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 one 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 Pharms	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	205141-001	Feb 11, 2021	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	205758-001	May 21, 2015	AP	RX	No	Yes		⤷ Try a Trial				⤷ Try a Trial
Hikma	CIMETIDINE	cimetidine	TABLET;ORAL	074890-004	Dec 18, 1998		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	083862-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075812-001	Jun 15, 2001	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062879-002	Aug 2, 1988		DISCN	No	No		⤷ 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	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569	⤷ Try a Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	4,110,438	⤷ Try a Trial
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,362,755	⤷ Try a Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	3,947,569	⤷ Try a Trial
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,547,994	⤷ Try a Trial
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,362,755	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2269603	92880	Luxembourg	⤷ Try a Trial	PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (AFINITOR); AUTHORISATION NUMBER AND DATE: EU/1/09/538/001,003,004 ET 006-010 - AFINITOR
1507558	C300528	Netherlands	⤷ Try a Trial	PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
1429780	122012000070	Germany	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
2768484	19C1063	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
0564409	C00564409/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
1411900	18/2011	Austria	⤷ Try a Trial	PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.