CYCLOBENZAPRINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Cyclobenzaprine Hydrochloride, and when can generic versions of Cyclobenzaprine Hydrochloride launch?
Cyclobenzaprine Hydrochloride is a drug marketed by 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, and Watson Labs. and is included in twenty-two NDAs.
The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclobenzaprine Hydrochloride
A generic version of CYCLOBENZAPRINE HYDROCHLORIDE was approved as cyclobenzaprine hydrochloride by ACTAVIS LABS FL INC on May 3rd, 1989.
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Summary for CYCLOBENZAPRINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 54 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 40 |
| Patent Applications: | 1,249 |
| 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 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Ltd | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078722-002 | May 12, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 077797-002 | Feb 28, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Unichem | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 213324-003 | Jul 5, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
