Kimyrsa Patent Expiration

Kimyrsa is a drug owned by Melinta Therapeutics Llc. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 16, 2035. Details of Kimyrsa's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9649352 High purity oritavancin and method of producing same
Jul, 2035

(10 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8420592 Methods of treatment using single doses of oritavancin
Aug, 2029

(5 years from now)

Active
US9682061 Methods of treating bacterial infections using oritavancin
Apr, 2030

(5 years from now)

Active


FDA has granted several exclusivities to Kimyrsa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kimyrsa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Kimyrsa.

Exclusivity Information

Kimyrsa holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Kimyrsa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 06, 2019
New Product(NP) Mar 12, 2024
Generating Antibiotic Incentives Now(GAIN) Aug 06, 2024

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Several oppositions have been filed on Kimyrsa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Kimyrsa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kimyrsa patents.

Kimyrsa's oppositions filed in EPO

Kimyrsa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 13, 2017, by Prüfer & Partner Mbb. This opposition was filed on patent number EP09810708A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP09810708A Jan, 2017 Prüfer & Partner mbB Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Kimyrsa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Kimyrsa's family patents as well as insights into ongoing legal events on those patents.

Kimyrsa's family patents

Kimyrsa has patent protection in a total of 17 countries. It's US patent count contributes only to 29.8% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Kimyrsa.

Family Patents

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Generic Launch

Generic Release Date:

Kimyrsa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Kimyrsa Generics:

There are no approved generic versions for Kimyrsa as of now.





About Kimyrsa

Kimyrsa is a drug owned by Melinta Therapeutics Llc. It is used for treating acute bacterial skin and skin structure infections with a single dose of 1200mg of oritavancin or its equivalent. Kimyrsa uses Oritavancin Diphosphate as an active ingredient. Kimyrsa was launched by Melinta Therap in 2021.

Market Authorisation Date:

Kimyrsa was approved by FDA for market use on 12 March, 2021.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Kimyrsa is 12 March, 2021, its NCE-1 date is estimated to be 07 August, 2023

Active Ingredient:

Kimyrsa uses Oritavancin Diphosphate as the active ingredient. Check out other Drugs and Companies using Oritavancin Diphosphate ingredient

Treatment:

Kimyrsa is used for treating acute bacterial skin and skin structure infections with a single dose of 1200mg of oritavancin or its equivalent.

Dosage:

Kimyrsa is available in powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 1.2GM BASE/VIAL POWDER Prescription INTRAVENOUS