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Generated: October 22, 2017
What is the competitive landscape for ASTELLAS, and what generic alternatives to ASTELLAS drugs are available?
ASTELLAS has thirty-one approved drugs.| International Patents: | 377 |
| US Patents: | 30 |
| Tradenames: | 17 |
| Ingredients: | 13 |
| NDAs: | 31 |
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
enzalutamide | Capsules | 40 mg | XTANDI | 8/31/2016 |
micafungin sodium | For Injection | 50 mg/vial and 100 mg/vial | MYCAMINE | 6/16/2014 |
tacrolimus | Extended-release Capsules | 0.5 mg, 1 mg, and 5 mg | ASTAGRAF XL | 11/15/2013 |
regadenoson | Injection | 0.08 mg/mL, 5 mL vial | LEXISCAN | 4/10/2012 |
solifenacin succinate | Tablets | 5 mg and 10 mg | VESICARE | 4/8/2009 |
adenosine | Injection | 3 mg/mL, 20 mL and 30 mL vials | ADENOSCAN | 4/18/2005 |
adenosine | Injection | 3 mg/mL, 20 mL and 30 mL vials | ADENOSCAN | 4/16/2005 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,524,883 | Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide | ► Subscribe | |||||||||||||
| 8,569,260 | N-pyrazole A.sub.2A receptor agonists | ► Subscribe | |||||||||||||
| 8,071,566 | Methods of coronary imaging | ► Subscribe | |||||||||||||
| 6,770,290 | Amphotericin B liposome preparation | ► Subscribe | |||||||||||||
| 7,112,565 | Stabilized pharmaceutical composition in lyophilized form | ► Subscribe | |||||||||||||
| 8,648,105 | Diarylthiohydantoin compounds | ► Subscribe | |||||||||||||
| 8,268,988 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||
| 7,151,182 | Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives | ► Subscribe | |||||||||||||
| 7,956,179 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||
| 7,671,192 | Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 341071 | ► Subscribe | |||||||||||||
| Germany | 69529844 | ► Subscribe | |||||||||||||
| Japan | 6013535 | ► Subscribe | |||||||||||||
| China | 1167709 | ► Subscribe | |||||||||||||
| China | 101076343 | ► Subscribe | |||||||||||||
| Turkey | 200201205 | ► Subscribe | |||||||||||||
| Japan | 2005538190 | ► Subscribe | |||||||||||||
| Serbia | 53967 | ► Subscribe | |||||||||||||
| South Africa | 200004963 | ► Subscribe | |||||||||||||
| China | 1171109 | ► 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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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013029,C1893196 | Lithuania | ► Subscribe | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625 | ||||||||||||
| 338 | Luxembourg | ► Subscribe | PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625 | ||||||||||||
| C004/2011 | Ireland | ► Subscribe | SPC004/2011: 20110719, EXPIRES: 20250620 | ||||||||||||
| 1893196/01 | Switzerland | ► Subscribe | PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013 | ||||||||||||
| 2011000010 | Germany | ► Subscribe | PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||
| C0028 | France | ► Subscribe | PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425 | ||||||||||||
| 90060-0 | Sweden | ► Subscribe | PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621 | ||||||||||||
| 2013000155 | Germany | ► Subscribe | PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621 | ||||||||||||
| 785 | Luxembourg | ► Subscribe | 91785, EXPIRES: 20250621 | ||||||||||||
| 2004 00037 | Denmark | ► Subscribe | |||||||||||||
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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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