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 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 Farmaceutica | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078698-001 | Jan 30, 2012 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202827-006 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | ACETAZOLAMIDE SODIUM | acetazolamide sodium | INJECTABLE;INJECTION | 040089-001 | Feb 28, 1995 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | RIFAMPIN | rifampin | INJECTABLE;INJECTION | 064217-001 | Oct 29, 1999 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma Pharms | GLIMEPIRIDE | glimepiride | TABLET;ORAL | 078952-003 | Aug 1, 2013 | DISCN | 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 | 020837-003 | Jan 30, 2002 | 5,760,090 | ⤷ Try a Trial |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-002 | Sep 30, 1982 | 3,947,569 | ⤷ Try a Trial |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 6,451,289 | ⤷ Try a Trial |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 6,083,993 | ⤷ Try a Trial |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 6,083,993 | ⤷ 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 | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ 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 |
International Patents for Hikma Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E045442 | ⤷ Try a Trial |
| China | 107519159 | ⤷ Try a Trial |
| Australia | 2011324137 | ⤷ Try a Trial |
| Spain | 2742373 | ⤷ Try a Trial |
| Poland | 2635269 | ⤷ 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 |
|---|---|---|---|---|
| 0473687 | 3/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204 |
| 0503785 | CA 2011 00026 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
| 1849470 | 2017/033 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425 |
| 2435025 | 19C1040 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220 |
| 1519731 | 132013902182575 | Italy | ⤷ Try a Trial | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
| >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.
