ISOSORBIDE Drug Patent Profile
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Which patents cover Isosorbide, and what generic alternatives are available?
Isosorbide is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Hikma Intl Pharms, Ph Health, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, Ingenus Pharms Llc, 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, Genus, and Hikma Pharms. and is included in fifty-three NDAs.
The generic ingredient in ISOSORBIDE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Isosorbide
A generic version of ISOSORBIDE was approved as isosorbide mononitrate by CHARTWELL MOLECULAR on October 30th, 1998.
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Questions you can ask:
- What is the 5 year forecast for ISOSORBIDE?
- What are the global sales for ISOSORBIDE?
- What is Average Wholesale Price for ISOSORBIDE?
Summary for ISOSORBIDE
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 53 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strides Pharma Intl | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 090598-001 | Aug 11, 2010 | DISCN | No | 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 | ||||
| Zydus Lifesciences | ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057-004 | Nov 20, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Genus | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET;ORAL | 075037-002 | Oct 30, 1998 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Actavis Elizabeth | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 075306-002 | Dec 31, 1998 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma Intl Pharms | ISOSORBIDE MONONITRATE | isosorbide mononitrate | TABLET, EXTENDED RELEASE;ORAL | 076813-002 | Mar 30, 2006 | 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 |
