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 | DICYCLOMINE HYDROCHLORIDE | dicyclomine hydrochloride | INJECTABLE;INJECTION | 210788-001 | Feb 11, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Hikma | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 089341-001 | Sep 16, 1986 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 065410-001 | Jul 29, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | METRONIDAZOLE | metronidazole | INJECTABLE;INJECTION | 018907-001 | Mar 30, 1984 | 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 |
>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 | 0.0103%, 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 |
➤ 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 |
International Patents for HIKMA Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Argentina | 100365 | ⤷ Try a Trial |
China | 107519159 | ⤷ Try a Trial |
China | 113018258 | ⤷ Try a Trial |
Japan | 2017519803 | ⤷ 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 |
---|---|---|---|---|
0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
2203431 | 2015/009 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
0275821 | SPC/GB01/039 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128 |
0383579 | SPC/GB96/059 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: REMIFENTANIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT, INCLUDING REMIFENTANIL HYDROCHLORIDE; REGISTERED: DE 36335.00.00 19960517; DE 36335.01.00 19960517; DE 36335.02.00 19960517; UK 14213/0002 19961030; UK 14213/0003 19961030; UK 14213/0004 19961030 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.