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-four approved drugs.

There are sixteen 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 two supplementary protection certificates in seventeen countries.

Summary for HIKMA

International Patents:	70
US Patents:	16
Tradenames:	408
Ingredients:	363
NDAs:	644
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	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	203125-002	Sep 26, 2022	AP	RX	No	No
Hikma	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200822-006	Jul 15, 2013		DISCN	No	No
Hikma	KANAMYCIN	kanamycin sulfate	INJECTABLE;INJECTION	062324-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213261-002	Jul 9, 2021	AP	RX	No	No
Hikma Intl Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	076813-001	Jan 7, 2005		DISCN	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	020837-003	Jan 30, 2002	5,760,090
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	3,947,569
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	6,451,289
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	6,083,993
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002	6,083,993

Paragraph IV (Patent) Challenges for HIKMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for HIKMA Drugs

Country	Patent Number	Estimated Expiration
South Korea	101900520
World Intellectual Property Organization (WIPO)	2016008546
European Patent Office	3169307
Slovenia	2635269
Malaysia	160572

Supplementary Protection Certificates for HIKMA Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	2013/038	Ireland		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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
0137145	SPC/GB97/010	United Kingdom		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
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705

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