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Last Updated: July 16, 2024

Azurity Company Profile


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Summary for Azurity
International Patents:340
US Patents:86
Tradenames:31
Ingredients:24
NDAs:32
Patent Litigation for Azurity: See patent lawsuits for Azurity

Drugs and US Patents for Azurity

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes 9,855,215 ⤷  Sign Up Y ⤷  Sign Up
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes 10,154,987 ⤷  Sign Up ⤷  Sign Up
Azurity EPANED KIT enalapril maleate FOR SOLUTION;ORAL 204308-001 Aug 13, 2013 DISCN Yes No 8,778,366 ⤷  Sign Up ⤷  Sign Up
Azurity HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No 8,686,034 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 DISCN Yes No 10,130,580 ⤷  Sign Up Y ⤷  Sign Up
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-002 Jan 26, 2018 AB RX Yes Yes 10,959,946 ⤷  Sign Up Y ⤷  Sign Up
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes 10,959,991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Azurity

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 4,868,179 ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 10,130,580 ⤷  Sign Up
Azurity NYMALIZE nimodipine SOLUTION;ORAL 203340-002 Apr 8, 2020 8,517,997 ⤷  Sign Up
Azurity HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 8,048,917 ⤷  Sign Up
Azurity BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 6,465,463 ⤷  Sign Up
Azurity GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 4,757,128 ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 5,583,141 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for AZURITY drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe 2018-08-31
➤ Subscribe Powder for Oral Solution 1 mg/mL ➤ Subscribe 2016-06-21

Supplementary Protection Certificates for Azurity Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 PA2012004 Lithuania ⤷  Sign Up PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207
1718641 SPC/GB12/028 United Kingdom ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
0984957 SPC/GB11/013 United Kingdom ⤷  Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1718641 C01718641/01 Switzerland ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
0503785 C300486 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1718641 12C0034 France ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
1718641 C20120004 00052 Estonia ⤷  Sign Up PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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