BRETHINE Drug Patent Profile
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Which patents cover Brethine, and what generic alternatives are available?
Brethine is a drug marketed by Pharmacare and Ani Pharms and is included in two NDAs.
The generic ingredient in BRETHINE is terbutaline sulfate. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Brethine
A generic version of BRETHINE was approved as terbutaline sulfate by IMPAX LABS on June 26th, 2001.
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Summary for BRETHINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,693 |
| DailyMed Link: | BRETHINE at DailyMed |
Recent Clinical Trials for BRETHINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yaakov Beilin | Phase 2/Phase 3 |
| Jaeb Center for Health Research | Phase 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
US Patents and Regulatory Information for BRETHINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 BRETHINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | 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 BRETHINE
See the table below for patents covering BRETHINE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 1643296 | ⤷ Sign Up | |
| Norway | 132866 | ⤷ Sign Up | |
| Norway | 124723 | ⤷ Sign Up | |
| Switzerland | 512428 | Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxy-phenyl)-2-aminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen | ⤷ Sign Up |
| Switzerland | 510625 | Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxy-phenyl)-2-aminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen (1-3 5-dihydroxyphenyl-2-alkylaminoethanols) | ⤷ Sign Up |
| Switzerland | 510627 | Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxyphenyl)-2-cyclobutylaminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen | ⤷ 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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