FLEXERIL Drug Patent Profile
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Which patents cover Flexeril, and when can generic versions of Flexeril launch?
Flexeril is a drug marketed by Janssen Res And Dev and is included in one NDA.
The generic ingredient in FLEXERIL is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Flexeril
A generic version of FLEXERIL was approved as cyclobenzaprine hydrochloride by ACTAVIS LABS FL INC on May 3rd, 1989.
Summary for FLEXERIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,249 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FLEXERIL at DailyMed |
Recent Clinical Trials for FLEXERIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Augusta University | Phase 4 |
| Cognitive Research Corporation | Phase 1 |
| Neurana Pharmaceuticals, Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for FLEXERIL
US Patents and Regulatory Information for FLEXERIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 FLEXERIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Res And Dev | FLEXERIL | cyclobenzaprine hydrochloride | TABLET;ORAL | 017821-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
