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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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
*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 | 022065-002 | 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 | 022065-001 | 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 |
|---|---|---|---|
| Norway | 322494 | ⤷ Sign Up | |
| Israel | 156988 | ⤷ Sign Up | |
| China | 1496258 | ⤷ Sign Up | |
| Estonia | 04566 | Epotilooni derivaadid ja nende kasutamine meditsiinis | ⤷ Sign Up |
| South Africa | 200305126 | Methods of administering epothilone analogs for the treatment of cancer. | ⤷ 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 |
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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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