 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa PARICALCITOL paricalcitol CAPSULE;ORAL 090829-002 Sep 27, 2013 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
Mylan Labs Ltd PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 203897-003 Nov 2, 2017 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 CAPSULE;ORAL 021606-003 May 26, 2005   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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