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.
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Summary for SEPTRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 23 |
| DailyMed Link: | SEPTRA at DailyMed |
Recent Clinical Trials for SEPTRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roswell Park Cancer Institute | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
| Cidara Therapeutics Inc. | Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Monarch Pharms | SEPTRA DS | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017376-002 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 017598-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Monarch Pharms | SEPTRA | sulfamethoxazole; trimethoprim | TABLET;ORAL | 017376-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Monarch Pharms | SEPTRA GRAPE | sulfamethoxazole; trimethoprim | SUSPENSION;ORAL | 017598-002 | Feb 12, 1986 | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Kenya | 3038 | TABLET FORMULATION | ⤷ Sign Up |
| Denmark | 143247 | ⤷ Sign Up | |
| Guatemala | 197960431 | FORMULACION DE TABLETAS DE BASE DE 2,4-DIAMINO-5-BENCILPIRI-MIDINA Y UNA SULFONAMIDA ADECUADA PARA ADMINISTRACION ORAL. | ⤷ Sign Up |
| Norway | 146043 | ⤷ Sign Up | |
| Denmark | 52875 | ⤷ Sign Up | |
| Zambia | 2976 | TABLET FORMULATION | ⤷ Sign Up |
| Spain | 434688 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated 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.
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