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Bupivacaine - Generic Drug Details
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What are the generic sources for bupivacaine and what is the scope of patent protection?
Bupivacaine
is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Innocoll Pharms, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupivacaine has nineteen patent family members in nine countries.
There are twelve drug master file entries for bupivacaine. One supplier is listed for this compound.
Summary for bupivacaine
| International Patents: | 19 |
| US Patents: | 2 |
| Tradenames: | 13 |
| Applicants: | 13 |
| NDAs: | 42 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 1,267 |
| Patent Applications: | 4,593 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for bupivacaine |
| DailyMed Link: | bupivacaine at DailyMed |
Recent Clinical Trials for bupivacaine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laval University | Phase 3 |
| CHU de Quebec-Universite Laval | Phase 3 |
| Benha University | N/A |
Pharmacology for bupivacaine
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for bupivacaine
US Patents and Regulatory Information for bupivacaine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 203895-002 | Nov 5, 2013 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hospira | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | bupivacaine hydrochloride; epinephrine | INJECTABLE;INJECTION | 071171-001 | Jun 16, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Huons | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 212822-001 | Dec 30, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Asi | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487-001 | Oct 18, 2011 | 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 |
Expired US Patents for bupivacaine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | Start Trial | Start Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | Start Trial | Start Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | Start Trial | Start Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bupivacaine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9925319 | Start Trial |
| Japan | 2010285438 | Start Trial |
| Australia | 1407599 | Start Trial |
| Canada | 2309548 | Start Trial |
| >Country | >Patent Number | >Estimated 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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