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	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319-001	Jun 30, 1992	AB	RX	No	Yes
Hikma Intl Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	206617-002	Jun 25, 2021	AP	RX	No	No
Hikma	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	208817-001	Aug 10, 2017	AA	RX	No	No
Hikma Farmaceutica	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	200300-001	Jan 26, 2011	AP	RX	No	No
Hikma	INFUMORPH	morphine sulfate	INJECTABLE;INJECTION	018565-004	Jul 19, 1991	AP	RX	Yes	Yes
Hikma	IMMPHENTIV	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	203826-005	Mar 9, 2023		RX	Yes	Yes	11,471,400		Y

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	5,362,755
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	6,451,289
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982	4,536,386
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569
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	5,547,994

Paragraph IV (Patent) Challenges for HIKMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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
Japan	2019528278
Russian Federation	2015103107
Canada	2955557
Brazil	112017001093
Mexico	2013005113
European Patent Office	3177146

Supplementary Protection Certificates for Hikma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2768484	C201930069	Spain		PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0719278	SPC/GB03/018	United Kingdom		PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
0509752	2000C/001	Belgium		PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306

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