DOXERCALCIFEROL Drug Patent Profile
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Which patents cover Doxercalciferol, and what generic alternatives are available?
Doxercalciferol is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm. and is included in sixteen NDAs.
The generic ingredient in DOXERCALCIFEROL 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 Doxercalciferol
A generic version of DOXERCALCIFEROL was approved as doxercalciferol by HIKMA on August 30th, 2013.
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Questions you can ask:
- What is the 5 year forecast for DOXERCALCIFEROL?
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- What is Average Wholesale Price for DOXERCALCIFEROL?
Summary for DOXERCALCIFEROL
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 18 |
| Patent Applications: | 1,398 |
| Drug Prices: | Drug price information for DOXERCALCIFEROL |
| What excipients (inactive ingredients) are in DOXERCALCIFEROL? | DOXERCALCIFEROL excipients list |
| DailyMed Link: | DOXERCALCIFEROL at DailyMed |
Recent Clinical Trials for DOXERCALCIFEROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sanofi | Phase 3 |
| OPKO Health, Inc. | Phase 3 |
| OPKO Ireland Global Holdings Ltd. | Phase 3 |
Pharmacology for DOXERCALCIFEROL
| Drug Class | Vitamin D2 Analog |
Anatomical Therapeutic Chemical (ATC) Classes for DOXERCALCIFEROL
Paragraph IV (Patent) Challenges for DOXERCALCIFEROL
| 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 DOXERCALCIFEROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avet | DOXERCALCIFEROL | doxercalciferol | CAPSULE;ORAL | 205360-001 | Sep 15, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 210452-001 | Sep 26, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 091333-001 | May 5, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | DOXERCALCIFEROL | doxercalciferol | CAPSULE;ORAL | 201518-001 | Sep 9, 2016 | AB | RX | No | No | ⤷ 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 |
