Hikma Company Profile

« Back to Dashboard

What is the competitive landscape for HIKMA

HIKMA has six hundred and eighty-one approved drugs.

There are thirty-four US patents protecting HIKMA drugs. There are six tentative approvals on HIKMA drugs.

Summary for Hikma

US Patents:	34
Tradenames:	443
Ingredients:	396
NDAs:	681
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	SODIUM POLYSTYRENE SULFONATE	sodium polystyrene sulfonate	SUSPENSION;ORAL, RECTAL	089049-001	Nov 17, 1986		DISCN	No	No
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063315-001	Apr 11, 1994	AP	RX	No	No
Hikma	ESZOPICLONE	eszopiclone	TABLET;ORAL	091153-001	Apr 15, 2014		DISCN	No	No
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-007	May 13, 2020		RX	Yes	Yes	11,517,609

Expired US Patents for Hikma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	5,547,994
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,362,755
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,760,090

Paragraph IV (Patent) Challenges for HIKMA drugs

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

International Patents for Hikma Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3500261
Japan	7032488
Slovenia	3215173
Philippines	12017500720

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	1990034-9	Sweden		PRODUCT NAME: A COMBINATION OF GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALT OR ESTERS THEREOF AND FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS OR ESTERS THEREOF.; REG. NO/DATE: EU/1/18/1339 20181220
1115417	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
2822954	2018/031	Ireland		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1020454	10C0022	France		PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421

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