Details for New Drug Application (NDA): 022496
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NDA 022496 describes EXPAREL, which is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the EXPAREL profile page.
The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
Summary for 022496
| Tradename: | EXPAREL |
| Applicant: | Pacira Pharms Inc |
| Ingredient: | bupivacaine |
| Patents: | 13 |
Pharmacology for NDA: 022496
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 022496
Suppliers and Packaging for NDA: 022496
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496 | NDA | Pacira Pharmaceuticals, Inc. | 65250-133 | 65250-133-04 | 4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10) |
| EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496 | NDA | Pacira Pharmaceuticals, Inc. | 65250-133 | 65250-133-09 | 10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 133MG/10ML (13.3MG/ML) | ||||
| Approval Date: | Oct 28, 2011 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Nov 9, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA A SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 22, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA | ||||||||
Expired US Patents for NDA 022496
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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