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. Nine 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for HECTOROL?
- What are the global sales for HECTOROL?
- What is Average Wholesale Price for HECTOROL?
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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-002 | Apr 6, 2000 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi | HECTOROL | doxercalciferol | CAPSULE;ORAL | 020862-003 | Jul 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi | HECTOROL | doxercalciferol | CAPSULE;ORAL | 020862-001 | Jun 9, 1999 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-001 | Apr 6, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | CAPSULE;ORAL | 020862-002 | Apr 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-002 | Apr 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-001 | Apr 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-001 | Apr 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | HECTOROL | doxercalciferol | CAPSULE;ORAL | 020862-001 | Jun 9, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi | HECTOROL | doxercalciferol | INJECTABLE;INJECTION | 021027-001 | Apr 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Canada | 1341408 | METHODE DE PREVENTION ET DE TRAITEMENT DE LA PERTE DE MASSE OSSEUSE (METHOD FOR TREATING AND PREVENTING LOSS OF BONE MASS) | ⤷ Sign Up |
Hungary | 9201691 | ⤷ Sign Up | |
Brazil | 9713663 | ⤷ Sign Up | |
Spain | 2169023 | ⤷ Sign Up | |
New Zealand | 336508 | ⤷ Sign Up | |
Australia | 3656193 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |