By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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IXEMPRA KIT Drug Profile
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When do Ixempra Kit patents expire, and when can generic versions of Ixempra Kit launch?
Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and thirteen patent family members in forty-five 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 July 23, 2022. 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
Summary for IXEMPRA KIT
| International Patents: | 213 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 52 |
| Clinical Trials: | 52 |
| Patent Applications: | 4,261 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for IXEMPRA KIT |
| DailyMed Link: | IXEMPRA KIT at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
|---|---|
| Yale University | Phase 2 |
| R-Pharm US, Inc. | Phase 2 |
| University of Texas Southwestern Medical Center | Phase 2 |
Paragraph IV (Patent) Challenges for IXEMPRA KIT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| IXEMPRA KIT | INJECTABLE;INTRAVENOUS | ixabepilone | 022065 | 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 | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| >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 | Get Started Free | Get Started Free |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | Get Started Free | Get Started Free |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | Get Started Free | Get Started Free |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | Get Started Free | Get Started Free |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | Get Started Free | Get Started Free |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IXEMPRA KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2004521122 | Get Started Free |
| Norway | 20033684 | Get Started Free |
| Norway | 20034056 | Get Started Free |
| Australia | 2002248542 | Get Started Free |
| Iceland | 6950 | Get Started Free |
| Hungary | 0303800 | Get Started Free |
| Bulgaria | 104068 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for IXEMPRA KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1019389 | C01019389/01 | Switzerland | Get Started Free | PRODUCT NAME: IXABEPILONE; REGISTRATION NUMBER/DATE: SWISSMEDIC 58880 27.02.2009 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
