Isosorbide - Generic Drug Details
✉ Email this page to a colleague
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 Intl Pharms, 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, Hikma Pharms, 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkermes Gainesville | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075041-001 | Sep 22, 1998 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Superpharm | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 089190-001 | Feb 17, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Skyepharma Ag | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075166-001 | Oct 7, 1999 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093-002 | Jul 29, 1988 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Labs | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;SUBLINGUAL | 086033-001 | Feb 26, 1988 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Torrent Pharms | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 200495-002 | Jun 3, 2011 | AB | RX | 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 |
