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Paricalcitol - Generic Drug Details

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Paricalcitol is the generic ingredient in two branded drugs marketed by Abbvie, Sandoz Canada 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, and Accord Hlthcare, and is included in fifteen NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient 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:3
Applicants:13
NDAs:15
Drug Master File Entries: see list10
Suppliers / Packaging: see list18
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: paricalcitol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION2MCG/ML
<disabled><disabled>INJECTABLE; INJECTION5MCG/ML
<disabled><disabled>INJECTABLE; INJECTION10MCG/ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
ZEMPLAR
paricalcitol
SOLUTION;INTRAVENOUS020819-002Feb 1, 2000RXYes6,136,799*PED► subscribeY► subscribe
Rising Pharms Inc
PARICALCITOL
paricalcitol
CAPSULE;ORAL202124-002Jun 24, 2014RXNo► subscribe► subscribe
Rising Pharms Inc
PARICALCITOL
paricalcitol
CAPSULE;ORAL202124-001Jun 24, 2014RXNo► 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
CAPSULE;ORAL021606-003May 26, 20055,587,497*PED► subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-003May 26, 20055,597,815*PED► subscribe
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-001May 26, 20055,246,925*PED► subscribe
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International Patent Family for Ingredient: paricalcitol

Country Document Number Estimated Expiration
Japan2014129360► subscribe
Japan2002510652► subscribe
Japan4664499► 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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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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