Isosorbide - Generic Drug Details
What are the generic sources for isosorbide and what is the scope of patent protection?
Isosorbide
is the generic ingredient in nine branded drugs marketed by Alcon, Endo Operations, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms, Hikma, Ph Health, Rubicon Research, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Biovail, Watson Labs Teva, Schering Plough, Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma Intl, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Promius Pharma, Genus, and Omnivium Pharms, and is included in sixty-five NDAs. Additional information is available in the individual branded drug profile pages.Summary for isosorbide
| US Patents: | 0 |
| Tradenames: | 9 |
| Applicants: | 37 |
| NDAs: | 65 |
| Drug Master File Entries: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 78 |
| Drug Prices: | Drug price trends for isosorbide |
| DailyMed Link: | isosorbide at DailyMed |
Recent Clinical Trials for isosorbide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Beijing Tiantan Hospital | PHASE3 |
| Shenzhen Second People's Hospital | PHASE3 |
| Ruijin Hospital | PHASE4 |
Medical Subject Heading (MeSH) Categories for isosorbide
US Patents and Regulatory Information for isosorbide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Omnivium Pharms | MONOKET | isosorbide mononitrate | TABLET;ORAL | 020215-001 | Jun 30, 1993 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Astrazeneca | SORBITRATE | isosorbide dinitrate | TABLET;SUBLINGUAL | 016191-002 | Apr 1, 1996 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Labs Teva | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;SUBLINGUAL | 086031-001 | Sep 29, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Omnivium Pharms | MONOKET | isosorbide mononitrate | TABLET;ORAL | 020215-002 | Jun 30, 1993 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET;ORAL | 075361-001 | Oct 5, 2000 | DISCN | No | 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 |
