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Last Updated: May 26, 2022

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 METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 202691-002 Feb 16, 2016 AP RX No No See Plans and Pricing See Plans and Pricing
Hikma LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-003 Nov 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing
Hikma HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 017037-013 Apr 7, 1986 DISCN No No See Plans and Pricing See Plans and Pricing
>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 FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-003 Sep 30, 1982 3,947,569 See Plans and Pricing
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-001 Sep 30, 1982 3,947,569 See Plans and Pricing
Hikma ATIVAN lorazepam INJECTABLE;INJECTION 018140-001 Approved Prior to Jan 1, 1982 4,017,616 See Plans and Pricing
>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 Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Capsules 0.6 mg ➤ Subscribe 2016-06-10
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16

Supplementary Protection Certificates for Hikma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 2014/032 Ireland See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1827461 300930 Netherlands See Plans and Pricing PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
0480717 19/1999 Austria See Plans and Pricing PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Baxter
Medtronic
Harvard Business School
Boehringer Ingelheim

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