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, 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 |
Generic filers with tentative approvals for CYCLOBENZAPRINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 30MG | CAPSULE, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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
Expired US Patents for cyclobenzaprine hydrochloride
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