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 Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | AB | RX | Yes | Yes | 9,675,613 | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558-004 | Jun 9, 2004 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 090387-001 | Jul 15, 2010 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 074749-001 | Jan 30, 1998 | AA | 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 | 5,362,755 | ⤷ Try a Trial |
| Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 6,451,289 | ⤷ Try a Trial |
| Hikma | REGLAN | metoclopramide hydrochloride | INJECTABLE;INJECTION | 017862-001 | Approved Prior to Jan 1, 1982 | 4,536,386 | ⤷ Try a Trial |
| Hikma | FACTREL | gonadorelin hydrochloride | INJECTABLE;INJECTION | 018123-003 | Sep 30, 1982 | 3,947,569 | ⤷ 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 |
|---|---|---|
| Canada | 3033897 | ⤷ Try a Trial |
| Japan | 7455157 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2016009067 | ⤷ Try a Trial |
| Japan | 2017132791 | ⤷ 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 |
|---|---|---|---|---|
| 1534313 | CR 2015 00072 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| 2465580 | SPC/GB21/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
| 0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
| 2158901 | 122018000044 | Germany | ⤷ Try a Trial | PRODUCT NAME: AZTREONAMIYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| >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.
