Details for New Drug Application (NDA): 022291
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The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 022291
Tradename: | PROMACTA |
Applicant: | Novartis |
Ingredient: | eltrombopag olamine |
Patents: | 6 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022291
Generic Entry Date for 022291*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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 NDA: 022291
Suppliers and Packaging for NDA: 022291
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291 | NDA | Novartis Pharmaceuticals Corporation | 0078-0684 | 0078-0684-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15) |
PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291 | NDA | Novartis Pharmaceuticals Corporation | 0078-0685 | 0078-0685-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG ACID | ||||
Approval Date: | Nov 20, 2008 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 16, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 13, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022291
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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