HECTOROL Drug Patent Profile
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Which patents cover Hectorol, and what generic alternatives are available?
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.
Summary for HECTOROL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 11 |
Patent Applications: | 1,398 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HECTOROL |
What excipients (inactive ingredients) are in HECTOROL? | HECTOROL excipients list |
DailyMed Link: | HECTOROL at DailyMed |
Recent Clinical Trials for HECTOROL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 3 |
Mariana Markell | Phase 4 |
OPKO IP Holdings II, Inc. | Phase 1 |
Pharmacology for HECTOROL
Drug Class | Vitamin D2 Analog |
Anatomical Therapeutic Chemical (ATC) Classes for HECTOROL
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 | |||
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-001 | Apr 6, 2000 | AP | 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 | 020862-001 | Jun 9, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
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 | 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 | CAPSULE;ORAL | 020862-003 | Jul 13, 2009 | ⤷ 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 | 0820290 | UTILISATION DE DERIVES DE LA VITAMINE D 2 OU D 4 POUR FABRIQUER UN MEDICAMENT DESTINE AU TRAITEMENT DE L'HYPERPARATHYROIDISME SECONDAIRE (USE OF VITAMIN D 2 OR VITAMIN D 4-DERIVATIVES FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM) | ⤷ Try a Trial |
Mexico | 9707535 | USO DE DERIVADOS DE VITAMINA D2 O DE VITAMINA D4 EN LA PREPARACION DE UN FARMACO PARA EL TRATAMIENTO DE HIPERPARATIROIDISMO SECUNDARIO. (USE OF VITAMIN D2 OR VITAMIN D4-DERIVATIVES FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM.) | ⤷ Try a Trial |
China | 1520301 | ⤷ Try a Trial | |
Austria | 250566 | ⤷ Try a Trial | |
Canada | 2222593 | ⤷ Try a Trial | |
European Patent Office | 0631500 | 1 alpha-HYDROXY-24-(EPI)-VITAMINE D4 (1 alpha-HYDROXY-24-(EPI)-VITAMIN D4) | ⤷ Try a Trial |
Israel | 139355 | 24-HYDROXYVITAMIN D, ANALOGS AND USES THEREOF | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |