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Doxercalciferol - Generic Drug Details

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Doxercalciferol is the generic ingredient in two branded drugs marketed by Hikma Pharms Llc, Sandoz Inc, Genzyme Corp, Akorn Inc, and Roxane, and is included in seven NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has eight patent family members in six countries.

There are nine drug master file entries for doxercalciferol. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: doxercalciferol

Tradenames:2
Patents:1
Applicants:5
NDAs:7
Drug Master File Entries: see list9
Suppliers / Packaging: see list7
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: doxercalciferol

Ingredient-typeErgocalciferols
Drug ClassVitamin D2 Analog

Tentative approvals for DOXERCALCIFEROL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION2MCG/ML

Clinical Trials for: doxercalciferol

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;INJECTION021027-001Apr 6, 2000RXYes<disabled><disabled>
Genzyme Corp
HECTOROL
doxercalciferol
CAPSULE;ORAL020862-002Apr 23, 2004RXNo6,903,083<disabled>YYY <disabled>
Akorn Inc
DOXERCALCIFEROL
doxercalciferol
INJECTABLE;INJECTION203929-001May 7, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: doxercalciferol

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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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International Patent Family for Ingredient: doxercalciferol

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