Details for New Drug Application (NDA): 204803
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The generic ingredient in POSIMIR 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 204803
Tradename: | POSIMIR |
Applicant: | Innocoll |
Ingredient: | bupivacaine |
Patents: | 6 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204803
Generic Entry Date for 204803*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, EXTENDED RELEASE;INFILTRATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 204803
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 204803
Suppliers and Packaging for NDA: 204803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSIMIR | bupivacaine | SOLUTION, EXTENDED RELEASE;INFILTRATION | 204803 | NDA | Renaissance Lakewood, LLC | 49396-6601 | 49396-6601-0 | 10 BOTTLE in 1 CARTON (49396-6601-0) / 5 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, EXTENDED RELEASE;INFILTRATION | Strength | 660MG/5ML (132MG/ML) | ||||
Approval Date: | Feb 1, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 1, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 12, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 12, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TO PRODUCE POST-SURGICAL ANALGESIA |
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