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Generated: November 22, 2017

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Cyclobenzaprine hydrochloride - Generic Drug Details

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

Cyclobenzaprine hydrochloride
is the generic ingredient in three branded drugs marketed by Oxford Pharms, Actavis Labs Fl Inc, Orit Labs Llc, Pliva, Janssen Res And Dev, Sun Pharm Inds Ltd, Watson Labs, Frontida Biopharm, Aurobindo Pharma, Mylan Pharms Inc, Kvk Tech, Upsher-smith Labs, Jubilant Cadista, Rubicon Res Pvt Ltd, Teva Pharms Intl, Invagen Pharms, Twi Pharms Inc, Sandoz, and Prinston Inc, and is included in twenty NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cyclobenzaprine hydrochloride has one patent family member in one country.

There are fifteen drug master file entries for cyclobenzaprine hydrochloride. Seventy-five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for cyclobenzaprine hydrochloride

Tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe15MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe30MGCAPSULE, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms Intl
AMRIX
cyclobenzaprine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021777-002Feb 1, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Pharms Intl
AMRIX
cyclobenzaprine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021777-002Feb 1, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL090478-002Jul 23, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Intl
AMRIX
cyclobenzaprine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021777-002Feb 1, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Orit Labs Llc
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL078218-002Jun 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Pliva
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL074421-001Sep 29, 1995ABRXNoNo► Subscribe► Subscribe► Subscribe
Oxford Pharms
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL077209-001Oct 4, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride
TABLET;ORAL073143-001Nov 27, 1991DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cyclobenzaprine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Janssen Res And Dev
FLEXERIL
cyclobenzaprine hydrochloride
TABLET;ORAL017821-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cyclobenzaprine 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
8,877,245Modified release dosage forms of skeletal muscle relaxants► 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: cyclobenzaprine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005048996► 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 leading biopharmaceutical companies globally:

Accenture
Cipla
Argus Health
Deloitte
Johnson and Johnson
Citi
Medtronic
Moodys
Cantor Fitzgerald
Novartis

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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