Glycine - Generic Drug Details
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What are the generic drug sources for glycine and what is the scope of freedom to operate?
Glycine
is the generic ingredient in two branded drugs marketed by Baxter Hlthcare, B Braun, Hospira, and Icu Medical Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are thirty drug master file entries for glycine. Three suppliers are listed for this compound.
Summary for glycine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 30 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 265 |
| Clinical Trials: | 129 |
| Patent Applications: | 819 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in glycine? | glycine excipients list |
| DailyMed Link: | glycine at DailyMed |
Recent Clinical Trials for glycine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 1/Phase 2 |
| Indiana University | Early Phase 1 |
| Alexandria University | Phase 4 |
Medical Subject Heading (MeSH) Categories for glycine
US Patents and Regulatory Information for glycine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Icu Medical Inc | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 018315-001 | Approved Prior to Jan 1, 1982 | AT | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare | AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 017865-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 018522-001 | Feb 19, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hospira | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 017633-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| B Braun | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 016784-001 | Approved Prior to Jan 1, 1982 | AT | RX | 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 |
