NALIDIXIC ACID - Generic Drug Details
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What are the generic sources for nalidixic acid and what is the scope of patent protection?
Nalidixic acid
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Sun Pharm Industries, and Watson Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for nalidixic acid.
Summary for NALIDIXIC ACID
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 8 |
Drug Master File Entries: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 6 |
Patent Applications: | 6,560 |
Formulation / Manufacturing: | see details |
DailyMed Link: | NALIDIXIC ACID at DailyMed |
Recent Clinical Trials for NALIDIXIC ACID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Albany Medical College | N/A |
Alexandra Hospital, Athens, Greece | Phase 4 |
Hellenic Society of Gastroenterology | Phase 4 |
Medical Subject Heading (MeSH) Categories for NALIDIXIC ACID
US Patents and Regulatory Information for NALIDIXIC ACID
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi Aventis Us | NEGGRAM | nalidixic acid | TABLET;ORAL | 014214-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | NALIDIXIC ACID | nalidixic acid | TABLET;ORAL | 072061-001 | Jun 29, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Industries | NALIDIXIC ACID | nalidixic acid | TABLET;ORAL | 070270-001 | Jun 29, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Industries | NALIDIXIC ACID | nalidixic acid | TABLET;ORAL | 070271-001 | Jun 29, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | NEGGRAM | nalidixic acid | SUSPENSION;ORAL | 017430-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 NALIDIXIC ACID
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | NEGGRAM | nalidixic acid | TABLET;ORAL | 014214-005 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | NEGGRAM | nalidixic acid | SUSPENSION;ORAL | 017430-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | NEGGRAM | nalidixic acid | TABLET;ORAL | 014214-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | NEGGRAM | nalidixic acid | SUSPENSION;ORAL | 017430-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | NEGGRAM | nalidixic acid | TABLET;ORAL | 014214-004 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |