LOFEXIDINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Lofexidine Hydrochloride, and what generic alternatives are available?
Lofexidine Hydrochloride is a drug marketed by MSN, Novitium Pharma, and Regcon Holdings. and is included in three NDAs.
The generic ingredient in LOFEXIDINE HYDROCHLORIDE is lofexidine hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the lofexidine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lofexidine Hydrochloride
A generic version of LOFEXIDINE HYDROCHLORIDE was approved as lofexidine hydrochloride by REGCON HOLDINGS on August 20th, 2024.
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Questions you can ask:
- What is the 5 year forecast for LOFEXIDINE HYDROCHLORIDE?
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- What is Average Wholesale Price for LOFEXIDINE HYDROCHLORIDE?
Summary for LOFEXIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 43 |
| Patent Applications: | 245 |
| 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 |
|---|---|
| Yale University | PHASE1 |
| RTI International | PHASE1 |
| VA Connecticut Healthcare System | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msn | LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218699-001 | Feb 24, 2025 | 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 | |||
| Regcon Holdings | LOFEXIDINE HYDROCHLORIDE | lofexidine hydrochloride | TABLET;ORAL | 218613-001 | Aug 20, 2024 | AB | RX | No | No | ⤷ 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 |
