ISOSORBIDE MONONITRATE Drug Patent Profile
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When do Isosorbide Mononitrate patents expire, and when can generic versions of Isosorbide Mononitrate launch?
Isosorbide Mononitrate is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, and Hikma Pharms. and is included in twenty NDAs.
The generic ingredient in ISOSORBIDE MONONITRATE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Isosorbide Mononitrate
A generic version of ISOSORBIDE MONONITRATE was approved as isosorbide mononitrate by CHARTWELL MOLECULAR on October 30th, 1998.
Summary for ISOSORBIDE MONONITRATE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 50 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ISOSORBIDE MONONITRATE |
| What excipients (inactive ingredients) are in ISOSORBIDE MONONITRATE? | ISOSORBIDE MONONITRATE excipients list |
| DailyMed Link: | ISOSORBIDE MONONITRATE at DailyMed |
See drug prices for ISOSORBIDE MONONITRATE
Recent Clinical Trials for ISOSORBIDE MONONITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Al-Azhar University | Early Phase 1 |
| Cairo University | Phase 1 |
| Aljazeera Hospital | Early Phase 1 |
Pharmacology for ISOSORBIDE MONONITRATE
| Drug Class | Nitrate Vasodilator |
| Physiological Effect | Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for ISOSORBIDE MONONITRATE
US Patents and Regulatory Information for ISOSORBIDE MONONITRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Elizabeth | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET;ORAL | 075037-001 | Oct 30, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Torrent Pharms | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 200495-001 | Jun 3, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Strides Pharma | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 090598-001 | Aug 11, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Torrent Pharms | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 200495-002 | Jun 3, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Strides Pharma | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 090598-002 | Aug 11, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Accord Hlthcare | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 209684-001 | Oct 24, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
