Details for New Drug Application (NDA): 022065
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NDA 022065 describes IXEMPRA KIT, which is a drug marketed by R-pharm Us Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the IXEMPRA KIT profile page.
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.
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.
Summary for 022065
| Tradename: | IXEMPRA KIT |
| Applicant: | R-pharm Us Llc |
| Ingredient: | ixabepilone |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022065
Generic Entry Date for 022065*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 022065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065 | NDA | R-Pharm US Operating, LLC | 70020-1910 | 70020-1910-1 | 1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE |
| IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065 | NDA | R-Pharm US Operating, LLC | 70020-1911 | 70020-1911-1 | 1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 15MG/VIAL | ||||
| Approval Date: | Oct 16, 2007 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 45MG/VIAL | ||||
| Approval Date: | Oct 16, 2007 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022065
| 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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