CYCLOBENZAPRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for cyclobenzaprine hydrochloride and what is the scope of freedom to operate?

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, 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-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CYCLOBENZAPRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	24
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	40
Patent Applications:	1,953
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYCLOBENZAPRINE HYDROCHLORIDE
What excipients (inactive ingredients) are in CYCLOBENZAPRINE HYDROCHLORIDE?	CYCLOBENZAPRINE HYDROCHLORIDE excipients list
DailyMed Link:	CYCLOBENZAPRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CYCLOBENZAPRINE HYDROCHLORIDE

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

Sponsor	Phase
Madigan Army Medical Center	Phase 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
		30MG	CAPSULE, EXTENDED RELEASE; ORAL
		15MG	CAPSULE, 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

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Anatomical Therapeutic Chemical (ATC) Classes for CYCLOBENZAPRINE HYDROCHLORIDE

M03BX	Other centrally acting agents
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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
Aiping Pharm Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	072854-002	Feb 3, 2006		DISCN	No	No
Anda Repository	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	073541-002	Apr 6, 2006	AB	RX	No	No
Prinston Inc	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	077797-001	Feb 28, 2007	AB	RX	No	No
Rising	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	073144-001	May 30, 1991		DISCN	No	No
Invagen Pharms	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	090478-001	Jul 23, 2010	AB	RX	No	No
Rubicon	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	208170-003	May 31, 2017	AB	RX	No	Yes
Watson Labs	CYCLOBENZAPRINE HYDROCHLORIDE	cyclobenzaprine hydrochloride	TABLET;ORAL	074436-001	Nov 30, 1994		DISCN	No	No

Expired US Patents for CYCLOBENZAPRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-002	Approved Prior to Jan 1, 1982
Janssen Res And Dev	FLEXERIL	cyclobenzaprine hydrochloride	TABLET;ORAL	017821-001	Approved Prior to Jan 1, 1982
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007