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Last Updated: November 24, 2024

Cyclobenzaprine hydrochloride - Generic Drug Details


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

Cyclobenzaprine hydrochloride is the generic ingredient in three branded drugs marketed by Teva Pharms Intl, Apotex, Macleods Pharms Ltd, Novast Labs, Twi Pharms Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Anda Repository, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon, Sandoz, Sun Pharm Inds Ltd, Unichem, Watson Labs, and Janssen Res And Dev, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cyclobenzaprine hydrochloride. Fifty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for cyclobenzaprine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Madigan Army Medical CenterPhase 4
Apsen Farmaceutica S.A.Phase 3
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4

See all cyclobenzaprine hydrochloride clinical trials

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up30MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up15MGCAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for cyclobenzaprine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for cyclobenzaprine hydrochloride
Paragraph IV (Patent) Challenges for CYCLOBENZAPRINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AMRIX Extended-release Capsule cyclobenzaprine hydrochloride 15 mg and 30 mg 021777 1 2008-08-11

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
Oxford Pharms CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077209-002 Feb 3, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611-001 May 3, 1989 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Graviti Pharms CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 218936-001 Sep 12, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144-001 May 30, 1991 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611-003 Feb 3, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 072854-001 Nov 19, 1991 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 213324-001 Jul 6, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.