Hikma Company Profile

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HIKMA has five hundred and forty approved drugs.

There are eight US patents protecting HIKMA drugs.

There are eleven patent family members on HIKMA drugs in seven countries and five hundred and five supplementary protection certificates in seventeen countries.

International Patents:	11
US Patents:	8
Tradenames:	339
Ingredients:	303
NDAs:	540
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	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	202691-002	Feb 16, 2016	AP	RX	No	No		See Plans and Pricing				See Plans and Pricing
Hikma	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	labetalol hydrochloride	SOLUTION;INTRAVENOUS	213330-003	Nov 9, 2020		RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Hikma	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017037-013	Apr 7, 1986		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
>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	018123-003	Sep 30, 1982	3,947,569	See Plans and Pricing
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	3,947,569	See Plans and Pricing
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	4,017,616	See Plans and Pricing
>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	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ 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
1874117	2014/032	Ireland	See Plans and Pricing	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1827461	300930	Netherlands	See Plans and Pricing	PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
0480717	19/1999	Austria	See Plans and Pricing	PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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