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Serving leading biopharmaceutical companies globally:

US Army
Teva
McKinsey
Chubb
Daiichi Sankyo
Accenture
Fuji
Cerilliant
Harvard Business School
Chinese Patent Office

Generated: October 19, 2017

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OLEPTRO Drug Profile

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What is the patent landscape for Oleptro, and when can generic versions of Oleptro launch?

Oleptro is a drug marketed by Angelini Pharma and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three patent family members in thirty-three countries.

The generic ingredient in OLEPTRO is trazodone hydrochloride. There are thirteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Summary for Tradename: OLEPTRO

US Patents:3
Applicants:1
NDAs:1
Bulk Api Vendors: see list90
Clinical Trials: see list8
Patent Applications: see list1,100
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OLEPTRO at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV (Patent) Challenges for OLEPTRO

Drugname Dosage Strength RLD Submissiondate
trazodone hydrochlorideExtended-release Tablets150 mg and 300 mgOleptro10/18/2010

Non-Orange Book Patents for Tradename: OLEPTRO

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
8,314,236Trazodone and trazodone hydrochloride in purified form► Subscribe
8,414,919Sustained drug release composition► Subscribe
8,962,019Sustained drug release composition► Subscribe
9,439,866Trazodone composition for once a day administration► Subscribe
8,795,723Sustained drug release 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 Tradename: OLEPTRO

Country Document Number Estimated Expiration
Germany60120413► Subscribe
Australia7148101► Subscribe
Canada2414349► Subscribe
Norway20026254► Subscribe
Norway20081731► Subscribe
Japan5025066► Subscribe
World Intellectual Property Organization (WIPO)0202084► Subscribe
Argentina059682► Subscribe
Japan2010535170► Subscribe
Eurasian Patent Organization014739► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Harvard Business School
Argus Health
Dow
Cantor Fitzgerald
Mallinckrodt
McKesson
Moodys
Queensland Health
Chubb

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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