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Bupivacaine - Generic Drug Details
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This ingredient has twenty patent family members in fifteen countries.
There are ten drug master file entries for bupivacaine. One supplier is listed for this compound.
Summary for Generic Name: bupivacaine
| Tradenames: | 13 |
| Patents: | 3 |
| Applicants: | 9 |
| NDAs: | 38 |
| Drug Master File Entries: see list | 10 |
| Suppliers / Packaging: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: bupivacaine
| Ingredient-type | Amides |
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Clinical Trials for: bupivacaine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Claris | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 207266-001 | Jul 25, 2016 | RX | No | ||||||||||||||||||||||
Aurobindo Pharma Ltd | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 207183-002 | May 13, 2016 | RX | No | ||||||||||||||||||||||
Hospira | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | bupivacaine hydrochloride; epinephrine | INJECTABLE;INJECTION | 071166-001 | Jun 16, 1988 | DISCN | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: bupivacaine
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | 6,132,766 | <disabled> | ||||||||||||||||||||||
Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | 6,132,766 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: bupivacaine
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,045,824 | Sustained-release liposomal anesthetic compositions | <disabled in preview> | |||||||||||||||||||||||||||
| 9,192,575 | Sustained-release liposomal anesthetic compositions | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: bupivacaine
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 463238 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 2308470 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2001516714 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
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