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POSIMIR Drug Patent Profile

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When do Posimir patents expire, and what generic alternatives are available?

Posimir is a drug marketed by Innocoll and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-one patent family members in twenty-nine countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Posimir

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2041. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for POSIMIR

International Patents:	61
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	4,363
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in POSIMIR?	POSIMIR excipients list
DailyMed Link:	POSIMIR at DailyMed

Drug patent expirations by year for POSIMIR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for POSIMIR

Generic Entry Date for POSIMIR^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 204803 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 POSIMIR

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for POSIMIR

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for POSIMIR

POSIMIR is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of POSIMIR is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting POSIMIR

Sustained release drug delivery systems with reduced impurities and related methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO PRODUCE POST-SURGICAL ANALGESIA

Controlled delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Controlled delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR PROVIDING SUSTAINED LOCAL ANESTHESIA FOR AT LEAST 24 HOURS

FDA Regulatory Exclusivity protecting POSIMIR

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Innocoll	POSIMIR	bupivacaine	SOLUTION, EXTENDED RELEASE;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for POSIMIR

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586 Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.	Authorised	no	no	no	2020-11-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for POSIMIR

When does loss-of-exclusivity occur for POSIMIR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Patent: 2022013784
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 67217
Estimated Expiration: ⤷ Try a Trial

China

Patent: 5666621
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 90353
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 23515918
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 220140711
Estimated Expiration: ⤷ Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering POSIMIR around the world.

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Country	Patent Number	Title	Estimated Expiration
Poland	2415484		⤷ Try a Trial
Hungary	E032040		⤷ Try a Trial
Russian Federation	2007114291	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ	⤷ Try a Trial
Cyprus	1116531		⤷ Try a Trial
Israel	181474	מערכת למתן מבוקר (Controlled delivery system)	⤷ Try a Trial
Slovenia	1809329		⤷ Try a Trial
European Patent Office	2767292	Composition anesthésique locale prolongée contenant du SAIB (Sustained Local Anesthetic Composition Containing SAIB)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration