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Last Updated: March 5, 2021

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AKORN Company Profile

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Summary for AKORN
International Patents:70
US Patents:4
Tradenames:187
Ingredients:167
NDAs:253
PTAB Cases with AKORN as petitioner: See PTAB cases with AKORN as petitioner

Drugs and US Patents for AKORN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 RX Yes Yes   Start Trial   Start Trial
Akorn TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 202373-001 Nov 17, 2011 AP RX No No   Start Trial   Start Trial
Akorn FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 208024-001 Apr 17, 2019 OTC No No   Start Trial   Start Trial
Akorn AKPRO dipivefrin hydrochloride SOLUTION/DROPS;OPHTHALMIC 074382-001 Sep 29, 1995 DISCN No No   Start Trial   Start Trial
Akorn AMICAR aminocaproic acid TABLET;ORAL 015197-002 Jun 24, 2004 AB RX Yes No   Start Trial   Start Trial
Akorn SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 208635-001 May 4, 2017 AP RX No No   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 AKORN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 5,760,090   Start Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 5,844,002   Start Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 5,362,755   Start Trial
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 7,056,893   Start Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 5,844,002   Start Trial
Akorn ALFENTA alfentanil hydrochloride INJECTABLE;INJECTION 019353-001 Dec 29, 1986 4,167,574   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for AKORN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Inhalation Solution 0.0103%, 0.021% and 0.042% ➤ Subscribe 2005-06-20
➤ Subscribe Inhalation Aerosol 0.045 mg/actuation ➤ Subscribe 2012-02-27
➤ Subscribe Ophthalmic Solution 1% ➤ Subscribe 2011-03-03
➤ Subscribe Ophthalmic Solution 0.0015% ➤ Subscribe 2016-02-10
➤ Subscribe Inhalation Solution 0.0025 ➤ Subscribe 2006-05-23
➤ Subscribe Ophthalmic Solution 2%/0.5% ➤ Subscribe 2005-10-11

Supplementary Protection Certificates for AKORN Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 13C0012 France   Start Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
0137145 SPC/GB97/010 United Kingdom   Start Trial PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
1586316 C 2011 004 Romania   Start Trial PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
2563920 CR 2019 00001 Denmark   Start Trial PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
0850926 SPC/GB09/005 United Kingdom   Start Trial PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
McKinsey
McKesson
Baxter
Colorcon

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