DIGOXIN - Generic Drug Details
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What are the generic sources for digoxin and what is the scope of freedom to operate?
Digoxin
is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Amici, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Covis, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, Sun Pharm Inds Inc, and Concordia, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for digoxin. Twenty-nine suppliers are listed for this compound.
Summary for DIGOXIN
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 17 |
NDAs: | 20 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 233 |
Patent Applications: | 6,645 |
Drug Prices: | Drug price trends for DIGOXIN |
Drug Sales Revenues: | Drug sales revenues for DIGOXIN |
What excipients (inactive ingredients) are in DIGOXIN? | DIGOXIN excipients list |
DailyMed Link: | DIGOXIN at DailyMed |
Recent Clinical Trials for DIGOXIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
Jacobio Pharmaceuticals Co., Ltd. | Phase 1 |
Loxo Oncology, Inc. | Phase 1 |
Pharmacology for DIGOXIN
Drug Class | Cardiac Glycoside |
Medical Subject Heading (MeSH) Categories for DIGOXIN
Anatomical Therapeutic Chemical (ATC) Classes for DIGOXIN
US Patents and Regulatory Information for DIGOXIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Concordia | LANOXIN | digoxin | TABLET;ORAL | 020405-005 | Sep 30, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novitium Pharma | DIGOXIN | digoxin | TABLET;ORAL | 215307-003 | Aug 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wyeth Ayerst | DIGOXIN | digoxin | INJECTABLE;INJECTION | 084386-001 | Approved Prior to Jan 1, 1982 | 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 DIGOXIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-001 | Jul 26, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-002 | Jul 26, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-004 | Sep 24, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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