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 sixty-three approved drugs.
There are eighteen 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-one supplementary protection certificates in seventeen countries.
Summary for Hikma
| International Patents: | 70 |
| US Patents: | 18 |
| Tradenames: | 420 |
| Ingredients: | 373 |
| NDAs: | 663 |
| 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 | COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320-001 | Oct 17, 2023 | RX | Yes | Yes | 11,389,416 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Hikma Intl Pharms | HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 083365-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Hikma | TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 040337-001 | Feb 16, 2000 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Hikma | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET;ORAL | 074597-001 | Jul 29, 1998 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| >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 | 020837-004 | Jul 18, 2003 | 6,083,993 | ⤷ Subscribe |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 5,844,002 | ⤷ Subscribe |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 3,947,569 | ⤷ Subscribe |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,362,755 | ⤷ Subscribe |
| >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 | 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 |
International Patents for Hikma Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3656377 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2016009067 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2017013591 | ⤷ Subscribe |
| Cyprus | 1122899 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Hikma Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2785706 | 122020000046 | Germany | ⤷ Subscribe | PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316 |
| 0503785 | C300375 | Netherlands | ⤷ Subscribe | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 |
| 0733366 | SPC/GB98/031 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 |
| 0502314 | SPC/GB11/010 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
| >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.
