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OLEPTRO Drug Profile

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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 eighty-eight patent family members in thirty-two countries.

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

Summary for Tradename: OLEPTRO

Patents:3
Applicants:1
NDAs:1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNNo7,829,120► subscribeY ► subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNNo7,829,120► subscribeY ► subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNNo6,607,748► subscribeY ► subscribe
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Paragraph IV activity 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
8,414,919Sustained drug release composition► subscribe
8,314,236Trazodone and trazodone hydrochloride in purified form► subscribe
8,962,019Sustained drug release composition► 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
Portugal2178850► subscribe
BrazilPI0615577► subscribe
Japan2013116917► 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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