KYZATREX Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KYZATREX?
- What are the global sales for KYZATREX?
- What is Average Wholesale Price for KYZATREX?
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: | 1,479 |
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
Generic Entry Date for KYZATREX*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
CAPSULE;ORAL |
*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 ⤷ Subscribe.
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.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953-002 | Jul 27, 2022 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Marius Pharms Llc | KYZATREX | testosterone undecanoate | CAPSULE;ORAL | 213953-001 | Jul 27, 2022 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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
See the table below for patents covering KYZATREX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2013177454 | MODULATION OF SOLUBILITY, STABILITY, ABSORPTION, METABOLISM AND PHARMACOKINETIC PROFILE OF LIPOPHILIC DRUG BY STEROL | ⤷ Subscribe |
Hong Kong | 1219061 | 乳液製劑 (EMULSION FORMULATIONS) | ⤷ Subscribe |
Portugal | 2519230 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
KYZATREX Market Analysis and Financial Projection Experimental
More… ↓