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
(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
(4 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
(4 years from now) | Active |
| US7816379 | Oxazolidinone derivatives |
Jun, 2028
(3 years from now) | Active |
| US8420676 | Oxazolidinone derivatives |
Feb, 2028
(2 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
(4 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
(4 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 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 |
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
Explore Our Curated Drug Screens
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 |
| |||||
| Baxter Hlthcare Corp |
| |||||
| Cubist Pharms Llc |
| |||||
| Cumberland |
| |||||
| Hikma |
| |||||
| Lg Chem Ltd |
| |||||
| Pfizer |
| |||||
| Pf Prism Cv |
| |||||
| Rempex |
| |||||
| Shionogi Inc |
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| Wyeth Pharms |
| |||||
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/VIAL | POWDER | Prescription | INTRAVENOUS |
| 200MG | TABLET | Prescription | ORAL |