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Last Updated: June 5, 2020

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PARICALCITOL Drug Profile


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Which patents cover Paricalcitol, and when can generic versions of Paricalcitol launch?

Paricalcitol is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Accord Hlthcare, Akorn, Amneal Pharms Co, Dr Reddys, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc. and is included in seventeen NDAs.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

US ANDA Litigation and Generic Entry Outlook for Paricalcitol

A generic version of PARICALCITOL was approved as paricalcitol by SANDOZ INC on July 27th, 2011.

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Drug patent expirations by year for PARICALCITOL
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
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

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,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
1,3-Cyclohexanediol, 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]-, (1R,3R,5Z)-
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
ACT07192
AKOS005145562
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
NCGC00182706-01
Paracalcin
Paricalcitol (JAN/USAN/INN)
Paricalcitol [USAN:USP:INN]
Paricalcitol [USAN]
Paricalcitol, 19-nor-(OH)2-vitD2, paracalcin
PubChem18825
Q155746
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 201657-001 Oct 21, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 205982-001 Oct 9, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 091108-003 Jul 27, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 203897-002 Nov 2, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 207692-001 Oct 16, 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

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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Baxter
Medtronic
Colorcon
Boehringer Ingelheim

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.