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Horizon Pharma Company Profile
What is the competitive landscape for HORIZON PHARMA, and what generic alternatives to HORIZON PHARMA drugs are available?
There are fifty-five US patents protecting HORIZON PHARMA drugs.
There are two hundred and fifty-two patent family members on HORIZON PHARMA drugs in fifty-two countries and sixty-three supplementary protection certificates in fourteen countries.
Summary for Horizon Pharma
| International Patents: | 252 |
| US Patents: | 55 |
| Tradenames: | 7 |
| Ingredients: | 7 |
| NDAs: | 8 |
| Patent Litigation for Horizon Pharma: | See patent lawsuits for Horizon Pharma |
Drugs and US Patents for Horizon Pharma
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | |||||
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | 9,198,888 | ➤ Sign Up | ➤ Sign Up | |||
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | AB | RX | Yes | No | 8,557,285 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | 9,220,698 | ➤ Sign Up | ➤ Sign Up | |||
| 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 Horizon Pharma
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | 5,900,424*PED | ➤ Sign Up |
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | 5,714,504*PED | ➤ Sign Up |
| Horizon Pharma Inc | BUPHENYL | sodium phenylbutyrate | POWDER;ORAL | 020573-001 | Apr 30, 1996 | 4,457,942 | ➤ Sign Up |
| Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | 6,875,872*PED | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for HORIZON PHARMA drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablet | 375 mg/20 mg and 500 mg/20 mg | ➤ Subscribe | 2010-11-05 |
| ➤ Subscribe | Topical Solution | 1.5% | ➤ Subscribe | 2012-07-11 |
| ➤ Subscribe | Topical Solution | 2.0% | ➤ Subscribe | 2014-06-03 |
| ➤ Subscribe | Tablets | 800 mg/26.6 mg | ➤ Subscribe | 2011-12-06 |
| ➤ Subscribe | Delayed-release Tablets | 1 mg, 2 mg, and 5 mg | ➤ Subscribe | 2012-11-26 |
Non-Orange Book US Patents for Horizon Pharma
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,364,439 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ➤ Sign Up |
| 8,076,361 | Form of S-omeprazole | ➤ Sign Up |
| 6,677,455 | Potassium salt of S-omeprazole | ➤ Sign Up |
| 8,129,433 | Enterically coated cysteamine, cystamine and derivatives thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Horizon Pharma Drugs
Supplementary Protection Certificates for Horizon Pharma Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 15/009 | Ireland | ➤ Sign Up | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| 99C0030 | Belgium | ➤ Sign Up | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
| C/GB97/078 | United Kingdom | ➤ Sign Up | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
| 2014 00013 | Denmark | ➤ Sign Up | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906 |
| 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.
