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-seven 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 five supplementary protection certificates in seventeen countries.
Summary for Hikma
International Patents: | 70 |
US Patents: | 17 |
Tradenames: | 410 |
Ingredients: | 365 |
NDAs: | 647 |
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 | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065074-001 | Mar 19, 2002 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 203078-001 | Jun 28, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064117-003 | Jun 2, 1999 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202827-001 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma Farmaceutica | PROGESTERONE | progesterone | INJECTABLE;INJECTION | 091033-001 | Oct 28, 2010 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 217034-001 | May 24, 2023 | AP | 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 | 5,547,994 | ⤷ Try a Trial |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 3,947,569 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | 5,760,090 | ⤷ Try a Trial |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-001 | Sep 30, 1982 | 3,947,569 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 5,760,090 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,844,002 | ⤷ 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 | 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 |
➤ Subscribe | Tablets | 1 mg | ➤ Subscribe | 2009-08-14 |
International Patents for Hikma Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2015103107 | ⤷ Try a Trial |
Colombia | 6771406 | ⤷ Try a Trial |
South Korea | 20140025314 | ⤷ Try a Trial |
Chile | 2013001250 | ⤷ Try a Trial |
China | 106794163 | ⤷ Try a Trial |
Russian Federation | 2013123646 | ⤷ 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 |
---|---|---|---|---|
1020454 | 19/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
0809498 | SPC/GB10/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
0994863 | 07C0037 | France | ⤷ Try a Trial | PRODUCT NAME: MODIFICATION CRISTALLINE A DU RUFINAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/378/001 DU 20070116; REGISTRATION NO/DATE AT EEC: EU/1/06/378/001-016 DU 20070116 |
0300652 | C300117 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830 |
1744764 | 122018000134 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZUSAMMENSETZUNG AUS DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823 |
0258618 | SPC/GB01/042 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.