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TERBUTALINE SULFATE Drug Profile
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When do Terbutaline Sulfate patents expire, and when can generic versions of Terbutaline Sulfate launch?
Terbutaline Sulfate is a drug marketed by Akorn, Athenex Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, United Biomedcl, Impax Labs, Lannett Co Inc, and Twi Pharms. and is included in nine NDAs.
The generic ingredient in TERBUTALINE SULFATE 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 Terbutaline Sulfate
A generic version of TERBUTALINE SULFATE was approved as terbutaline sulfate by IMPAX LABS on June 26th, 2001.
Summary for TERBUTALINE SULFATE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,672 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|
| University of Mississippi Medical Center | N/A |
| American University of Beirut Medical Center | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Akorn | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 078151-001 | Jan 7, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 075877-001 | Jun 26, 2001 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 076887-001 | May 26, 2004 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Twi Pharms | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 211832-002 | Jun 19, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
