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, Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, 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. Twelve suppliers are listed for this compound.
Summary for terbutaline sulfate
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 13 |
| NDAs: | 15 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 3 |
| Patent Applications: | 3,754 |
| Drug Prices: | Drug price trends for terbutaline sulfate |
| What excipients (inactive ingredients) are in terbutaline sulfate? | terbutaline sulfate excipients list |
| DailyMed Link: | terbutaline sulfate at DailyMed |
Recent Clinical Trials for terbutaline sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke Health | Phase 2/Phase 3 |
| Kanecia Zimmerman, MD MPH | Phase 2/Phase 3 |
| The Emmes Company, LLC | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for terbutaline sulfate
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma Farmaceutica | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 078630-001 | May 20, 2009 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 076887-001 | May 26, 2004 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Injectable | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 076770-001 | Apr 23, 2004 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Epic Pharma Llc | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 078151-001 | Jan 7, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | AEROSOL, METERED;INHALATION | 018000-001 | Mar 19, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Twi Pharms | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 211832-001 | Jun 19, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | TABLET;ORAL | 017618-001 | 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 |
| Novartis | BRETHAIRE | terbutaline sulfate | AEROSOL, METERED;INHALATION | 018762-001 | Aug 17, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | AEROSOL, METERED;INHALATION | 018000-001 | Mar 19, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmacare | BRETHINE | terbutaline sulfate | INJECTABLE;INJECTION | 018571-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | BRICANYL | terbutaline sulfate | INJECTABLE;INJECTION | 017466-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
