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Last Updated: November 2, 2024

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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Drug patent expirations by year for BRETHINE
Recent Clinical Trials for BRETHINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yaakov BeilinPhase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1
Jaeb Center for Health ResearchPhase 1

See all BRETHINE clinical trials

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
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
Ani Pharms BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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