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Last Updated: January 18, 2021

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 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, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Oxford Pharms, Pliva, Prinston Inc, Rubicon, Sandoz, Sun Pharm Inds Ltd, Unichem, Upsher Smith Labs, 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 sixteen drug master file entries for cyclobenzaprine hydrochloride. Fifty-one 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
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Apsen Farmaceutica S.A.Phase 3
Cognitive Research CorporationPhase 1

See all cyclobenzaprine hydrochloride clinical trials

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial30MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial15MGCAPSULE, 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 NDA Submissiondate
AMRIX CAPSULE, EXTENDED RELEASE;ORAL cyclobenzaprine hydrochloride 021777 2008-08-11
FLEXERIL TABLET;ORAL cyclobenzaprine hydrochloride 017821

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
Jubilant Cadista CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077563-003 Aug 25, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Anda Repository CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073541-002 Apr 6, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 074421-001 Sep 29, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 077797-001 Feb 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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