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Generated: October 21, 2017
What is the competitive landscape for MALLINCKRODT INC, and when can generic versions of MALLINCKRODT INC drugs launch?
MALLINCKRODT INC has twenty-nine approved drugs.| International Patents: | 46 |
| US Patents: | 13 |
| Tradenames: | 28 |
| Ingredients: | 19 |
| NDAs: | 29 |
| Drug Master File Entries: (click here to view) | 138 |
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
oxycodone hydrochloride and acetaminophen | Extended-release Tablets | 7.5 mg/325 mg | XARTEMIS XR | 4/3/2014 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,539,328 | Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia | ► Subscribe | |||||||||||||
| 9,198,861 | Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans | ► Subscribe | |||||||||||||
| 8,858,963 | Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia | ► Subscribe | |||||||||||||
| 9,433,582 | Gastric retentive extended release pharmaceutical compositions | ► Subscribe | |||||||||||||
| 9,629,837 | Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia | ► Subscribe | |||||||||||||
| 8,790,694 | Gastric retentive extended release pharmaceutical compositions | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Africa | 201303988 | ► Subscribe | |||||||||||||
| Australia | 3989301 | ► Subscribe | |||||||||||||
| Mexico | 2013007057 | ► Subscribe | |||||||||||||
| Australia | 2001239893 | ► Subscribe | |||||||||||||
| European Patent Office | 1439826 | ► Subscribe | |||||||||||||
| Japan | 2016166239 | ► Subscribe | |||||||||||||
| Japan | 2011513499 | ► Subscribe | |||||||||||||
| Australia | 2011345329 | ► Subscribe | |||||||||||||
| European Patent Office | 2654727 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 03035041 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB08/036 | United Kingdom | ► Subscribe | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 | ||||||||||||
| C0021 | France | ► Subscribe | PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131 | ||||||||||||
| 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 | ||||||||||||
| 00521 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||
| 90020-1 | Sweden | ► Subscribe | PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123 | ||||||||||||
| 14/058 | Ireland | ► Subscribe | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 | ||||||||||||
| C0052 | France | ► Subscribe | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 | ||||||||||||
| C/GB98/030 | United Kingdom | ► Subscribe | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 | ||||||||||||
| C/GB02/042 | United Kingdom | ► Subscribe | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418 | ||||||||||||
| C/GB98/025 | United Kingdom | ► Subscribe | PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115 | ||||||||||||
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Serving leading 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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