AXTLE Drug Patent Profile
When do Axtle patents expire, and when can generic versions of Axtle launch?
Axtle is a drug marketed by Avyxa Holdings and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in AXTLE is pemetrexed dipotassium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed dipotassium profile page.
DrugPatentWatch® Generic Entry Outlook for Axtle
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 25, 2045. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for AXTLE?
- What are the global sales for AXTLE?
- What is Average Wholesale Price for AXTLE?
Summary for AXTLE
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 3,548 |
| What excipients (inactive ingredients) are in AXTLE? | AXTLE excipients list |
| DailyMed Link: | AXTLE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AXTLE
Generic Entry Date for AXTLE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS |
*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.
Pharmacology for AXTLE
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for AXTLE
AXTLE is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AXTLE is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avyxa Holdings | AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661-001 | Jun 28, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Avyxa Holdings | AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661-002 | Jun 28, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
