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Generated: September 20, 2017

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TRAZODONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for trazodone hydrochloride and what is the scope of trazodone hydrochloride patent protection?

Trazodone hydrochloride
is the generic ingredient in four branded drugs marketed by Mylan, Pragma Pharms Llc, Angelini Pharma, Watson Labs, Alvogen, Mylan Pharms Inc, Quantum Pharmics, Accord Hlthcare, Teva Pharms Usa, Pliva, Sun Pharm Inds, Am Therap, Teva, Apotex, Torrent Pharms Ltd, Sandoz, Aurolife Pharma Llc, Usl Pharma, Vintage, and Apotex Inc, and is included in thirty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Trazodone hydrochloride has ninety-three patent family members in thirty-three countries.

There are thirteen drug master file entries for trazodone hydrochloride. Forty-three suppliers are listed for this compound.

Summary for Generic Name: TRAZODONE HYDROCHLORIDE

Tradenames:4
Patents:3
Applicants:20
NDAs:30
Drug Master File Entries: see list13
Suppliers / Packagers: see list43
Bulk Api Vendors: see list57
Clinical Trials: see list2,304
Patent Applications: see list1,671
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:TRAZODONE HYDROCHLORIDE at DailyMed

Pharmacology for Ingredient: TRAZODONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL090514-001Jun 2, 2009DISCNNoNo► Subscribe► Subscribe► 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
Apotex Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071196-002Apr 26, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Quantum Pharmics
TRIALODINE
trazodone hydrochloride
TABLET;ORAL070942-001Dec 1, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Usl Pharma
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL070491-001Apr 29, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Am Therap
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071140-001Oct 29, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071113-001Nov 17, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurolife Pharma Llc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL072484-001Apr 30, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: trazodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 1985► Subscribe► Subscribe
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 1985► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: trazodone hydrochloride

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
8,962,019Sustained drug release composition► Subscribe
9,439,866Trazodone composition for once a day administration► Subscribe
8,795,723Sustained drug release compositions► Subscribe
8,414,919Sustained 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 Ingredient: trazodone hydrochloride

Country Document Number Estimated Expiration
Russian Federation2008113439► Subscribe
South Korea20140133901► Subscribe
Portugal2178850► Subscribe
Canada2693095► Subscribe
European Patent Office1305009► Subscribe
Czech Republic300152► Subscribe
South Korea101655455► Subscribe
China100352509► Subscribe
Canada2616204► Subscribe
Norway20081731► 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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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Chubb
US Army
Novartis
Harvard Business School
Cantor Fitzgerald
Farmers Insurance
Fuji
Citi
QuintilesIMS

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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