ISOSORBIDE DINITRATE Drug Patent Profile
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Which patents cover Isosorbide Dinitrate, and what generic alternatives are available?
Isosorbide Dinitrate is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Endo Operations, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, and Riconpharma Llc. and is included in thirty-six NDAs.
The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
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Summary for ISOSORBIDE DINITRATE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 29 |
| Patent Applications: | 4,297 |
| Drug Prices: | Drug price information for ISOSORBIDE DINITRATE |
| What excipients (inactive ingredients) are in ISOSORBIDE DINITRATE? | ISOSORBIDE DINITRATE excipients list |
| DailyMed Link: | ISOSORBIDE DINITRATE at DailyMed |
Recent Clinical Trials for ISOSORBIDE DINITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Copenhagen University Hospital, Hvidovre | Phase 4 |
| Johannes Grand | Phase 4 |
| Bispebjerg Hospital | Phase 4 |
Pharmacology for ISOSORBIDE DINITRATE
| Drug Class | Nitrate Vasodilator |
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for ISOSORBIDE DINITRATE
Anatomical Therapeutic Chemical (ATC) Classes for ISOSORBIDE DINITRATE
US Patents and Regulatory Information for ISOSORBIDE DINITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;SUBLINGUAL | 086033-001 | Feb 26, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Lifesciences | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057-004 | Nov 20, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086034-001 | Jan 6, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Lifesciences | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057-005 | Nov 20, 2019 | AB | RX | 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 |
