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Serving 500+ biopharmaceutical companies globally:

Novartis
Queensland Health
AstraZeneca
Dow
Covington
McKesson
Harvard Business School
McKinsey
Citi
Fuji

Generated: September 23, 2017

DrugPatentWatch Database Preview

Spectrum Pharms Company Profile

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What is the competitive landscape for SPECTRUM PHARMS, and when can generic versions of SPECTRUM PHARMS drugs launch?

SPECTRUM PHARMS has five approved drugs.

There are six US patents protecting SPECTRUM PHARMS drugs.

There are one hundred and nine patent family members on SPECTRUM PHARMS drugs in twenty-nine countries.

Summary for Applicant: Spectrum Pharms

Patents:6
Tradenames:4
Ingredients:4
NDAs:5
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spectrum Pharms
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION012209-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION087792-001Oct 13, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
BELEODAQ
belinostat
POWDER;IV (INFUSION)206256-001Jul 3, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-003Apr 29, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Spectrum Pharms
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION012209-002Jul 29, 2016DISCNYesNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Spectrum Pharms
BELEODAQ
belinostat
POWDER;IV (INFUSION)206256-001Jul 3, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV activity for SPECTRUM PHARMS drugs

Drugname Dosage Strength Tradename Submissiondate
levoleucovorin calcium
Injection50 mg/vial
FUSILEV
12/19/2013
levoleucovorin calcium
Injection10 mg/mL, 17.5 mL vial and 25 mL vial
FUSILEV
10/26/2011

Non-Orange Book Patents for Spectrum Pharms

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
4,959,472 Process for preparing substantially pure diastereoisomers of tetrahydrofolic derivatives► Subscribe
7,557,140Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors► Subscribe
7,407,988Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors► Subscribe
7,183,298Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors► Subscribe
6,849,628 Optically active compounds► Subscribe
9,750,822Sulfoalkyl ether cyclodextrin compositions► Subscribe
7,635,773Sulfoalkyl ether cyclodextrin 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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International Patent Family for Spectrum Pharms Drugs

Country Document Number Estimated Expiration
Spain2191669► Subscribe
China102579417► Subscribe
Hong Kong1219883► Subscribe
Japan2012188444► Subscribe
Spain2189782► Subscribe
Japan5108750► Subscribe
South Korea20150004797► Subscribe
Austria231150► Subscribe
Australia9013101► Subscribe
European Patent Office2292593► 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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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Baxter
Teva
Deloitte
Boehringer Ingelheim
Novartis
Fish and Richardson
UBS
Accenture

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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