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 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: | 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 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 213667-001 | Dec 18, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | METHADONE HYDROCHLORIDE INTENSOL | methadone hydrochloride | CONCENTRATE;ORAL | 089897-001 | Sep 6, 1988 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 040675-001 | Dec 23, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Hikma | INFUMORPH | morphine sulfate | INJECTABLE;INJECTION | 018565-003 | Jul 19, 1991 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723-002 | Apr 21, 2020 | AO | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% | fluconazole | INJECTABLE;INJECTION | 076087-003 | Jul 29, 2004 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 203826-001 | Dec 20, 2012 | AP2 | RX | Yes | Yes | ⤷ 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 | 6,451,289 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,760,090 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,547,994 | ⤷ Sign Up |
| Hikma | ATIVAN | lorazepam | INJECTABLE;INJECTION | 018140-001 | Approved Prior to Jan 1, 1982 | 4,017,616 | ⤷ Sign Up |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 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 | 5,547,994 | ⤷ 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 |
|---|---|---|---|---|
| 0933372 | 13/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713 |
| 0637297 | 01C0027 | France | ⤷ Sign Up | PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329 |
| 1353647 | 2011/024 | Ireland | ⤷ Sign Up | PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923 |
| 0454511 | SPC/GB99/008 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
| 0717738 | SPC/GB01/025 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105 |
| 2435024 | 2021C/518 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
| 0663916 | C00663916/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005 |
| >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.
