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Akorn Company Profile

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What is the competitive landscape for AKORN, and what generic alternatives to AKORN drugs are available?

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.

Summary for Akorn

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

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	AKPENTOLATE	cyclopentolate hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040164-001	Jan 13, 1997	AT	RX	No	No
Akorn	DESONIDE	desonide	OINTMENT;TOPICAL	208836-001	Mar 27, 2017	AB	RX	No	No
Akorn Inc	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	201422-001	May 28, 2014	AN	RX	No	No
Akorn	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes
Akorn	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	209484-001	Nov 21, 2018	AB	RX	No	No

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
Akorn	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,547,994
Akorn	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	4,797,413*PED
Akorn	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002	5,547,994
Akorn	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995	5,231,095

Paragraph IV (Patent) Challenges for AKORN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Ophthalmic Solution	2%/0.5%		2005-10-11
	Inhalation Solution	0.0103%, 0.021% and 0.042%		2005-06-20
	Inhalation Aerosol	0.045 mg/actuation		2012-02-27
	Ophthalmic Solution	1%		2011-03-03
	Ophthalmic Solution	0.0015%		2016-02-10
	Inhalation Solution	0.0025		2006-05-23

International Patents for Akorn Drugs

Country	Patent Number	Estimated Expiration
Luxembourg	91943
South Korea	101820816
Japan	6356868
China	1187486
Eurasian Patent Organization	201071413

Supplementary Protection Certificates for Akorn Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0477295	C990043	Netherlands		PRODUCT NAME: EPTIFIBATIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 - EU/1/99/109/002 19990701; FIRST REGISTRATION: CH 54050, 54054 19970227
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1429780	13C0012	France		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
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
2114383	CR 2016 00007	Denmark		PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Akorn
• Akorn Inc
• Akorn Mfg