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Generated: July 23, 2017
What is the competitive landscape for MALLINCKRODT INC, and when can generic versions of MALLINCKRODT INC drugs launch?
MALLINCKRODT INC has thirty-one approved drugs.| Patents: | 13 |
| Tradenames: | 27 |
| Ingredients: | 19 |
| NDAs: | 31 |
| Drug Master File Entries: (click here to view) | 137 |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mallinckrodt Inc | RESTORIL | temazepam | CAPSULE;ORAL | 018163-003 | Oct 25, 1991 | 5,326,758 | ► Subscribe | ||||||||||||||||||||||
Mallinckrodt Inc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-002 | Mar 1, 2010 | 5,914,131 | ► Subscribe | ||||||||||||||||||||||
Mallinckrodt Inc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-003 | Mar 1, 2010 | 5,702,725 | ► Subscribe | ||||||||||||||||||||||
Mallinckrodt Inc | PAMELOR | nortriptyline hydrochloride | SOLUTION;ORAL | 018012-001 | Approved Prior to Jan 1, 1982 | 3,922,305 | ► Subscribe | ||||||||||||||||||||||
Mallinckrodt Inc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-003 | Mar 1, 2010 | 5,914,131 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
| 9,629,837 | Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period 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 | |||||||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 102105136 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2009114648 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03035041 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20140021992 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2262484 | ► 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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0653 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 | ||||||||||||||||||||||||||
| C/GB07/011 | United Kingdom | ► Subscribe | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 | ||||||||||||||||||||||||||
| 90018-6 | Sweden | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||||||||||||||||
| 2014000024 | Germany | ► Subscribe | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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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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