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.
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 | 020862-002 | 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 |
Sanofi | HECTOROL | doxercalciferol | CAPSULE;ORAL | 020862-001 | Jun 9, 1999 | ⤷ 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 |
---|---|---|---|
Australia | 5384096 | ⤷ Try a Trial | |
Canada | 2069084 | DERIVE 1.ALPHA.-HYDROXY DE LA VITAMINE D4 ET NOUVEAUX INTERMEDIAIRES ET ANALOGUES DE CE COMPOSE (1.ALPHA.-HYDROXY VITAMIN D4 AND NOVEL INTERMEDIATES AND ANALOGUES) | ⤷ Try a Trial |
Poland | 323798 | ⤷ Try a Trial | |
Australia | 650286 | ⤷ Try a Trial | |
South Korea | 20040015301 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |