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Serving leading biopharmaceutical companies globally:

McKesson
Citi
Chinese Patent Office
Deloitte
Novartis
McKinsey
Cipla
US Department of Justice
Accenture
Teva

Generated: December 12, 2017

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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 paricalcitol patent protection?

Paricalcitol
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma Inc, Dr Reddys Labs Ltd, Eci Pharms Llc, Marksans Pharma, Rising Pharms Inc, Teva Pharms Usa, Abbvie, Accord Hlthcare, Akorn, Amneal Pharms Co, Hikma Pharms, Hospira Inc, Mylan Labs Ltd, and Sandoz Inc, and is included in eighteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Paricalcitol has seventeen patent family members in ten countries and one supplementary protection certificate in one country.

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

Pharmacology for paricalcitol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

Applicant Application No. Strength Dosage Form
u► Subscribe2MCG/MLINJECTABLE; INJECTION
u► Subscribe10MCG/MLINJECTABLE; INJECTION
u► Subscribe5MCG/MLINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Labs LtdPARICALCITOLparicalcitolSOLUTION;INTRAVENOUS203897-002Nov 2, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdPARICALCITOLparicalcitolCAPSULE;ORAL207672-003Jan 14, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaPARICALCITOLparicalcitolCAPSULE;ORAL090829-002Sep 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hikma PharmsPARICALCITOLparicalcitolSOLUTION;INTRAVENOUS205917-003Nov 18, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sandoz IncPARICALCITOLparicalcitolSOLUTION;INTRAVENOUS091108-003Jul 27, 2011APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Accord HlthcarePARICALCITOLparicalcitolSOLUTION;INTRAVENOUS207174-001Feb 4, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsPARICALCITOLparicalcitolCAPSULE;ORAL204327-002Jan 13, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hikma PharmsPARICALCITOLparicalcitolSOLUTION;INTRAVENOUS205917-001Nov 18, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Hospira IncPARICALCITOLparicalcitolSOLUTION;INTRAVENOUS201657-002Oct 21, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paricalcitol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolSOLUTION;INTRAVENOUS020819-001Apr 17, 1998► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolSOLUTION;INTRAVENOUS020819-001Apr 17, 1998► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolSOLUTION;INTRAVENOUS020819-001Apr 17, 1998► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-001May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolSOLUTION;INTRAVENOUS020819-002Feb 1, 2000► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolSOLUTION;INTRAVENOUS020819-002Feb 1, 2000► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: paricalcitol

Country Document Number Estimated Expiration
Japan2011037860► Subscribe
Portugal1073467► Subscribe
Japan2002510652► Subscribe
Japan2016053046► Subscribe
Denmark1073467► Subscribe
Canada2326198► Subscribe
World Intellectual Property Organization (WIPO)9951271► Subscribe
Germany69920201► Subscribe
Australia758989► Subscribe
Japan5887368► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PARICALCITOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/003United Kingdom► SubscribePRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Chinese Patent Office
Deloitte
Medtronic
Argus Health
US Department of Justice
Moodys
Harvard Business School
Covington
Express Scripts

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 verifification 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.

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