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, Norvium Bioscience, 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.
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Summary for DIDANOSINE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 155 |
| Patent Applications: | 5,251 |
| DailyMed Link: | DIDANOSINE at DailyMed |
Recent Clinical Trials for DIDANOSINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| TTY Biopharm | Phase 1 |
| Chang Gung Memorial Hospital | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 077167-003 | Dec 3, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090094-004 | Sep 24, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | DIDANOSINE | didanosine | FOR SOLUTION;ORAL | 078112-001 | Mar 8, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | DIDANOSINE | didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 090788-001 | Apr 8, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo | DIDANOSINE | didanosine | TABLET, FOR SUSPENSION;ORAL | 077275-002 | Aug 14, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
