HYDRALAZINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for hydralazine hydrochloride and what is the scope of freedom to operate?
Hydralazine hydrochloride
is the generic ingredient in twenty-eight branded drugs marketed by Novartis, Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Riconpharma Llc, and is included in one hundred and twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for hydralazine hydrochloride. Forty-two suppliers are listed for this compound.
Summary for HYDRALAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 28 |
| Applicants: | 52 |
| NDAs: | 125 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 42 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 65 |
| Patent Applications: | 1,703 |
| Drug Prices: | Drug price trends for HYDRALAZINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in HYDRALAZINE HYDROCHLORIDE? | HYDRALAZINE HYDROCHLORIDE excipients list |
| DailyMed Link: | HYDRALAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McMaster University | Phase 3 |
| Shahid Sadoughi University of Medical Sciences and Health Services | Phase 3 |
| National Institute for Medical Research Development (NIMAD), Iran | Phase 3 |
Pharmacology for HYDRALAZINE HYDROCHLORIDE
| Drug Class | Arteriolar Vasodilator |
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for HYDRALAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE
US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Superpharm | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 088789-001 | Aug 28, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | CAM-AP-ES | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 084897-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cadila Pharms Ltd | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 203845-003 | Sep 18, 2014 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ivax Sub Teva Pharms | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 084469-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Iii | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 040901-001 | Sep 12, 2008 | AA | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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