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-two approved drugs.
There are sixteen US patents protecting HIKMA drugs. There are five tentative approvals on HIKMA drugs.
There are sixty-nine patent family members on HIKMA drugs in thirty-one countries and five hundred and ninety-nine supplementary protection certificates in seventeen countries.
Summary for Hikma
International Patents: | 69 |
US Patents: | 16 |
Tradenames: | 407 |
Ingredients: | 363 |
NDAs: | 642 |
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 | VANCOLED | vancomycin hydrochloride | INJECTABLE;INJECTION | 062682-004 | May 11, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Hikma | PREDNISONE INTENSOL | prednisone | SOLUTION;ORAL | 088810-001 | Feb 20, 1985 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Hikma | GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 075890-003 | Jul 31, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Hikma | NARATRIPTAN | naratriptan hydrochloride | TABLET;ORAL | 090381-001 | Jul 7, 2010 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 206263-001 | Jun 16, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Hikma | TORSEMIDE | torsemide | TABLET;ORAL | 076943-003 | Mar 1, 2005 | AB | 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 | 020837-004 | Jul 18, 2003 | 6,083,993 | ⤷ Try a Trial |
Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 4,110,438 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 5,362,755 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 6,083,993 | ⤷ Try a Trial |
Hikma | ATIVAN | lorazepam | INJECTABLE;INJECTION | 018140-001 | Approved Prior to Jan 1, 1982 | 4,017,616 | ⤷ Try a Trial |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,760,090 | ⤷ 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 | 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 |
➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
International Patents for Hikma Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 113018258 | ⤷ Try a Trial |
Singapore | 11201700421R | ⤷ Try a Trial |
Serbia | 59258 | ⤷ Try a Trial |
Portugal | 2635269 | ⤷ Try a Trial |
Slovenia | 3169307 | ⤷ Try a Trial |
European Patent Office | 3500261 | ⤷ 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 |
---|---|---|---|---|
2957286 | 300962 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721 |
2443246 | 132021000000156 | Italy | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329 |
1744764 | 18C1047 | France | ⤷ Try a Trial | PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
1746976 | 2017/029 | Ireland | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014 |
2435025 | LUC00124 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
0303507 | 97C0102 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.