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Information, Expiry & Status of FDA Orange Book Patents covering Viatris brand of azelastine hydrochloride

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01

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8518919

Drug Substance Claim :

Drug Product Claim :

Application Number : 213872

Patent Use Code : U-3166

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-22

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02

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8518919

Drug Substance Claim :

Drug Product Claim :

Application Number : 213872

Patent Use Code : U-3166

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-22

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03

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8071073

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213872

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-06-04

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04

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8071073

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213872

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-06-04

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05

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 9919050

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213872

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-22

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06

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 9919050

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213872

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-22

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07

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8518919

Drug Substance Claim :

Drug Product Claim :

Application Number : 22203

Patent Use Code : U-1430

Delist Requested :

Patent Use Description : TREATMENT OF ALLERGIC ...

Patent Expiration Date : 2025-11-22

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08

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8518919

Drug Substance Claim :

Drug Product Claim :

Application Number : 22203

Patent Use Code : U-1430

Delist Requested :

Patent Use Description : TREATMENT OF ALLERGIC ...

Patent Expiration Date : 2025-11-22

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09

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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

US Patent Number : 8168620

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 202236

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-02-24

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10

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FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

AZELASTINE HYDROCHLORIDE

US Patent Number : 8071073

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 22203

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-06-04

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