TERBUTALINE SULFATE Drug Patent 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 Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, 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.
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Questions you can ask:
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Summary for TERBUTALINE SULFATE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 3 |
| Patent Applications: | 2,397 |
| 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 |
|---|---|
| Kanecia Zimmerman, MD MPH | Phase 2/Phase 3 |
| The Emmes Company, LLC | Phase 2/Phase 3 |
| Duke Health | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Areva Pharms | TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 200122-001 | Nov 8, 2013 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 075877-001 | Jun 26, 2001 | AB | RX | No | No | ⤷ 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 | ||||
| Twi Pharms | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 211832-002 | Jun 19, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Impax Labs | TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 075877-002 | Jun 26, 2001 | AB | RX | No | 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 |
