GLYCINE - Generic Drug Details
What are the generic drug sources for glycine and what is the scope of patent protection?
Glycine
is the generic ingredient in two branded drugs marketed by Baxter Hlthcare, B Braun, Hospira, and Otsuka Icu Medcl, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for GLYCINE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 265 |
| Clinical Trials: | 135 |
| 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 |
|---|---|
| Janssen Research & Development, LLC | PHASE1 |
| National Institute on Aging (NIA) | Phase 4 |
| Vanderbilt University Medical Center | Phase 4 |
Medical Subject Heading (MeSH) Categories for GLYCINE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 018522-001 | Feb 19, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Otsuka Icu Medcl | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 018315-001 | Approved Prior to Jan 1, 1982 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| B Braun | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 016784-001 | Approved Prior to Jan 1, 1982 | AT | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | GLYCINE 1.5% IN PLASTIC CONTAINER | glycine | SOLUTION;IRRIGATION | 017633-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | ⤷ 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 |
