ISONIAZID - Generic Drug Details
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What are the generic drug sources for isoniazid and what is the scope of patent protection?
Isoniazid
is the generic ingredient in eleven branded drugs marketed by Sandoz, Roche, Chartwell Rx, Cmp Pharma Inc, Lannett, Dow Pharm, Medpointe Pharm Hlc, Novartis, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, Whiteworth Town Plsn, Chartwell Molecular, Bristol Myers Squibb, Everylife, and Sanofi Aventis Us, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for isoniazid. Sixteen suppliers are listed for this compound.
Summary for ISONIAZID
| US Patents: | 0 |
| Tradenames: | 11 |
| Applicants: | 32 |
| NDAs: | 47 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 153 |
| Clinical Trials: | 226 |
| Patent Applications: | 6,720 |
| Drug Prices: | Drug price trends for ISONIAZID |
| What excipients (inactive ingredients) are in ISONIAZID? | ISONIAZID excipients list |
| DailyMed Link: | ISONIAZID at DailyMed |
Recent Clinical Trials for ISONIAZID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Freundeskreis Für Internationale Tuberkulosehilfe e.V | Phase 3 |
| Jawaharlal Institute of Postgraduate Medical Education & Research | Phase 3 |
| North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences | Phase 3 |
Pharmacology for ISONIAZID
| Drug Class | Antimycobacterial |
Medical Subject Heading (MeSH) Categories for ISONIAZID
Anatomical Therapeutic Chemical (ATC) Classes for ISONIAZID
US Patents and Regulatory Information for ISONIAZID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medpointe Pharm Hlc | HYZYD | isoniazid | TABLET;ORAL | 080134-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | ISONIAZID | isoniazid | TABLET;ORAL | 080523-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Purepac Pharm | ISONIAZID | isoniazid | TABLET;ORAL | 080132-003 | Jul 14, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | ISONIAZID | isoniazid | TABLET;ORAL | 085790-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Omnivium Pharms | ISONIAZID | isoniazid | TABLET;ORAL | 040090-001 | Jun 26, 1997 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nexgen Pharma Inc | ISONIAZID | isoniazid | TABLET;ORAL | 084050-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mk Labs | ISONIAZID | isoniazid | TABLET;ORAL | 080941-001 | Approved Prior to Jan 1, 1982 | 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 |
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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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