Lofexidine hydrochloride - Generic Drug Details
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 MSN, Novitium Pharma, Regcon Holdings, and Biocorrx Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.Seven suppliers are listed for this compound.
Summary for lofexidine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 43 |
| Patent Applications: | 335 |
| 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 |
|---|---|
| BioXcel Therapeutics Inc | PHASE1 |
| Yale University | PHASE1 |
| RTI International | PHASE1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Regcon Holdings | LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218613-001 | Aug 20, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Novitium Pharma | LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 219917-001 | Oct 22, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Biocorrx Pharms | LUCEMYRA | lofexidine hydrochloride | TABLET;ORAL | 209229-001 | May 16, 2018 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
