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BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

ANDA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | A212212 | TEVA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SYMBICORT(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv01685 4 patentsANDA 212212budesonide/formoterol fumarate dihydrate	D. Del.	2018-10-26	Terminated 2019-12-04	—

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

Products (2)

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#001 — 0.08MG/INH;0.0045MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Apr 23, 2026

No patent or exclusivity listings for this strength.

#002 — 0.16MG/INH;0.0045MG/INH

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Apr 23, 2026