SEPTRA Drug Patent Profile
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Which patents cover Septra, and when can generic versions of Septra launch?
Septra is a drug marketed by Monarch Pharms and is included in three NDAs.
The generic ingredient in SEPTRA is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Septra
A generic version of SEPTRA was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25th, 1986.
Summary for SEPTRA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 23 |
Formulation / Manufacturing: | see details |
DailyMed Link: | SEPTRA at DailyMed |
Recent Clinical Trials for SEPTRA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 4 |
Roswell Park Cancer Institute | Phase 4 |
Cidara Therapeutics Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for SEPTRA
US Patents and Regulatory Information for SEPTRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | INJECTABLE;INJECTION | 018452-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Monarch Pharms | SEPTRA DS | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017376-002 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 017598-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017376-001 | Approved Prior to Jan 1, 1982 | AB | RX | 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 SEPTRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017376-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SEPTRA
See the table below for patents covering SEPTRA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 71835 | ⤷ Try a Trial | |
German Democratic Republic | 118228 | ⤷ Try a Trial | |
Australia | 468465 | ⤷ Try a Trial | |
Hungary | 171536 | SPOSOB POLUCHENIJA TABLETOK SODERZHAHHIKH SUL'FONAMIDA I DIAMINOPIRIMIDINA (PROCESS FOR PRODUCING TABLETS, CONTAINING SULFONAMIDE AND DIAMINOPYRIMIDINE) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |