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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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