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Last Updated: September 26, 2022

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, Twi Pharms Inc, Actavis Labs Fl Inc, Alembic Labs, Anda Repository, Aurobindo Pharma, Chartwell Rx, 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-two NDAs. There are eight 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 ten drug master file entries for cyclobenzaprine hydrochloride. Fifty-four 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
See Plans and PricingSee Plans and Pricing30MGCAPSULE, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing15MGCAPSULE, 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
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
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Oxford Pharms CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077209-001 Oct 4, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144-002 Feb 3, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722-001 May 12, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rubicon CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 208170-001 May 31, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206703-001 Jul 24, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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