Sodium Thiosulfate is a drug owned by Hope Pharmaceuticals. It is protected by 5 US drug patents filed from 2013 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2031. Details of Sodium Thiosulfate'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. | |||
| US8496973 | Sodium thiosulfate-containing pharmaceutical compositions |
Mar, 2031
(5 years from now) | Active |
| US9345724 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(5 years from now) | Active |
| US9585912 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(5 years from now) | Active |
| US11753301 | Sodium thiosulfate-containing pharmaceutical compositions |
Feb, 2030
(4 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). | |||
| US10479686 | Sodium thiosulfate-containing pharmaceutical compositions |
Jul, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Sodium Thiosulfate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sodium Thiosulfate, 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 Sodium Thiosulfate.
Exclusivity Information
Sodium Thiosulfate holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Sodium Thiosulfate's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jan 14, 2018 |
| Orphan Drug Exclusivity(ODE-5) | Jan 14, 2018 |
Several oppositions have been filed on Sodium Thiosulfate'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 Sodium Thiosulfate's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sodium Thiosulfate patents.
Sodium Thiosulfate's Oppositions Filed in EPO
Sodium Thiosulfate has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 30, 2018, by Dr. Franz Köhler Chemie Gmbh. This opposition was filed on patent number EP10797770A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10797770A | Jul, 2018 | Shimamura, Naomi | Patent maintained as amended |
| EP10797770A | Jul, 2018 | Dr. Franz Köhler Chemie GmbH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Sodium Thiosulfate 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 Sodium Thiosulfate's family patents as well as insights into ongoing legal events on those patents.
Sodium Thiosulfate's Family Patents
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Generic Launch
Generic Release Date:
Sodium Thiosulfate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 29, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sodium Thiosulfate Generics:
There are no approved generic versions for Sodium Thiosulfate as of now.
How can I launch a generic of Sodium Thiosulfate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sodium Thiosulfate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sodium Thiosulfate's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Sodium Thiosulfate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 g/50 mL | 29 Apr, 2022 | 1 | 29 Mar, 2031 |
Alternative Brands for Sodium Thiosulfate
Sodium Thiosulfate which is used for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening., has several other brand drugs in the same treatment category and using the same active ingredient (Sodium Thiosulfate). 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 | ||
|---|---|---|---|---|
| Hope Pharms |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sodium Thiosulfate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Fennec Pharms Inc |
|
About Sodium Thiosulfate
Sodium Thiosulfate is a drug owned by Hope Pharmaceuticals. It is used for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. Sodium Thiosulfate uses Sodium Thiosulfate as an active ingredient. Sodium Thiosulfate was launched by Hope Pharms in 2012.
Approval Date:
Sodium Thiosulfate was approved by FDA for market use on 14 February, 2012.
Active Ingredient:
Sodium Thiosulfate uses Sodium Thiosulfate as the active ingredient. Check out other Drugs and Companies using Sodium Thiosulfate ingredient
Treatment:
Sodium Thiosulfate is used for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening.
Dosage:
Sodium Thiosulfate is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5GM/50ML (250MG/ML) | SOLUTION | Prescription | INTRAVENOUS |