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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Daiichi Sankyo
Dow
US Army
Express Scripts
Chinese Patent Office
Fish and Richardson
Boehringer Ingelheim
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Generated: September 24, 2017

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Trazodone hydrochloride - Generic Drug Details

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What are the generic sources for trazodone hydrochloride and what is the scope of trazodone hydrochloride freedom to operate?

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-four 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 list44
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
Watson Labs
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL070857-001Oct 10, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-002Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL073137-003Dec 22, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL072483-001Apr 30, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Am Therap
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071140-001Oct 29, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Quantum Pharmics
TRIALODINE
trazodone hydrochloride
TABLET;ORAL070942-001Dec 1, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Angelini Pharma
OLEPTRO
trazodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022411-001Feb 2, 2010DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apotex Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071196-003Apr 26, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071196-001Mar 25, 1987ABRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL090514-003Jun 2, 2009DISCNNoNo► 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
Israel189139► Subscribe
Russian Federation2274443► Subscribe
World Intellectual Property Organization (WIPO)2007048220► Subscribe
China1449279► Subscribe
EcuadorSP088239► Subscribe
BrazilPI0814448► Subscribe
China101252932► Subscribe
South Africa200801162► Subscribe
Australia2006308448► 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.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Fuji
Medtronic
Cantor Fitzgerald
McKesson
Cipla
Novartis
Merck
Accenture
Queensland Health

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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