HIKMA Company Profile

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HIKMA has six hundred and sixty-three approved drugs.

There are eighteen 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 twenty-one supplementary protection certificates in seventeen countries.

International Patents:	70
US Patents:	18
Tradenames:	420
Ingredients:	373
NDAs:	663
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 Farmaceutica	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065238-001	Mar 12, 2010	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Hikma Pharms	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065191-001	Jan 25, 2005	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
Hikma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065413-001	Jul 29, 2008	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
>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	020837-004	Jul 18, 2003	6,083,993	⤷ Subscribe
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,844,002	⤷ Subscribe
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	3,947,569	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Estimated Expiration
Mexico	2017000764	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2016008546	⤷ Subscribe
Russian Federation	2707089	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	C300154	Netherlands	⤷ Subscribe	PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
2317997	2190050-1	Sweden	⤷ Subscribe	PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
2768484	1990053-9	Sweden	⤷ Subscribe	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.