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Last Updated: April 7, 2020

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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 thirty-five approved drugs.

There are five US patents protecting HIKMA drugs. There are two 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 CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591-001 Jul 8, 2013 AB RX No No   Start Trial   Start Trial
Hikma THIOTHIXENE HYDROCHLORIDE INTENSOL thiothixene hydrochloride CONCENTRATE;ORAL 073494-001 Jun 30, 1992 DISCN No No   Start Trial   Start Trial
Hikma INFUMORPH morphine sulfate INJECTABLE;INJECTION 018565-003 Jul 19, 1991 AP RX Yes Yes   Start Trial   Start Trial
Hikma CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558-004 Jun 9, 2004 AB RX No No   Start Trial   Start Trial
Hikma Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 077864-003 Aug 10, 2009 DISCN No No   Start Trial   Start Trial
Hikma Intl Pharms AMINOPHYLLINE aminophylline TABLET;ORAL 084540-001 Approved Prior to Jan 1, 1982 DISCN No No   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 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
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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