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Generated: July 22, 2017
What is the competitive landscape for HORIZON PHARMA, and what generic alternatives to HORIZON PHARMA drugs are available?
HORIZON PHARMA has eight approved drugs.| Patents: | 52 |
| Tradenames: | 7 |
| Ingredients: | 7 |
| NDAs: | 8 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Horizon Pharma | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | AB | RX | Yes | No | 9,040,085 | ► Subscribe | ► Subscribe | |||||||||||||||||
Horizon Pharma | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | 9,192,590 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | AB | RX | Yes | No | 8,852,636 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | AB | RX | Yes | Yes | 5,900,424*PED | ► Subscribe | ► Subscribe | |||||||||||||||||
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| 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 | 6,875,872*PED | ► Subscribe | ||||||||||||||||||||||
Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | 6,875,872*PED | ► Subscribe | ||||||||||||||||||||||
Horizon Pharma Inc | BUPHENYL | sodium phenylbutyrate | TABLET;ORAL | 020572-001 | May 13, 1996 | 4,457,942 | ► Subscribe | ||||||||||||||||||||||
Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | 5,900,424*PED | ► Subscribe | ||||||||||||||||||||||
Horizon Pharma Usa | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | 5,714,504*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
diclofenac sodium | Topical Solution | 2.0% | PENNSAID | 6/3/2014 |
prednisone | Delayed-release Tablets | 1 mg, 2 mg, and 5 mg | RAYOS | 11/26/2012 |
diclofenac sodium | Topical Solution | 1.5% | PENNSAID | 7/11/2012 |
ibuprofen and famotidine | Tablets | 800 mg/26.6 mg | DUEXIS | 12/6/2011 |
naproxen and esomeprazole magnesium | Delayed-release Tablet | 375 mg/20 mg and 500 mg/20 mg | VIMOVO | 11/5/2010 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,206,741 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ► Subscribe | |||||||||||||||||||||||||||
| 8,865,190 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ► Subscribe | |||||||||||||||||||||||||||
| 9,511,039 | Enterically coated cysteamine, cystamine and derivatives thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,920,838 | Delayed-release glucocorticoid treatment of rheumatoid disease | ► Subscribe | |||||||||||||||||||||||||||
| 6,677,455 | Potassium salt of S-omeprazole | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | PI0714937 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2008049020 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2010151216 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60237087 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 2774 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB98/030 | United Kingdom | ► Subscribe | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 | ||||||||||||||||||||||||||
| 5 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 666 | Luxembourg | ► Subscribe | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 | ||||||||||||||||||||||||||
| C0076 | France | ► Subscribe | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514 | ||||||||||||||||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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