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PROGLYCEM Drug Profile
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When do Proglycem patents expire, and what generic alternatives are available?
Proglycem is a drug marketed by Teva Branded Pharm and is included in two NDAs.
The generic ingredient in PROGLYCEM is diazoxide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diazoxide profile page.
US ANDA Litigation and Generic Entry Outlook for Proglycem
A generic version of PROGLYCEM was approved as diazoxide by E5 PHARMA INC on December 20th, 2019.
Summary for PROGLYCEM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,288 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROGLYCEM |
| DailyMed Link: | PROGLYCEM at DailyMed |
Recent Clinical Trials for PROGLYCEM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
| National Institutes of Health (NIH) | Phase 2 |
| Albert Einstein College of Medicine, Inc. | Phase 2 |
US Patents and Regulatory Information for PROGLYCEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROGLYCEM | diazoxide | CAPSULE;ORAL | 017425-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | PROGLYCEM | diazoxide | CAPSULE;ORAL | 017425-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Branded Pharm | PROGLYCEM | diazoxide | SUSPENSION;ORAL | 017453-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | 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 |
