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Serving leading biopharmaceutical companies globally:

Julphar
Citi
McKesson
Fish and Richardson
Cantor Fitzgerald
Moodys
Deloitte
US Army
Dow
QuintilesIMS

Generated: February 22, 2018

DrugPatentWatch Database Preview

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 Teva Pharms Intl, Twi Pharms Inc, Actavis Labs Fl Inc, Aurobindo Pharma, Frontida Biopharm, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon Res Pvt Ltd, Sandoz, Sun Pharm Inds Ltd, Upsher-smith Labs, Watson Labs, and Janssen Res And Dev, 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. Eighty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for cyclobenzaprine hydrochloride
Pharmacology for cyclobenzaprine hydrochloride
Tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial15MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Try a Free Trial➤ Try a Free Trial30MGCAPSULE, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for cyclobenzaprine 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 CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144-003 Mar 25, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Rubicon Res Pvt Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 208170-002 May 31, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Orit Labs Llc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078218-001 Apr 18, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Jubilant Cadista CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077563-001 Apr 19, 2006 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kvk Tech CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078048-001 Feb 28, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Twi Pharms Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091281-001 Jan 31, 2013 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Rubicon Res Pvt Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 208170-001 May 31, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Frontida Biopharm CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073541-002 Apr 6, 2006 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for cyclobenzaprine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,877,245 Modified release dosage forms of skeletal muscle relaxants ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chinese Patent Office
Chubb
Healthtrust
Farmers Insurance
US Army
Johnson and Johnson
Dow
Boehringer Ingelheim

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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