Didanosine - Generic Drug Details
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What are the generic sources for didanosine and what is the scope of freedom to operate?
Didanosine
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, Bristol Myers Squibb, Bristol, 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.
Summary for didanosine
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 9 |
| Drug Master File Entries: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 155 |
| Patent Applications: | 7,345 |
| 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 |
| Asan Medical Center | Phase 4 |
Medical Subject Heading (MeSH) Categories for didanosine
Paragraph IV (Patent) Challenges for DIDANOSINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIDEX | Capsules | didanosine | 75 mg | 020155 | 1 | 2011-06-06 |
| VIDEX EC | Delayed-release Capsules | didanosine | 200 mg, 250 mg and 400 mg | 021183 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090788-001 | Apr 8, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-005 | Oct 9, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090094-001 | Sep 24, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-006 | Oct 9, 1991 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | VIDEX EC | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 021183-004 | Oct 31, 2000 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Barr | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 077167-003 | Dec 3, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Pharms Inc | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090788-002 | Apr 8, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 EC | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 021183-002 | Oct 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX EC | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 021183-002 | Oct 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-005 | Oct 9, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX EC | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 021183-003 | Oct 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX | didanosine | FOR SOLUTION;ORAL | 020155-005 | Oct 9, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-005 | Oct 9, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | VIDEX | didanosine | TABLET, CHEWABLE;ORAL | 020154-003 | Oct 9, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
