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Digoxin - Generic Drug Details
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, Hikma, Vistapharm, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Covis, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, Sun Pharm Inds Inc, and Concordia, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for digoxin. Twenty-five suppliers are listed for this compound.
Summary for digoxin
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 15 |
| NDAs: | 17 |
| Drug Master File Entries: | 10 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 186 |
| Patent Applications: | 7,001 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Tanta University | Phase 2 |
| Mirati Therapeutics Inc. | Phase 1 |
| I.M. Sechenov First Moscow State Medical University | Phase 4 |
Pharmacology for digoxin
| Drug Class | Cardiac Glycoside |
Medical Subject Heading (MeSH) Categories for digoxin
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stevens J | DIGOXIN | digoxin | TABLET;ORAL | 076268-002 | Jul 26, 2002 | AB | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Abraxis Pharm | DIGOXIN | digoxin | INJECTABLE;INJECTION | 083217-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-004 | Sep 24, 1984 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Concordia | LANOXIN | digoxin | TABLET;ORAL | 020405-005 | Sep 30, 1997 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-002 | Jul 26, 1982 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Hikma Intl Pharms | DIGOXIN | digoxin | TABLET;ORAL | 077002-001 | Oct 30, 2007 | AB | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >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 | 018118-002 | Jul 26, 1982 | Try Before You Buy | Try Before You Buy |
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-004 | Sep 24, 1984 | Try Before You Buy | Try Before You Buy |
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-003 | Jul 26, 1982 | Try Before You Buy | Try Before You Buy |
| Glaxosmithkline Llc | LANOXICAPS | digoxin | CAPSULE;ORAL | 018118-001 | Jul 26, 1982 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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