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 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 | SUFENTANIL CITRATE | sufentanil citrate | INJECTABLE;INJECTION | 074413-001 | Dec 15, 1995 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Farmaceutica | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078764-001 | Jan 30, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 208817-001 | Aug 10, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 078538-001 | Dec 17, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Farmaceutica | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076780-001 | Dec 26, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 214074-003 | Jul 20, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION;TOPICAL | 209896-001 | Feb 6, 2018 | DISCN | 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 | 020837-003 | Jan 30, 2002 | 5,547,994 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,760,090 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | 5,362,755 | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | 3,947,569 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 6,451,289 | ⤷ Sign Up |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | 4,110,438 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,362,555 | ⤷ 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 | Inhalation Solution | 0.0025 | ➤ Subscribe | 2006-05-23 |
| ➤ Subscribe | Inhalation Aerosol | 0.045 mg/actuation | ➤ Subscribe | 2012-02-27 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Tablets | 1 mg | ➤ Subscribe | 2009-08-14 |
| ➤ Subscribe | Inhalation Solution | 0.0103%, 0.021% and 0.042% | ➤ Subscribe | 2005-06-20 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | Capsules | 0.6 mg | ➤ Subscribe | 2016-06-10 |
International Patents for Hikma Drugs
Supplementary Protection Certificates for Hikma Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1853250 | 2014C/037 | Belgium | ⤷ Sign Up | PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230 |
| 2782584 | 122021000080 | Germany | ⤷ Sign Up | PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406 |
| 0770388 | 2009/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
| 2217577 | 1990005-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
| 1534313 | C 2015 055 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA |
| 0994863 | 07C0037 | France | ⤷ Sign Up | PRODUCT NAME: MODIFICATION CRISTALLINE A DU RUFINAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/378/001 DU 20070116; REGISTRATION NO/DATE AT EEC: EU/1/06/378/001-016 DU 20070116 |
| 1758590 | 2017C/063 | Belgium | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612 |
| >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.
