BRETHINE Drug Patent Profile
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Which patents cover Brethine, and when can generic versions of Brethine launch?
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. Eleven 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.
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: | 3,950 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for BRETHINE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 BRETHINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | 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 BRETHINE
See the table below for patents covering BRETHINE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Netherlands | 7513854 | ⤷ Try a Trial | |
Sweden | 335359 | ⤷ Try a Trial | |
Norway | 120686 | ⤷ Try a Trial | |
Austria | 286964 | ⤷ Try a Trial | |
Spain | 361432 | ⤷ Try a Trial | |
Finland | 54798 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |