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 |
Christian Medical College, Vellore, India | Phase 3 |
Indian Council of Medical Research | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Phoenix Labs Ny | ISONIAZID | isoniazid | TABLET;ORAL | 080368-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sanofi Aventis Us | RIFATER | isoniazid; pyrazinamide; rifampin | TABLET;ORAL | 050705-001 | May 31, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs | ISONIAZID | isoniazid | TABLET;ORAL | 080521-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ivax Sub Teva Pharms | ISONIAZID | isoniazid | TABLET;ORAL | 083610-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Industries | ISONIAZID | isoniazid | TABLET;ORAL | 083633-001 | 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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