Hikma Company Profile

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HIKMA has five hundred and sixty-seven approved drugs.

There are nine US patents protecting HIKMA drugs. There are four tentative approvals on HIKMA drugs.

There are fourteen patent family members on HIKMA drugs in seven countries and five hundred and thirty-six supplementary protection certificates in seventeen countries.

International Patents:	14
US Patents:	9
Tradenames:	357
Ingredients:	320
NDAs:	567
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	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	022195-003	Jan 25, 2010	AA	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Hikma Intl Pharms	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	022276-002	Apr 7, 2016		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Hikma Intl Pharms	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040836-002	Mar 5, 2009		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	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	4,017,616	⤷ Try a Trial
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-004	May 28, 1987	4,536,386	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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	Tablets	1 mg	➤ Subscribe	2009-08-14
➤ 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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	132018000000341	Italy	⤷ Try a Trial	PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
0240228	2000C/015	Belgium	⤷ Try a Trial	PRODUCT NAME: QUETIAPINE FUMARAT (EQUIV. MET 25MG QUETIAPINE BASE); REGISTRATION NO/DATE: 624 S 309 F 3 20000207; FIRST REGISTRATION: GB PL 12619/0113 19970731
1380301	2009C/007	Belgium	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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