CLONIDINE HYDROCHLORIDE Drug Patent Profile
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When do Clonidine Hydrochloride patents expire, and what generic alternatives are available?
Clonidine Hydrochloride is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Chartwell Rx, Dr Reddys Labs Sa, Endo Operations, Jubilant Generics, Novast Labs, Somerset Theraps Llc, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Impax Labs, Interpharm, Par Pharm, Prinston Inc, Rising, Sun Pharm Inds Inc, Teva, Trupharma, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm. and is included in fifty-seven NDAs.
The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
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Summary for CLONIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 57 |
| Finished Product Suppliers / Packagers: | 43 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 378 |
| Patent Applications: | 1,871 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLONIDINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in CLONIDINE HYDROCHLORIDE? | CLONIDINE HYDROCHLORIDE excipients list |
| DailyMed Link: | CLONIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CLONIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad Simón Bolívar | Phase 3 |
| National Cancer Institute, Egypt | N/A |
| Sollis Therapeutics, Inc. | Phase 3 |
Pharmacology for CLONIDINE HYDROCHLORIDE
| Drug Class | Central alpha-2 Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha2-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for CLONIDINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CLONIDINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KAPVAY | Extended-release Tablets | clonidine hydrochloride | 0.1 mg and 0.2 mg | 022331 | 1 | 2011-03-04 |
US Patents and Regulatory Information for CLONIDINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warner Chilcott | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 072138-001 | Jun 13, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecules | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 071785-001 | Apr 5, 1988 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic Pharms Ltd | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 091368-003 | Dec 6, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Par Pharm | CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE | chlorthalidone; clonidine hydrochloride | TABLET;ORAL | 071142-001 | Dec 16, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Interpharm | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 071253-001 | Oct 1, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Inds Inc | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 090329-001 | Jul 3, 2014 | DISCN | 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 |
