Rocuronium bromide - Generic Drug Details
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What are the generic drug sources for rocuronium bromide and what is the scope of patent protection?
Rocuronium bromide
is the generic ingredient in two branded drugs marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hong Kong, Hospira, Mylan Institutional, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Tamarang, Teva Pharms, West Ward Pharm Corp, and Organon Usa Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for rocuronium bromide. Twenty-two suppliers are listed for this compound.
Summary for rocuronium bromide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 16 |
| NDAs: | 16 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 57 |
| Patent Applications: | 906 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in rocuronium bromide? | rocuronium bromide excipients list |
| DailyMed Link: | rocuronium bromide at DailyMed |
Recent Clinical Trials for rocuronium bromide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chosun University Hospital | N/A |
| Assiut University | Phase 2/Phase 3 |
| Yangzhou University | N/A |
Pharmacology for rocuronium bromide
| Drug Class | Nondepolarizing Neuromuscular Blocker |
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Anatomical Therapeutic Chemical (ATC) Classes for rocuronium bromide
US Patents and Regulatory Information for rocuronium bromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 078519-001 | Nov 26, 2008 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 079195-002 | Dec 5, 2008 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Prinston Inc | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 212668-001 | May 26, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| West Ward Pharm Corp | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 204679-002 | Feb 28, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sagent Pharms Inc | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 091458-002 | Jul 28, 2010 | AP | 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 |
Expired US Patents for rocuronium bromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-001 | Mar 17, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-003 | Mar 17, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Inc | ZEMURON | rocuronium bromide | INJECTABLE;INJECTION | 020214-002 | Mar 17, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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