CLONIDINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for clonidine hydrochloride and what is the scope of freedom to operate?
Clonidine hydrochloride
is the generic ingredient in five branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Mylan Institutional, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Anchen Pharms, Bluepharma Industria, Chartwell Rx, Dr Reddys Labs Sa, Jubilant Generics, Novast Labs, Xiamen Lp Pharm Co, Concordia Pharms Inc, Boehringer Ingelheim, 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, Unichem, Url Labs, Warner Chilcott, Watson Labs, and Yung Shin Pharm, and is included in fifty-seven NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for clonidine hydrochloride. Forty suppliers are listed for this compound.
Summary for CLONIDINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 35 |
NDAs: | 57 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 136 |
Clinical Trials: | 372 |
Patent Applications: | 2,948 |
Formulation / Manufacturing: | see details |
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 |
---|---|
National Cancer Institute, Egypt | N/A |
Sollis Therapeutics, Inc. | Phase 3 |
Loyola University | Phase 4 |
Pharmacology for CLONIDINE HYDROCHLORIDE
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 070459-001 | Jul 8, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Yung Shin Pharm | CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 202297-002 | Jun 13, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Institutional | DURACLON | clonidine hydrochloride | INJECTABLE;INJECTION | 020615-002 | Apr 27, 1999 | 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 CLONIDINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | CATAPRES | clonidine hydrochloride | TABLET;ORAL | 017407-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Concordia Pharms Inc | KAPVAY | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-003 | Sep 28, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Concordia Pharms Inc | JENLOGA | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-001 | Sep 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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