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Trazodone hydrochloride - Generic Drug Details

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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, 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 twenty-nine NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-eight patent family members in thirty-two countries.

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

Summary for Generic Name: trazodone hydrochloride

Tradenames:4
Patents:3
Applicants:19
NDAs:29
Drug Master File Entries: see list13
Suppliers / Packaging: see list45
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: trazodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Usl Pharma
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL070491-001Apr 29, 1987DISCNNo► subscribe► subscribe
Sun Pharm Inds
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL073137-003Dec 22, 1995RXNo► subscribe► subscribe
Apotex Inc
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL071196-001Mar 25, 1987RXYes► 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, 19854,258,027► subscribe
Pragma Pharms Llc
DESYREL
trazodone hydrochloride
TABLET;ORAL018207-003Mar 25, 19854,215,104► 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
8,795,723Sustained drug release compositions► subscribe
8,962,019Sustained drug release composition► subscribe
8,314,236Trazodone and trazodone hydrochloride in purified form► 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
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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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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