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Last Updated: March 28, 2024

HECTOROL Drug Patent Profile


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Which patents cover Hectorol, and when can generic versions of Hectorol launch?

Hectorol is a drug marketed by Sanofi and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Hectorol

A generic version of HECTOROL was approved as doxercalciferol by HIKMA on August 30th, 2013.

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Drug patent expirations by year for HECTOROL
Drug Prices for HECTOROL

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Drug Sales Revenue Trends for HECTOROL

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Recent Clinical Trials for HECTOROL

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SponsorPhase
SanofiPhase 3
Mariana MarkellPhase 4
OPKO IP Holdings II, Inc.Phase 1

See all HECTOROL clinical trials

Pharmacology for HECTOROL
Drug ClassVitamin D2 Analog
Paragraph IV (Patent) Challenges for HECTOROL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HECTOROL Injection doxercalciferol 2 mcg/mL, 1 mL in 2 mL vial 021027 1 2011-12-28
HECTOROL Capsules doxercalciferol 1 mcg 020862 1 2010-02-12
HECTOROL Capsules doxercalciferol 0.5 mcg and 2.5 mcg 020862 1 2009-03-25
HECTOROL Injection doxercalciferol 2 mcg/mL, 2 mL ampules 021027 1 2007-10-15

US Patents and Regulatory Information for HECTOROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-002 Apr 6, 2000 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-003 Jul 13, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-001 Jun 9, 1999 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for HECTOROL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol CAPSULE;ORAL 020862-002 Apr 23, 2004 ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-002 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HECTOROL

See the table below for patents covering HECTOROL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0948334 PROCEDE DE TRAITEMENT DE MALADIES PROSTATIQUES AU MOYEN D'ANALOGUES ACTIFS DE LA VITAMINE D (METHOD OF TREATING PROSTATIC DISEASES USING ACTIVE VITAMIN D ANALOGUES) ⤷  Try a Trial
China 100349573 ⤷  Try a Trial
Brazil 9910671 ⤷  Try a Trial
European Patent Office 0381750 PROCEDE DE TRAITEMENT ET DE PREVENTION DE LA PERTE DE MASSE OSSEUSE. (METHOD FOR TREATING AND PREVENTING LOSS OF BONE MASS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.