Hikma Company Profile
✉ Email this page to a colleague
What is the competitive landscape for HIKMA, and when can generic versions of HIKMA drugs launch?
HIKMA has six hundred and fifty approved drugs.
There are seventeen US patents protecting HIKMA drugs. There are four tentative approvals on HIKMA drugs.
There are seventy patent family members on HIKMA drugs in thirty-one countries and six hundred and twenty-one supplementary protection certificates in seventeen countries.
Summary for Hikma
| International Patents: | 70 |
| US Patents: | 17 |
| Tradenames: | 413 |
| Ingredients: | 368 |
| NDAs: | 650 |
| Patent Litigation for Hikma: | See patent lawsuits for Hikma |
| PTAB Cases with Hikma as petitioner: | See PTAB cases with Hikma as petitioner |
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 | AMINOPHYLLINE | aminophylline | TABLET;ORAL | 084540-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159-001 | Apr 17, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 077262-003 | Jul 9, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | EVEROLIMUS | everolimus | TABLET;ORAL | 206133-002 | Apr 12, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | DIAZEPAM | diazepam | INJECTABLE;INJECTION | 070312-001 | Dec 16, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 090120-001 | Mar 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | RAMIPRIL | ramipril | CAPSULE;ORAL | 077900-001 | Jun 18, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 020837-002 | Mar 25, 1999 | 5,844,002 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 6,083,993 | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | 4,110,438 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,760,090 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,844,002 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 6,083,993 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,362,755 | ⤷ Sign Up |
| >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 | 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 |
| ➤ 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 |
International Patents for Hikma Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015289035 | ⤷ Sign Up |
| Canada | 2814057 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2012060719 | ⤷ Sign Up |
| Russian Federation | 2707089 | ⤷ Sign Up |
| European Patent Office | 3500261 | ⤷ Sign Up |
| European Patent Office | 3656377 | ⤷ Sign Up |
| Japan | 2017522382 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Hikma Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1746976 | 17C1027 | France | ⤷ Sign Up | PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018 |
| 1304992 | PA2013025,C1304992 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| 0236940 | SPC/GB97/013 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118 |
| 1608344 | LUC00065 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824 |
| 1586316 | C 2011 004 | Romania | ⤷ Sign Up | PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518 |
| 1856135 | 2020/017 | Ireland | ⤷ Sign Up | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
| 0480717 | C990009 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 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.
Here is a list of applicants with similar names.
