Details for New Drug Application (NDA): 208854
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The generic ingredient in SYMPROIC is naldemedine tosylate. One supplier is listed for this compound. Additional details are available on the naldemedine tosylate profile page.
Summary for 208854
Tradename: | SYMPROIC |
Applicant: | Bdsi |
Ingredient: | naldemedine tosylate |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208854
Generic Entry Date for 208854*:
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: 208854
Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 208854
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854 | NDA | BioDelivery Sciences International Inc | 59385-041 | 59385-041-07 | 1 BLISTER PACK in 1 CARTON (59385-041-07) / 7 TABLET in 1 BLISTER PACK |
SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854 | NDA | BioDelivery Sciences International Inc | 59385-041 | 59385-041-30 | 30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.2MG BASE | ||||
Approval Date: | Mar 23, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 23, 2022 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 13, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 11, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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