Sivextro Patent Expiration

Sivextro is a drug owned by Cubist Pharmaceuticals Llc. It is protected by 7 US drug patents filed from 2014 to 2019 out of which none have expired yet. Sivextro's patents have been open to challenges since 21 June, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 31, 2030. Details of Sivextro's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8426389 Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Dec, 2030

(6 years from now)

Active
US10442829 Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Feb, 2030

(5 years from now)

Active
US9624250 Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Feb, 2030

(5 years from now)

Active
US7816379 Oxazolidinone derivatives
Jun, 2028

(3 years from now)

Active
US8420676 Oxazolidinone derivatives
Feb, 2028

(3 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9988406 Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Feb, 2030

(5 years from now)

Active
US10065947 Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Feb, 2030

(5 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Sivextro's patents.

Given below is the list of recent legal activities going on the following patents of Sivextro.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 09 Mar, 2023 US10442829
Payment of Maintenance Fee, 12th Year, Large Entity 09 Mar, 2022 US7816379
Payment of Maintenance Fee, 4th Year, Large Entity 09 Feb, 2022 US10065947
Payment of Maintenance Fee, 4th Year, Large Entity 11 Nov, 2021 US9988406
Payment of Maintenance Fee, 8th Year, Large Entity 15 Sep, 2020 US8426389
Payment of Maintenance Fee, 4th Year, Large Entity 15 Sep, 2020 US9624250
Payment of Maintenance Fee, 8th Year, Large Entity 15 Sep, 2020 US8420676
Patent Term Extension Certificate 29 Jul, 2020 US7816379
Notice of Final Determination -Eligible 13 Apr, 2020 US7816379
Notice of Final Determination -Eligible 19 Feb, 2020 US7816379


FDA has granted several exclusivities to Sivextro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sivextro, 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 Sivextro.

Exclusivity Information

Sivextro holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Sivextro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 20, 2019
New Patient Population(NPP) Jun 19, 2023
Generating Antibiotic Incentives Now(GAIN) Jun 20, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Sivextro 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 Sivextro's family patents as well as insights into ongoing legal events on those patents.

Sivextro's Family Patents

Sivextro has patent protection in a total of 39 countries. It's US patent count contributes only to 20.5% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Sivextro.

Family Patents

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Generic Launch

Generic Release Date:

Sivextro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 31, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Sivextro Generics:

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

Alternative Brands for Sivextro

Sivextro which is used for treating acute bacterial skin and skin structure infections caused by susceptible bacteria., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Abbvie
Teflaro Used for treating bacterial infections.
Baxter Hlthcare Corp
Zosyn In Plastic Container used for treating bacterial infections.
Cubist Pharms Llc
Cubicin Used for treating bacterial infections, including skin infections and bloodstream infections.
Cumberland
Vibativ Used for treating bacterial infections, including staphylococcal infections.
Lg Chem Ltd
Factive used for treating various bacterial infections.
Pfizer
Trovan Used for treating bacterial infections.
Trovan Preservative Free Used for treating bacterial infections.
Pf Prism Cv
Zmax used for treating bacterial infections.
Tygacil Used for treating bacterial infections.
Rempex
Minocin used for treating bacterial infections.
Shionogi Inc
Doribax Used for treating bacterial infections.
Wyeth Pharms
Zosyn Used for treating bacterial infections.
Xellia Pharms Aps
Vancomycin Used for treating bacterial infections.
Vancomycin Hydrochloride Used for treating bacterial infections.





About Sivextro

Sivextro is a drug owned by Cubist Pharmaceuticals Llc. It is used for treating acute bacterial skin and skin structure infections caused by susceptible bacteria. Sivextro uses Tedizolid Phosphate as an active ingredient. Sivextro was launched by Cubist Pharms Llc in 2014.

Approval Date:

Sivextro was approved by FDA for market use on 20 June, 2014.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Sivextro is 20 June, 2014, its NCE-1 date is estimated to be 21 June, 2023.

Active Ingredient:

Sivextro uses Tedizolid Phosphate as the active ingredient. Check out other Drugs and Companies using Tedizolid Phosphate ingredient

Treatment:

Sivextro is used for treating acute bacterial skin and skin structure infections caused by susceptible bacteria.

Dosage:

Sivextro is available in the following dosage forms - powder form for intravenous use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG TABLET Prescription ORAL
200MG/VIAL POWDER Prescription INTRAVENOUS