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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Citi
US Department of Justice
Teva
Cerilliant
Moodys
Daiichi Sankyo
Covington
Express Scripts
Cipla

Generated: August 19, 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 Abbvie, Sandoz Inc, Eci Pharms Llc, Dr Reddys Labs Ltd, Hikma Pharms, Rising Pharms Inc, Amneal Pharms, Teva Pharms Usa, Bionpharma Inc, Marksans Pharma, Hospira Inc, Aurobindo Pharma Ltd, Accord Hlthcare, and Amneal Pharms Co, and is included in sixteen 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 fifteen patent family members in ten countries.

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

Summary for Generic Name: paricalcitol

Tradenames:2
Patents:2
Applicants:14
NDAs:16
Drug Master File Entries: see list10
Suppliers / Packagers: see list18
Bulk Api Vendors: see list39
Clinical Trials: see list77
Patent Applications: see list1,131
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paricalcitol at DailyMed

Pharmacology for Ingredient: paricalcitol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2MCG/MLINJECTABLE; INJECTION
► Subscribe► Subscribe10MCG/MLINJECTABLE; INJECTION
► Subscribe► Subscribe5MCG/MLINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
PARICALCITOL
paricalcitol
SOLUTION;INTRAVENOUS207174-001Feb 4, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Co
PARICALCITOL
paricalcitol
SOLUTION;INTRAVENOUS206699-001Mar 9, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Marksans Pharma
PARICALCITOL
paricalcitol
CAPSULE;ORAL204948-001Oct 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Co
PARICALCITOL
paricalcitol
SOLUTION;INTRAVENOUS206699-003Mar 9, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
PARICALCITOL
paricalcitol
CAPSULE;ORAL207672-003Jan 14, 2016ABRXNoNo► 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
Abbvie
ZEMPLAR
paricalcitol
SOLUTION;INTRAVENOUS020819-001Apr 17, 1998► Subscribe► Subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-001May 26, 2005► Subscribe► Subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: paricalcitol

Country Document Number Estimated Expiration
Germany69920201► Subscribe
Japan2002510652► Subscribe
Japan2016053046► Subscribe
Denmark1073467► 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 database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Colorcon
Moodys
US Army
McKesson
Medtronic
Chubb
Fuji
QuintilesIMS
Cantor Fitzgerald

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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