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KIMYRSA Drug Patent Profile

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Which patents cover Kimyrsa, and what generic alternatives are available?

Kimyrsa is a drug marketed by Melinta Therap and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in seventeen countries.

The generic ingredient in KIMYRSA is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kimyrsa

Kimyrsa was eligible for patent challenges on August 6, 2018.

Indicators of Generic Entry

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Summary for KIMYRSA

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	2
Patent Applications:	25
Drug Prices:	Drug price information for KIMYRSA
What excipients (inactive ingredients) are in KIMYRSA?	KIMYRSA excipients list
DailyMed Link:	KIMYRSA at DailyMed

Drug patent expirations by year for KIMYRSA

Recent Clinical Trials for KIMYRSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Melinta Therapeutics, Inc.	Phase 2
Melinta Therapeutics, Inc.	Phase 1

See all KIMYRSA clinical trials

Pharmacology for KIMYRSA

Drug Class	Lipoglycopeptide Antibacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for KIMYRSA

KIMYRSA is protected by three US patents and three FDA Regulatory Exclusivities.

Patents protecting KIMYRSA

Methods of treatment using single doses of oritavancin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT

High purity oritavancin and method of producing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods of treating bacterial infections using oritavancin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT

FDA Regulatory Exclusivity protecting KIMYRSA

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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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
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for KIMYRSA

See the table below for patents covering KIMYRSA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	5782615		⤷ Sign Up
Japan	2012501349		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016011245		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010025438		⤷ Sign Up
Australia	2015289602	High purity oritavancin and method of producing same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for KIMYRSA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	CA 2016 00044	Denmark	⤷ Sign Up	PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575	2016/040	Ireland	⤷ Sign Up	PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	41/2016	Austria	⤷ Sign Up	PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
2337575	16C0039	France	⤷ Sign Up	PRODUCT NAME: ORITAVANCINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,TELS QUE LES SELS DIPHOSPHATES; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575	132016000101430	Italy	⤷ Sign Up	PRODUCT NAME: ORITAVANCINA E I SUOI SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE IL DIFOSFATO(ORBACTIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/989, 20150323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description