CALCITRIOL - Generic Drug Details
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What are the generic drug sources for calcitriol and what is the scope of freedom to operate?
Calcitriol
is the generic ingredient in four branded drugs marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Ss Pharma, Abbvie, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Galderma Labs Lp, Anda Repository, and Rising, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for calcitriol. Twenty-four suppliers are listed for this compound.
Summary for CALCITRIOL
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 20 |
NDAs: | 22 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 173 |
Patent Applications: | 6,144 |
Drug Prices: | Drug price trends for CALCITRIOL |
Drug Sales Revenues: | Drug sales revenues for CALCITRIOL |
What excipients (inactive ingredients) are in CALCITRIOL? | CALCITRIOL excipients list |
DailyMed Link: | CALCITRIOL at DailyMed |
Recent Clinical Trials for CALCITRIOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Phase 4 |
Chugai Pharma China Co., Ltd. | Phase 4 |
Xiaoyan Jia | Phase 4 |
Pharmacology for CALCITRIOL
Drug Class | Vitamin D3 Analog |
Medical Subject Heading (MeSH) Categories for CALCITRIOL
Anatomical Therapeutic Chemical (ATC) Classes for CALCITRIOL
US Patents and Regulatory Information for CALCITRIOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | CALCITRIOL | calcitriol | CAPSULE;ORAL | 075765-001 | Oct 12, 2001 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | CALCITRIOL | calcitriol | CAPSULE;ORAL | 204556-002 | Feb 21, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | CALCITRIOL | calcitriol | CAPSULE;ORAL | 091356-001 | Dec 12, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | CALCITRIOL | calcitriol | CAPSULE;ORAL | 204556-001 | Feb 21, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms | CALCITRIOL | calcitriol | CAPSULE;ORAL | 203289-001 | Jun 14, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | CALCITRIOL | calcitriol | INJECTABLE;INJECTION | 075836-002 | Dec 31, 2002 | DISCN | 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 |
Expired US Patents for CALCITRIOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | CALCIJEX | calcitriol | INJECTABLE;INJECTION | 018874-002 | Sep 25, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | CALCIJEX | calcitriol | INJECTABLE;INJECTION | 018874-001 | Sep 25, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | CALCIJEX | calcitriol | INJECTABLE;INJECTION | 018874-001 | Sep 25, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Ss Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ss Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ss Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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