Lofexidine hydrochloride - Generic Drug Details
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What are the generic sources for lofexidine hydrochloride and what is the scope of freedom to operate?
Lofexidine hydrochloride
is the generic ingredient in two branded drugs marketed by Indoco and Uswm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Four suppliers are listed for this compound.
Summary for lofexidine hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 42 |
Patent Applications: | 271 |
What excipients (inactive ingredients) are in lofexidine hydrochloride? | lofexidine hydrochloride excipients list |
DailyMed Link: | lofexidine hydrochloride at DailyMed |
Recent Clinical Trials for lofexidine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
USWM, LLC (dba US WorldMeds) | Phase 2 |
Clinilabs, Inc. | Phase 1/Phase 2 |
Yale University | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for lofexidine hydrochloride
US Patents and Regulatory Information for lofexidine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Uswm | LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229-001 | May 16, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Indoco | LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218613-001 | Aug 20, 2024 | 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 |