ISOSORBIDE DINITRATE - Generic Drug Details
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What are the generic sources for isosorbide dinitrate and what is the scope of freedom to operate?
Isosorbide dinitrate
is the generic ingredient in four branded drugs marketed by Endo Operations, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Biovail, and Watson Labs Teva, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for isosorbide dinitrate. Twenty-two suppliers are listed for this compound.
Summary for ISOSORBIDE DINITRATE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 16 |
| NDAs: | 44 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 29 |
| Patent Applications: | 6,245 |
| Drug Prices: | Drug price trends 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 |
|---|---|
| Johannes Grand | Phase 4 |
| Bispebjerg Hospital | Phase 4 |
| Zealand University 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093-006 | Jul 29, 1988 | DISCN | Yes | 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 | |||
| Zydus Lifesciences | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057-004 | Nov 20, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;SUBLINGUAL | 086225-001 | Feb 19, 1988 | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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