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Akorn Company Profile

AKORN has two hundred and fifty-three approved drugs.

There are four US patents protecting AKORN drugs. There are two tentative approvals on AKORN drugs.

There are seventy patent family members on AKORN drugs in thirty-one countries and two hundred and fifty-six supplementary protection certificates in fifteen countries.

International Patents:	70
US Patents:	4
Tradenames:	187
Ingredients:	167
NDAs:	253
Patent Litigation for Akorn:	See patent lawsuits for Akorn
PTAB Cases with Akorn as petitioner:	See PTAB cases with Akorn as petitioner

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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

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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

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

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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

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