Hikma Company Profile

What is the competitive landscape for HIKMA, and when can generic versions of HIKMA drugs launch?

HIKMA has six hundred and forty-seven approved drugs.

There are seventeen US patents protecting HIKMA drugs. There are five tentative approvals on HIKMA drugs.

There are seventy patent family members on HIKMA drugs in thirty-one countries and six hundred and five supplementary protection certificates in seventeen countries.

Summary for Hikma

International Patents:	70
US Patents:	17
Tradenames:	410
Ingredients:	365
NDAs:	647
Patent Litigation for Hikma:	See patent lawsuits for Hikma
PTAB Cases with Hikma as petitioner:	See PTAB cases with Hikma as petitioner

Drugs and US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	NALOXONE	naloxone hydrochloride	INJECTABLE;INJECTION	070298-001	Sep 24, 1986		DISCN	No	No
Hikma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065413-001	Jul 29, 2008	AB	RX	No	No
Hikma	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	200183-001	Sep 16, 2013	AP	RX	No	No
Hikma	IMIPRAMINE PAMOATE	imipramine pamoate	CAPSULE;ORAL	091099-004	Apr 16, 2010	AB	RX	No	No
Hikma	PROTAMINE SULFATE	protamine sulfate	INJECTABLE;INJECTION	089474-001	Nov 5, 1986		DISCN	No	No
Hikma	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	091031-001	Oct 26, 2011		DISCN	No	No
Hikma	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	077541-001	Dec 26, 2006	AP	RX	No	No

Expired US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,547,994
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,760,090
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,760,090
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,844,002
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	4,017,616

Paragraph IV (Patent) Challenges for HIKMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	1 mg		2009-08-14
	Inhalation Solution	0.0025		2006-05-23
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Capsules	0.6 mg		2016-06-10
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Inhalation Solution	0.0103%, 0.021% and 0.042%		2005-06-20
	Inhalation Aerosol	0.045 mg/actuation		2012-02-27
	for Injection	200 mcg/vial		2015-05-01
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24

International Patents for Hikma Drugs

Country	Patent Number	Estimated Expiration
Japan	2013541583
Japan	2019528278
Cyprus	1123398
Mexico	367209
China	113018258
Japan	6353577
Lithuania	2635269

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0347066	10399030	Germany		PRODUCT NAME: ESCITALOPRAMOXALAT; NAT. REGISTRATION NO/DATE: 55880.00.00 55880.01.00 55880.02.00 55880.03.00 55884.00.00 55884.01.00 55884.02.00 55884.03.00 55888.00.00 55888.01.00 55888.02.00 55888.03.00 20030408 FIRST REGISTRATION: SCHWEDEN 17084 17085 17086 17087 20011207
3143995	122019000051	Germany		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
0240228	C980022	Netherlands		PRODUCT NAME: QUETIAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER QUETIAPINEFUMARAAT; NAT. REGISTRATION NO/DATE: RVG 20826 - RVG 20828 19980427; FIRST REGISTRATION: GB PL 12619/0112 - PL 12619/0114 19970731
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1189916	C01189916/01	Switzerland		PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
2269604	62/2016	Austria		PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805

Similar Applicant Names

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

• Hikma
• Hikma Farmaceutica
• Hikma Intl Pharms
• Hikma Pharm Co Ltd
• Hikma Pharms