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Plecanatide - Generic Drug Details
What are the generic sources for plecanatide and what is the scope of freedom to operate?
Plecanatide
is the generic ingredient in one branded drug marketed by Salix and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Plecanatide has fifty-eight patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for plecanatide
| International Patents: | 58 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 7 |
| Clinical Trials: | 10 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for plecanatide |
| DailyMed Link: | plecanatide at DailyMed |
Recent Clinical Trials for plecanatide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Synergy Pharmaceuticals Inc. | Phase 3 |
| INC Research | Phase 3 |
| Synergy Pharmaceuticals Inc. | Phase 2 |
Recent Litigation for plecanatide
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc. | 2016-11-30 |
Pharmacology for plecanatide
| Drug Class | Guanylate Cyclase-C Agonist |
| Mechanism of Action | Guanylate Cyclase Activators |
Synonyms for plecanatide
| (3-Glutamic acid(D>E))human uroguanylin (UGN) |
| [3-glutamic acid(D>E)]human uroguanylin |
| 467426-54-6 |
| 7IK8Z952OK |
| CHEMBL2103867 |
| DB13170 |
| DTXSID60196933 |
| GTPL9069 |
| Guanilib |
| Plecanatide [USAN:INN] |
| SP-304 |
| Trulance |
| UNII-7IK8Z952OK |
US Patents and Regulatory Information for plecanatide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for plecanatide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 102643333 | Start Trial |
| China | 105764916 | Start Trial |
| Hong Kong | 1196135 | Start Trial |
| Japan | 2009001582 | Start Trial |
| Australia | 2016216716 | Start Trial |
| Japan | 2017061478 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012037380 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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