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Last Updated: March 28, 2024

HIKMA Company Profile


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Summary for HIKMA

Drugs and US Patents for HIKMA

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 ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086067-001 Oct 29, 1987 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Hikma NALOXONE naloxone hydrochloride INJECTABLE;INJECTION 070298-001 Sep 24, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 076246-002 Jul 29, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078656-001 May 24, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083567-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065289-001 Jun 27, 2007 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Hikma CHLOROTHIAZIDE AND RESERPINE chlorothiazide; reserpine TABLET;ORAL 088557-001 Dec 22, 1983 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

Expired US Patents for HIKMA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 6,451,289 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 6,451,289 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 6,083,993 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 5,547,994 ⤷  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
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
Paragraph IV (Patent) Challenges for HIKMA drugs
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

Supplementary Protection Certificates for HIKMA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269604 93320 Luxembourg ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
0502314 C300095 Netherlands ⤷  Try a Trial PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0521471 C300125 Netherlands ⤷  Try a Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
2782584 C202130068 Spain ⤷  Try a Trial PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
1539166 2013C/064 Belgium ⤷  Try a Trial PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
0166287 96C0032 Belgium ⤷  Try a Trial PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
2236132 C300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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