KYZATREX Drug Patent Profile
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When do Kyzatrex patents expire, and what generic alternatives are available?
Kyzatrex is a drug marketed by Marius Pharms Llc and is included in one NDA. There are four patents protecting this drug.
This drug has twenty patent family members in eleven countries.
The generic ingredient in KYZATREX is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
DrugPatentWatch® Generic Entry Outlook for Kyzatrex
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 27, 2025. This may change due to patent challenges or generic licensing.
There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for KYZATREX
| International Patents: | 20 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,450 |
| Drug Prices: | Drug price information for KYZATREX |
| What excipients (inactive ingredients) are in KYZATREX? | KYZATREX excipients list |
| DailyMed Link: | KYZATREX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KYZATREX
*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 KYZATREX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| San Diego Sexual Medicine | Phase 2 |
Pharmacology for KYZATREX
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
US Patents and Regulatory Information for KYZATREX
KYZATREX is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KYZATREX is ⤷ Sign Up.
This potential generic entry date is based on NEW PRODUCT.
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 KYZATREX
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TESTOSTERONE DEFICIENCY
FDA Regulatory Exclusivity protecting KYZATREX
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953-001 | Jul 27, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953-002 | Jul 27, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953-001 | Jul 27, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 KYZATREX
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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.
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