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Last Updated: April 24, 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 ESMOLOL HYDROCHLORIDE esmolol hydrochloride INJECTABLE;INJECTION 076323-001 Aug 10, 2004 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Hikma LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 077732-002 Oct 6, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL 213561-001 Dec 1, 2021 AP RX 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 020837-002 Mar 25, 1999 5,362,755 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 6,451,289 ⤷  Try a Trial
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982 4,536,386 ⤷  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
0296560 2/1998 Austria ⤷  Try a Trial PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
1856135 CR 2020 00018 Denmark ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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