Last Updated: September 28, 2026

Azurity Company Profile


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What is the competitive landscape for AZURITY

AZURITY has fifty-nine approved drugs.

There are one hundred and sixty-seven US patents protecting AZURITY drugs. There are two tentative approvals on AZURITY drugs.

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 EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 DISCN Yes No 11,896,562 ⤷  Start Trial ⤷  Start Trial
Azurity ZONISADE zonisamide SUSPENSION;ORAL 214273-001 Jul 15, 2022 RX Yes Yes 12,491,179 ⤷  Start Trial Y ⤷  Start Trial
Azurity ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes 10,722,667 ⤷  Start Trial Y ⤷  Start Trial
Azurity EPANED enalapril maleate SOLUTION;ORAL 208686-001 Sep 20, 2016 AB RX Yes Yes 11,141,405 ⤷  Start Trial Y ⤷  Start Trial
Azurity FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-001 Jan 26, 2018 AA RX Yes Yes 10,959,947 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 DISCN Yes No 11,896,562 ⤷  Start Trial ⤷  Start Trial
>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 EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 10,130,580 ⤷  Start Trial
Azurity ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-002 Jun 26, 2002 6,485,748 ⤷  Start Trial
Azurity CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 8,815,889 ⤷  Start Trial
Azurity ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 6,264,923 ⤷  Start Trial
Azurity DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 7,078,412 ⤷  Start Trial
Azurity DUAKLIR PRESSAIR aclidinium bromide; formoterol fumarate POWDER, METERED;INHALATION 210595-001 Mar 29, 2019 9,333,195 ⤷  Start Trial
>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 Nasal Spray 250 mcg ➤ Subscribe 2012-02-13
➤ Subscribe Extended-release Tablets 20 mg and 30 mg ➤ Subscribe 2007-11-07
➤ Subscribe Extended-release Tablets 40 mg ➤ Subscribe 2007-06-11
➤ Subscribe Extended-release Tablets 300 mg ➤ Subscribe 2006-05-19
➤ Subscribe Injection 30 mg/mL, 17 mL single-use vials ➤ Subscribe 2015-12-04
➤ Subscribe Oral Solution 17.5 g/3.13 g/1.6 g per bottle ➤ Subscribe 2010-11-08
➤ Subscribe Extended-release Tablets 8 mg/90 mg ➤ Subscribe 2015-03-12
➤ Subscribe Extended-release Tablets 25.5 mg and 34 mg ➤ Subscribe 2008-11-28
➤ Subscribe Extended-release Tablets 8.5 mg and 17 mg ➤ Subscribe 2009-03-02
➤ Subscribe Extended-release Tablets 100 mg and 200 mg ➤ Subscribe 2006-07-20
➤ 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
0984957 2012/048 Ireland ⤷  Start Trial PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1718641 132012902056823 Italy ⤷  Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207
1412357 SPC/GB07/046 United Kingdom ⤷  Start Trial PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323
2316456 1790064-8 Sweden ⤷  Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
1412357 PA2008013,C1412357 Lithuania ⤷  Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1507558 C300528 Netherlands ⤷  Start Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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