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Last Updated: September 23, 2021

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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 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-seven 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
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Apsen Farmaceutica S.A.Phase 3

See all cyclobenzaprine hydrochloride clinical trials

Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free30MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free15MGCAPSULE, 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 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
Actavis Labs Fl Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611-002 Feb 3, 2006 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Twi Pharms Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091281-002 Jan 31, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078643-002 Sep 26, 2008 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Pharms Inc CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144-003 Mar 25, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alembic Labs CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078218-003 Nov 3, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Janssen Res And Dev FLEXERIL cyclobenzaprine hydrochloride TABLET;ORAL 017821-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Dow
Moodys
McKinsey
Mallinckrodt

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