Viewing data from:

MIRVASO

NDA

BRIMONIDINE TARTRATE | N204708 | GALDERMA LABORATORIES LP

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

2031

Today

Jun. 13, 2031

Jun. 13, 2031

Mar. 25, 2031

Mar. 25, 2031

Mar. 25, 2031

Mar. 25, 2031

Jun. 13, 2031

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Galderma Laboratories, L.P. et al v. Perrigo UK FINCO L.P. et al 1:2016cv00732 6 patentsANDA 209158brimonidine	D. Del.	2016-08-19	Terminated 2016-12-06	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Mirvaso (2023)

Total Spending

$899K

Total Claims

1,366

Beneficiaries

682

Avg Cost/Unit

$20.82

Spending Trend

$2.2M(2019)→$2.0M(2020)→$2.1M(2021)→$2.2M(2022)→$899K(2023)

YoY Change:+5.9%

5yr CAGR:+5.7%

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

API Supply Chain12 active DMFs1 inactive

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

FARMAK ASBRIMONIDINE TARTRATE

DMF 155852001

MEDICHEM SABRIMONIDINE TARTRATE

DMF 156012001

PIRAMAL PHARMA LTDBRIMONIDINE TARTRATE

DMF 175882004

FDC LTDBRIMONIDINE TARTRATE USP

DMF 208552007

INDOCO REMEDIES LTDBRIMONIDINE TARTRATE USP

DMF 221662008

SYMED LABS LTDBRIMONIDINE TARTRATE

DMF 222302008

C-SQUARED PHARMA LTDBRIMONIDINE TARTRATE

DMF 225102009

CENTAUR PHARMACEUTICALS PVT LTDBRIMONIDINE TARTRATE USP

DMF 238802010

SIEGFRIED GRAFTON INCBRIMONIDINE TARTRATE

DMF 242132010

UNICHEM LABORATORIES LTDBRIMONIDINE TARTRATE

DMF 250512011

MICRO LABS LTDBRIMONIDINE TARTRATE USP

DMF 343622019

MAITHRI DRUGS PRIVATE LTDBRIMONIDINE TARTRATE USP

DMF 365952021

LUPIN LTDInactiveBRIMONIDINE TARTRATE

DMF 252592011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 28, 2016	SUPPL -5	View Letter (PDF)
Aug 27, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.33% BASE

RLDAB

7 patents0 exclusivities▴

GEL;TOPICAL | Approved: Aug 23, 2013

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8053427	Jun 13, 2031	—	—	Yes		—
8163725	Jun 13, 2031	—	—	Yes	—	—
8513247	Mar 25, 2031	—	—	Yes		—
8513249	Mar 25, 2031	—	—	Yes		—
9861631	Mar 25, 2031	—	—	—		—
9861632	Mar 25, 2031	—	—	—		—
10201517	Jun 13, 2031	—	—	Yes	—	—