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BREYNA

ANDA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | A211699 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SYMBICORT(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2022cv00035 5 patentsANDA 211699budesonide/formoterol fumarate dihydrate	WVND	2022-04-26	Terminated 2023-03-08	—
AstraZeneca AB et al v. Mylan Pharmaceuticals Inc. et al 1:2018cv00193 4 patentsANDA 211699budesonide/formoterol fumarate dihydrate	WVND	2018-10-12	Terminated 2023-03-08	—

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

Medicare Part D Spending

CMS annual spending data for Breyna (2023)

Total Spending

$8.4M

Total Claims

29,160

Beneficiaries

22,119

Avg Cost/Unit

$19.39

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 3, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.08MG/INH;0.0045MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Mar 15, 2022

No patent or exclusivity listings for this strength.

#002 — 0.16MG/INH;0.0045MG/INH

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Mar 15, 2022