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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, Lotus Pharm Co Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Rising Pharms Inc, Amneal Pharms, Teva Pharms Usa, Bionpharma Inc, Hospira Inc, Aurobindo Pharma Ltd, and Accord Hlthcare, and is included in thirteen 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. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: paricalcitol

Tradenames:2
Patents:3
Applicants:12
NDAs:13
Drug Master File Entries: see list10
Suppliers / Packaging: see list15
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

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

Clinical Trials for: paricalcitol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms
PARICALCITOL
paricalcitol
SOLUTION;INTRAVENOUS205917-003Nov 18, 2014RXNo<disabled><disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-002May 26, 2005RXNo5,597,815*PED<disabled>Y<disabled>
Rising Pharms Inc
PARICALCITOL
paricalcitol
CAPSULE;ORAL202124-002Jun 24, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: paricalcitol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
ZEMPLAR
paricalcitol
SOLUTION;INTRAVENOUS020819-001Apr 17, 19985,587,497*PED<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-002May 26, 20055,246,925*PED<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-001May 26, 20055,246,925*PED<disabled>
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International Patent Family for Ingredient: paricalcitol

Country Document Number Estimated Expiration
Japan2016053046<disabled in preview>
Australia3359899<disabled in preview>
World Intellectual Property Organization (WIPO)9951271<disabled in preview>
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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<disabled>PRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721
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