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Last Updated: April 18, 2021

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Hikma Company Profile

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What is the competitive landscape for HIKMA, and when can generic versions of HIKMA drugs launch?

HIKMA has three hundred and fifty-three approved drugs.

There are five US patents protecting HIKMA drugs. There are three tentative approvals on HIKMA drugs.

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 088088-001 Nov 2, 1987 AB RX No No   Start Trial   Start Trial
Hikma ICOSAPENT ETHYL icosapent ethyl CAPSULE;ORAL 209457-001 May 21, 2020 AB RX No No   Start Trial   Start Trial
Hikma IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 091099-002 Apr 16, 2010 AB RX No No   Start Trial   Start Trial
Hikma ETOMIDATE etomidate INJECTABLE;INJECTION 202354-001 Feb 25, 2016 AP RX No No   Start Trial   Start Trial
Hikma LEVOMILNACIPRAN HYDROCHLORIDE levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210732-004 Nov 5, 2020 AB RX No No   Start Trial   Start Trial
Hikma SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 089049-001 Nov 17, 1986 DISCN No No   Start Trial   Start Trial
Hikma Farmaceutica GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 090963-001 Sep 21, 2011 AP RX No Yes   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for HIKMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Capsules 0.6 mg ➤ Subscribe 2016-06-10
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Tablets 1 mg ➤ Subscribe 2009-08-14
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
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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