Details for New Drug Application (NDA): 210923
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NDA 210923 describes MULPLETA, which is a drug marketed by Vancocin Italia and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the MULPLETA profile page.
The generic ingredient in MULPLETA is lusutrombopag. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lusutrombopag profile page.
The generic ingredient in MULPLETA is lusutrombopag. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lusutrombopag profile page.
Summary for 210923
| Tradename: | MULPLETA |
| Applicant: | Vancocin Italia |
| Ingredient: | lusutrombopag |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210923
Generic Entry Date for 210923*:
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.
Suppliers and Packaging for NDA: 210923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MULPLETA | lusutrombopag | TABLET;ORAL | 210923 | NDA | SHIONOGI INC. | 59630-551 | 59630-551-07 | 1 DOSE PACK in 1 CARTON (59630-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK |
| MULPLETA | lusutrombopag | TABLET;ORAL | 210923 | NDA | SHIONOGI INC. | 59630-551 | 59630-551-77 | 1 DOSE PACK in 1 CARTON (59630-551-77) / 7 TABLET, FILM COATED in 1 DOSE PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Jul 31, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 8,530,668 | Patent Expiration: | Jan 21, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,889,722 | Patent Expiration: | Jul 29, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 9,427,402 | Patent Expiration: | Sep 29, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210923
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | 7,601,746 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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