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Generated: August 21, 2017
What is the competitive landscape for ASTELLAS, and what generic alternatives to ASTELLAS drugs are available?
ASTELLAS has thirty-one approved drugs.| Patents: | 30 |
| Tradenames: | 17 |
| Ingredients: | 13 |
| NDAs: | 31 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astellas | CEFIZOX | ceftizoxime sodium | INJECTABLE;INJECTION | 050560-001 | Sep 15, 1983 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astellas | ARISTOCORT | triamcinolone acetonide | OINTMENT;TOPICAL | 080750-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;IV (INFUSION) | 207501-001 | Mar 6, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astellas | CYCLOCORT | amcinonide | CREAM;TOPICAL | 018116-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astellas | CYCLOCORT | amcinonide | LOTION;TOPICAL | 019729-001 | Jun 13, 1988 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;IV (INFUSION) | 021506-003 | Jun 27, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astellas | ADENOSCAN | adenosine | SOLUTION;IV (INFUSION) | 020059-001 | May 18, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;IV (INFUSION) | 021506-002 | Mar 16, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astellas | PROGRAF | tacrolimus | INJECTABLE;INJECTION | 050709-001 | Apr 8, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astellas | ADENOSCAN | adenosine | SOLUTION;IV (INFUSION) | 020059-001 | May 18, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,956,179 | Process for preparing an A2A-adenosine receptor agonist and its polymorphs | ► Subscribe | |||||||||||||||||||||||||||
| 7,112,565 | Stabilized pharmaceutical composition in lyophilized form | ► Subscribe | |||||||||||||||||||||||||||
| 7,151,182 | Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 8,648,105 | Diarylthiohydantoin compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,770,290 | Amphotericin B liposome preparation | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 298144 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2016183200 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 229089 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2007127010 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2449993 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90003-2.L | Sweden | ► Subscribe | PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906 | ||||||||||||||||||||||||||
| C0096 | France | ► Subscribe | PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015 | ||||||||||||||||||||||||||
| 90060-0 | Sweden | ► Subscribe | PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621 | ||||||||||||||||||||||||||
| 2014000122 | Germany | ► Subscribe | PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 | ||||||||||||||||||||||||||
| C0071 | France | ► Subscribe | PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625 | ||||||||||||||||||||||||||
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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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