Hikma Company Profile

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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.

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	CORTISONE ACETATE	cortisone acetate	TABLET;ORAL	080776-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	040151-001	Aug 26, 1997	AA	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma Farmaceutica	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	INJECTABLE;INJECTION	202651-001	Aug 9, 2012	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064117-003	Jun 2, 1999	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	019101-001	Jul 11, 1984	AP	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Hikma Farmaceutica	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078527-002	Mar 23, 2009	AP	RX	No	Yes		⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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	⤷ Try a Trial
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	6,451,289	⤷ Try a Trial
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982	4,536,386	⤷ Try a Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569	⤷ Try a Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569	⤷ Try a Trial
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,547,994	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018034920	⤷ Try a Trial
Singapore	11201700421R	⤷ Try a Trial
Japan	2022119843	⤷ Try a Trial
Poland	2635269	⤷ Try a Trial
Argentina	100365	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2016008546	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0994864	SPC/GB07/041	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0526708	02C0042	France	⤷ Try a Trial	PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
2203431	1590018-6	Sweden	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0287150	96C0038	Belgium	⤷ Try a Trial	PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
2269604	122016000094	Germany	⤷ Try a Trial	PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
0633893	2012/003	Ireland	⤷ Try a Trial	PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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