Hikma Company Profile
✉ Email this page to a colleague
What is the competitive landscape for HIKMA, and what generic alternatives to HIKMA drugs are available?
HIKMA has six hundred and forty-four approved drugs.
There are sixteen 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 two supplementary protection certificates in seventeen countries.
Summary for Hikma
International Patents: | 70 |
US Patents: | 16 |
Tradenames: | 408 |
Ingredients: | 363 |
NDAs: | 644 |
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 | PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 081319-001 | Jun 30, 1992 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma Intl Pharms | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 206617-002 | Jun 25, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 208817-001 | Aug 10, 2017 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a 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 | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 5,362,755 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 6,451,289 | ⤷ Try a Trial |
Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | 4,536,386 | ⤷ Try a 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 | 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 |
➤ 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 |
International Patents for Hikma Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2019528278 | ⤷ Try a Trial |
Russian Federation | 2015103107 | ⤷ Try a Trial |
Canada | 2955557 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Hikma Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2380576 | SPC/GB20/050 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526 |
1948158 | 16C0018 | France | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
2768484 | C201930069 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.