HIKMA Company Profile
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What is the competitive landscape for HIKMA, and what generic alternatives to HIKMA drugs are available?
HIKMA has six hundred and sixty-two approved drugs.
There are seventeen US patents protecting HIKMA drugs. There are five tentative approvals on HIKMA drugs.
There are seventy patent family members on HIKMA drugs in thirty-one countries and six hundred and twenty supplementary protection certificates in seventeen countries.
Summary for HIKMA
International Patents: | 70 |
US Patents: | 17 |
Tradenames: | 420 |
Ingredients: | 373 |
NDAs: | 662 |
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 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 203326-002 | Jun 27, 2014 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | PREDNISONE INTENSOL | prednisone | SOLUTION;ORAL | 088810-001 | Feb 20, 1985 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
Hikma | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 213175-003 | Mar 7, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075222-002 | Apr 26, 1999 | 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 | 020837-001 | Mar 25, 1999 | 5,760,090 | ⤷ Sign Up |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | 6,451,289 | ⤷ Sign Up |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | 5,362,755 | ⤷ 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 | 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 |
➤ 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 |
International Patents for HIKMA Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Philippines | 12021550804 | ⤷ Sign Up |
Japan | 6745798 | ⤷ Sign Up |
Poland | 3169307 | ⤷ Sign Up |
Eurasian Patent Organization | 036212 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HIKMA Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2022495 | C202130051 | Spain | ⤷ Sign Up | PRODUCT NAME: ICOSAPENTO DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1524; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1524; DATE OF FIRST AUTHORISATION IN EEA: 20210326 |
0509752 | 49/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306 |
1280520 | 122015000021 | Germany | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
2782584 | 2021C/558 | Belgium | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.