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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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 6, 2024. This may change due to patent challenges or generic licensing.

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:	30
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

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

Generic Entry Date for KIMYRSA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW NDA: 214155 Dosage: POWDER;INTRAVENOUS

^*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.

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

Anatomical Therapeutic Chemical (ATC) Classes for KIMYRSA

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for KIMYRSA

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

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

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.
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 KIMYRSA

Methods of treatment using single doses of oritavancin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods of treating bacterial infections using oritavancin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
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
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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
World Intellectual Property Organization (WIPO)	2010129233		⤷ Try a Trial
Japan	6712991		⤷ Try a Trial
Brazil	112017000898	oritavancina de alta pureza e método de produção da mesma	⤷ Try a Trial
>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	2016019	Norway	⤷ Try a Trial	PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575	1690041-7	Sweden	⤷ Try a Trial	PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/15/989 20150323
2337575	300834	Netherlands	⤷ Try a Trial	PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description