Viewing data from:

SYMPROIC

NDA

NALDEMEDINE TOSYLATE | N208854 | BIODELIVERY SCIENCES INTERNATIONAL INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (1)Active (4)Today

2027

2028

2029

2030

2031

2032

2033

Today

Feb. 24, 2031

Oct. 5, 2026

Nov. 11, 2031

May. 13, 2033

May. 13, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Symproic (2023)

Total Spending

$11.9M

Total Claims

22,736

Beneficiaries

5,113

Avg Cost/Unit

$15.19

Spending Trend

$3.7M(2019)→$8.6M(2020)→$10.5M(2021)→$12.1M(2022)→$11.9M(2023)

YoY Change:+5.1%

5yr CAGR:+5.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 16, 2025	SUPPL -7	View Letter (PDF)
Jan 30, 2018	SUPPL -2	View Letter (PDF)
Aug 2, 2017	SUPPL -1	View Letter (PDF)
Mar 24, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.2MG BASE

RLD

5 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 23, 2017

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46365	Feb 24, 2031	—	Yes	Yes	—	—
RE46375	Oct 5, 2026	—	Yes	Yes		—
9108975	Nov 11, 2031	—	Yes	Yes	—	—
10952968	May 13, 2033	—	Yes	Yes	—	—
12350377	May 13, 2033	—	—	Yes	—	—