Details for New Drug Application (NDA): 208854
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NDA 208854 describes SYMPROIC, which is a drug marketed by Bdsi and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SYMPROIC profile page.
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.
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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