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Last Updated: March 28, 2024

Terbutaline sulfate - Generic Drug Details


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What are the generic drug sources for terbutaline sulfate and what is the scope of freedom to operate?

Terbutaline sulfate is the generic ingredient in four branded drugs marketed by Novartis, Sanofi Aventis Us, Pharmacare, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, United Biomedcl, Ani Pharms, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for terbutaline sulfate. Thirteen suppliers are listed for this compound.

Drug Prices for terbutaline sulfate

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Recent Clinical Trials for terbutaline sulfate

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

SponsorPhase
The Emmes Company, LLCPhase 2/Phase 3
Duke HealthPhase 2/Phase 3
Kanecia Zimmerman, MD MPHPhase 2/Phase 3

See all terbutaline sulfate clinical trials

Medical Subject Heading (MeSH) Categories for terbutaline sulfate

US Patents and Regulatory Information for terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Twi Pharms TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 211832-002 Jun 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076853-001 Jul 20, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Sanofi Aventis Us BRICANYL terbutaline sulfate AEROSOL, METERED;INHALATION 018000-001 Mar 19, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Injectable TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076770-001 Apr 23, 2004 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 077152-002 Mar 25, 2005 AB RX No Yes ⤷  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 terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-002 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
Novartis BRETHAIRE terbutaline sulfate AEROSOL, METERED;INHALATION 018762-001 Aug 17, 1984 ⤷  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
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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