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ZEMPLAR Drug Profile

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Zemplar is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug and three Paragraph IV challenges.

This drug has fifteen patent family members in ten countries.

The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the paricalcitol profile page.

Summary for Tradename: ZEMPLAR

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list2

Pharmacology for Tradename: ZEMPLAR

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Clinical Trials for: ZEMPLAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-001May 26, 2005RXNo5,597,815*PED<disabled>Y<disabled>
Abbvie
ZEMPLAR
paricalcitol
SOLUTION;INTRAVENOUS020819-001Apr 17, 1998RXYes6,361,758*PED<disabled>Y<disabled>
Abbvie
ZEMPLAR
paricalcitol
SOLUTION;INTRAVENOUS020819-002Feb 1, 2000RXYes6,361,758*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ZEMPLAR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-003May 26, 20055,587,497*PED<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-003May 26, 20055,597,815*PED<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606-001May 26, 20055,246,925*PED<disabled>
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Paragraph IV activity for: ZEMPLAR

Drugname Dosage Strength RLD Submissiondate
paricalcitolInjection0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vialsZemplar11/28/2008
paricalcitolCapsules1 mcg and 2 mcgZemplar10/14/2008
paricalcitolCapsules4 mcgZemplar8/25/2008

International Patent Family for Tradename: ZEMPLAR

Country Document Number Estimated Expiration
Canada2326198<disabled in preview>
Japan2002510652<disabled in preview>
Japan2014129360<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: ZEMPLAR

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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