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Generated: October 21, 2018

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PARICALCITOL - Generic Drug Details

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What are the generic sources for paricalcitol and what is the scope of paricalcitol 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 Pharms, Teva Pharms Usa, Abbvie, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in nineteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for paricalcitol. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for PARICALCITOL
Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog
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
Abbott brand of paricalcitol
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
D0N1TP
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
OR009715
OR213437
Paracalcin
Paricalcitol (JAN/USAN/INN)
Paricalcitol (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
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

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
Amneal Pharms PARICALCITOL paricalcitol CAPSULE;ORAL 204327-003 Jan 13, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 204910-002 Aug 17, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms PARICALCITOL paricalcitol CAPSULE;ORAL 204327-002 Jan 13, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-002 Feb 1, 2000 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 AB RX Yes 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

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Expired US Patents for PARICALCITOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021606-003 May 26, 2005 ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol SOLUTION;INTRAVENOUS 020819-001 Apr 17, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for PARICALCITOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/003 United Kingdom ➤ Sign Up PRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Colorcon
Express Scripts
Moodys
Deloitte
McKesson
Merck
Johnson and Johnson

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