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HECTOROL Drug Profile

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Hectorol is a drug marketed by Genzyme Corp and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug and four Paragraph IV challenges.

This drug has eight patent family members in six countries.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the doxercalciferol profile page.

Summary for Tradename: HECTOROL

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

Pharmacology for Tradename: HECTOROL

Ingredient-typeErgocalciferols
Drug ClassVitamin D2 Analog

Clinical Trials for: HECTOROL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
HECTOROL
doxercalciferol
INJECTABLE;INJECTION021027-002Apr 6, 2000RXNo<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-003Jul 13, 2009RXNo<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
INJECTABLE;INJECTION021027-001Apr 6, 2000RXYes<disabled><disabled>
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Expired Patents for Tradename: HECTOROL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-002Apr 23, 20045,869,473<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-001Jun 9, 19995,602,116<disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-001Jun 9, 19995,861,386<disabled>
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Paragraph IV activity for: HECTOROL

Drugname Dosage Strength RLD Submissiondate
doxercalciferolInjection2 mcg/mL, 1 mL in 2 mL vialHectorol12/28/2011
doxercalciferolCapsules1 mcgHectorol2/12/2010
doxercalciferolCapsules0.5 mcg and 2.5 mcgHectorol3/25/2009
doxercalciferolInjection2 mcg/mL, 2 mL ampulesHectorol10/15/2007

International Patent Family for Tradename: HECTOROL

Country Document Number Estimated Expiration
Australia2001278956<disabled in preview>
Israel153378<disabled in preview>
European Patent Office2070911<disabled in preview>
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