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Last Updated: March 19, 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 VANCOLED vancomycin hydrochloride INJECTABLE;INJECTION 062682-004 May 11, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma PREDNISONE INTENSOL prednisone SOLUTION;ORAL 088810-001 Feb 20, 1985 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Hikma GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890-003 Jul 31, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090381-001 Jul 7, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Hikma LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206263-001 Jun 16, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Hikma TORSEMIDE torsemide TABLET;ORAL 076943-003 Mar 1, 2005 AB 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 020837-004 Jul 18, 2003 6,083,993 ⤷  Try a Trial
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-003 Sep 30, 1982 4,110,438 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 5,362,755 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 6,083,993 ⤷  Try a Trial
Hikma ATIVAN lorazepam INJECTABLE;INJECTION 018140-001 Approved Prior to Jan 1, 1982 4,017,616 ⤷  Try a Trial
Hikma XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 5,760,090 ⤷  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
2957286 300962 Netherlands ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2443246 132021000000156 Italy ⤷  Try a Trial PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329
1744764 18C1047 France ⤷  Try a Trial PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1746976 2017/029 Ireland ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
2435025 LUC00124 Luxembourg ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
0303507 97C0102 Belgium ⤷  Try a Trial PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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