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Last Updated: September 30, 2022

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: 14
Clinical Trials: 1
Patent Applications: 988
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
Drug Prices for KIMYRSA

See drug prices for KIMYRSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KIMYRSA
Generic Entry Date for KIMYRSA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
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

SponsorPhase
Melinta Therapeutics, Inc.Phase 1

See all KIMYRSA clinical trials

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 See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating bacterial infections using oritavancin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
Hungary E027373 See Plans and Pricing
Eurasian Patent Organization 020490 СПОСОБ ЛЕЧЕНИЯ БАКТЕРИАЛЬНОЙ ИНФЕКЦИИ (METHOD OF TREATMENT OF BACTERIAL INFECTION) See Plans and Pricing
Eurasian Patent Organization 201100413 СПОСОБ ЛЕЧЕНИЯ БАКТЕРИАЛЬНОЙ ИНФЕКЦИИ See Plans and Pricing
China 107206050 高纯度奥利万星及其生产方法 (High purity oritavancin and method of producing same) See Plans and Pricing
New Zealand 591525 Methods of treatment of complicated skin and skin structure infections using single doses of oritavancin See Plans and Pricing
Australia 2009285564 Methods of treatment using single doses of oritavancin See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KIMYRSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2337575 2016019 Norway See Plans and Pricing PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575 132016000101430 Italy See Plans and Pricing 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
2337575 300834 Netherlands See Plans and Pricing PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575 SPC/GB16/054 United Kingdom See Plans and Pricing PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY ORITAVANCIN DIPHOSPHATE.; REGISTERED: UK EU/1/15/989/001 20150323
2337575 1690041-7 Sweden See Plans and Pricing PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/15/989 20150323
2337575 41/2016 Austria See Plans and Pricing PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
McKinsey
Baxter
Colorcon
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.