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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204803

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NDA 204803 describes POSIMIR, which is a drug marketed by Innocoll and is included in one NDA. There are six patents protecting this drug. Additional details are available on the POSIMIR profile page.

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

Medical Subject Heading (MeSH) Categories for 204803

Anesthetics, Local

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INFILTRATION			Strength	660MG/5ML (132MG/ML)
Approval Date:	Feb 1, 2021	TE:		RLD:	Yes
Patent:	11,400,019	Patent Expiration:	Jan 12, 2041	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,771,624	Patent Expiration:	Jan 12, 2041	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TO PRODUCE POST-SURGICAL ANALGESIA
Patent:	8,153,149	Patent Expiration:	Sep 15, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204803

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,153,149	⤷ Get Started Free
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,846,072	⤷ Get Started Free
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,753,665	⤷ Get Started Free
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,153,661	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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