Details for New Drug Application (NDA): 210923
✉ Email this page to a colleague
The generic ingredient in MULPLETA is lusutrombopag. One supplier is listed for this compound. Additional details are available on the lusutrombopag profile page.
Summary for 210923
Tradename: | MULPLETA |
Applicant: | Vancocin Italia |
Ingredient: | lusutrombopag |
Patents: | 4 |
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: | 7,601,746 | Patent Expiration: | Sep 5, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC LIVER DISEASE WHO ARE SCHEDULED TO UNDERGO A PROCEDURE | ||||||||
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? |
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 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription