IXEMPRA KIT Drug Patent Profile
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Which patents cover Ixempra Kit, and what generic alternatives are available?
Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-four patent family members in twenty-six countries.
The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ixabepilone profile page.
DrugPatentWatch® Generic Entry Outlook for Ixempra Kit
Ixempra Kit was eligible for patent challenges on October 16, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 21, 2025. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
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Summary for IXEMPRA KIT
International Patents: | 34 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 55 |
Patent Applications: | 6,496 |
Drug Prices: | Drug price information for IXEMPRA KIT |
DailyMed Link: | IXEMPRA KIT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IXEMPRA KIT
Generic Entry Date for IXEMPRA KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;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.
Recent Clinical Trials for IXEMPRA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
R-Pharm-US, LLC | Phase 2 |
R-Pharm US, Inc. | Phase 2 |
Yale University | Phase 2 |
Paragraph IV (Patent) Challenges for IXEMPRA KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
IXEMPRA KIT | Injection | ixabepilone | 15 mg/vial and 45 mg/vial, single- use vials | 022065 | 1 | 2012-04-16 |
US Patents and Regulatory Information for IXEMPRA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for IXEMPRA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IXEMPRA KIT
See the table below for patents covering IXEMPRA KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I250017 | ⤷ Sign Up | |
European Patent Office | 1353667 | ⤷ Sign Up | |
Norway | 335119 | ⤷ Sign Up | |
Malaysia | 124151 | EPOTHILONE DERIVATIVES | ⤷ Sign Up |
Israel | 156988 | ⤷ Sign Up | |
Canada | 2434566 | ⤷ Sign Up | |
Bulgaria | 66494 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IXEMPRA KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1019389 | C01019389/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: IXABEPILONE; REGISTRATION NUMBER/DATE: SWISSMEDIC 58880 27.02.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |