Viewing data from:

NATROBA

NDA

SPINOSAD | N022408 | CIPHER PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

9895388

Nov. 25, 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 Natroba (2023)

Total Spending

$131K

Total Claims

430

Beneficiaries

313

Avg Cost/Unit

$2.33

Spending Trend

$54K(2019)→$83K(2020)→$51K(2021)→$99K(2022)→$131K(2023)

YoY Change:+0.4%

5yr CAGR:+1.4%

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

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

CORTEVA AGRISCIENCE LLCSPINOSAD PHARMACEUTICAL GRADE

DMF 177952004

CHONGQING QIANTAI PHARMA CO LTDSPINOSAD

DMF 362932021

QILU PHARMACEUTICAL HULUN BUIR BRANCHSPINOSAD INTERMEDIATE (NON-STERILE, VETERINARY GRADE)

DMF 363242022

CHEMWERTH INCSPINOSAD

DMF 367072022

QUIMICA SINTETICA SASPINOSAD

DMF 400752024

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 30, 2021	SUPPL -10	View Letter (PDF)
Jan 7, 2015	SUPPL -5	View Letter (PDF)
Jan 20, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.9%

RLD

1 patent0 exclusivities▴

SUSPENSION;TOPICAL | Approved: Jan 18, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9895388	Nov 25, 2033	—	—	—		—