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Last Updated: January 21, 2021

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Akorn Company Profile

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Summary for Akorn

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 GENTAMICIN SULFATE gentamicin sulfate OINTMENT;OPHTHALMIC 064093-001 Aug 31, 1995 AT RX No Yes   Start Trial   Start Trial
Akorn OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 213757-001 Aug 19, 2020 AB RX No No   Start Trial   Start Trial
Akorn AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040165-001 Jan 13, 1997 DISCN No No   Start Trial   Start Trial
Akorn Inc CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 203048-003 Apr 4, 2013 AP RX No No   Start Trial   Start Trial
Akorn DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 209484-001 Nov 21, 2018 AB RX No No   Start Trial   Start Trial
Akorn KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078434-001 Nov 5, 2009 AT 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 020837-004 Jul 18, 2003 6,083,993   Start Trial
Akorn AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007 6,239,113   Start Trial
Akorn COSOPT dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 020869-001 Apr 7, 1998 4,619,939*PED   Start Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 6,083,993   Start Trial
Akorn ALFENTA alfentanil hydrochloride INJECTABLE;INJECTION 019353-001 Dec 29, 1986 4,167,574   Start Trial
Akorn XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 5,547,994   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 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
➤ 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

Supplementary Protection Certificates for Akorn Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1912999 14C0076 France   Start Trial PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1534313 C 2015 055 Romania   Start Trial PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728
0480717 SPC/GB98/025 United Kingdom   Start Trial PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
0162036 C300028 Netherlands   Start Trial PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0660716 02C0033 France   Start Trial PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
1685839 92292 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>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:

Express Scripts
AstraZeneca
Moodys
Medtronic
Colorcon
Johnson and Johnson

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