DIDANOSINE Drug Patent Profile
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Which patents cover Didanosine, and when can generic versions of Didanosine launch?
Didanosine is a drug marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, and Aurobindo. and is included in five NDAs.
The generic ingredient in DIDANOSINE is didanosine. There are eight drug master file entries for this compound. Additional details are available on the didanosine profile page.
Summary for DIDANOSINE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 155 |
| Patent Applications: | 4,330 |
| Formulation / Manufacturing: | see details |
| 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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| 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 | ||||
| Aurobindo Pharma | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090094-004 | Sep 24, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | DIDANOSINE | didanosine | FOR SOLUTION;ORAL | 078112-001 | Mar 8, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
