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Last Updated: July 18, 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 RIFAMPIN rifampin CAPSULE;ORAL 065028-001 Mar 14, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up
Hikma Pharms BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 205141-002 Feb 11, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up
Hikma MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 211452-003 Jan 12, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up
Hikma Pharms PREDNISONE prednisone TABLET;ORAL 040538-001 Jan 8, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 AB RX Yes Yes 8,927,607 ⤷  Sign Up ⤷  Sign Up
Hikma DEXAMETHASONE INTENSOL dexamethasone CONCENTRATE;ORAL 088252-001 Sep 1, 1983 RX No Yes ⤷  Sign Up ⤷  Sign Up
>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 5,547,994 ⤷  Sign Up
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 5,760,090 ⤷  Sign Up
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 5,362,755 ⤷  Sign Up
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-002 Sep 30, 1982 3,947,569 ⤷  Sign Up
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 6,451,289 ⤷  Sign Up
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-002 Sep 30, 1982 4,110,438 ⤷  Sign Up
>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 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
➤ 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

Supplementary Protection Certificates for HIKMA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303507 64/1997 Austria ⤷  Sign Up PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
2269603 300769 Netherlands ⤷  Sign Up PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725
0413455 98C0040 Belgium ⤷  Sign Up PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
1304992 92401 Luxembourg ⤷  Sign Up PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
2203431 CR 2015 00014 Denmark ⤷  Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1189916 CA 2011 00005 Denmark ⤷  Sign Up PRODUCT NAME: REGADENOSON OG SALTE DERAF
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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