Viewing data from:

SYNAREL

NDA

NAFARELIN ACETATE | N019886 | PFIZER INC

1 strength0 unique patents0 unique exclusivities

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 Synarel (2023)

Total Spending

$204K

Total Claims

Beneficiaries

Avg Cost/Unit

$391.47

Spending Trend

$286K(2019)→$365K(2020)→$260K(2021)→$212K(2022)→$204K(2023)

YoY Change:+3.5%

5yr CAGR:+2.3%

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

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CARLSBERG BIOTECHNOLOGY LTDInactiveNAFARELIN ACETATE

DMF 60491985

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.2MG BASE/SPRAY

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Feb 13, 1990

No patent or exclusivity listings for this strength.