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Last Updated: August 2, 2021

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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 FAMCICLOVIR famciclovir TABLET;ORAL 090128-002 Mar 21, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203326-001 Jun 27, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma ALENDRONATE SODIUM alendronate sodium SOLUTION;ORAL 090520-001 Feb 25, 2013 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever 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 ATIVAN lorazepam INJECTABLE;INJECTION 018140-001 Approved Prior to Jan 1, 1982 4,017,616 ⤷  Free Forever Trial
Hikma ATIVAN lorazepam INJECTABLE;INJECTION 018140-002 Approved Prior to Jan 1, 1982 4,017,616 ⤷  Free Forever 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 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

Supplementary Protection Certificates for HIKMA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269604 93320 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
1635783 C300653 Netherlands ⤷  Free Forever Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0720599 122014000088 Germany ⤷  Free Forever Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
>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:

McKesson
AstraZeneca
Dow
Merck
Baxter
Express Scripts

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