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Didanosine - Generic Drug Details
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What are the generic drug sources for didanosine and what is the scope of patent protection?
Didanosine
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, Bristol Myers Squibb, Bristol-myers Squibb, and Aurobindo, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for didanosine. One supplier is listed for this compound.
Summary for didanosine
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 9 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 144 |
| Patent Applications: | 7,464 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in didanosine? | didanosine excipients list |
| DailyMed Link: | didanosine at DailyMed |
Recent Clinical Trials for didanosine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chang Gung Memorial Hospital | Phase 1 |
| TTY Biopharm | Phase 1 |
| Intergroupe Francophone de Cancerologie Thoracique | Phase 2 |
Pharmacology for didanosine
| Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for didanosine
Paragraph IV (Patent) Challenges for DIDANOSINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIDEX | FOR SOLUTION;ORAL | didanosine | 020155 | 2011-06-06 |
| VIDEX EC | CAPSULE, DELAYED REL PELLETS;ORAL | didanosine | 021183 | 2004-06-01 |
US Patents and Regulatory Information for didanosine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-002 | Oct 9, 1991 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-005 | Oct 9, 1991 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Barr | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 077167-003 | Dec 3, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Barr | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 077167-001 | Dec 3, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-006 | Oct 28, 1999 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 didanosine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol-myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020156-001 | Oct 9, 1991 | Start Trial | Start Trial |
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-005 | Oct 9, 1991 | Start Trial | Start Trial |
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-006 | Oct 9, 1991 | Start Trial | Start Trial |
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-005 | Oct 9, 1991 | Start Trial | Start Trial |
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-005 | Oct 9, 1991 | Start Trial | Start Trial |
| >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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