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Teduglutide recombinant - Generic Drug Details
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What are the generic drug sources for teduglutide recombinant and what is the scope of freedom to operate?
Teduglutide recombinant
is the generic ingredient in one branded drug marketed by Nps Pharms Inc and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Teduglutide recombinant has eighty-two patent family members in eighteen countries.
There is one drug master file entry for teduglutide recombinant. One supplier is listed for this compound.
Summary for teduglutide recombinant
| International Patents: | 82 |
| US Patents: | 21 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 34 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for teduglutide recombinant |
| DailyMed Link: | teduglutide recombinant at DailyMed |
Recent Clinical Trials for teduglutide recombinant
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda Development Center Americas, Inc. | Phase 1 |
| Allegheny Singer Research Institute | Phase 3 |
| Queen Mary University of London | Phase 2 |
Pharmacology for teduglutide recombinant
| Ingredient-type | Glucagon-Like Peptide 2 Analogs/Derivatives |
| Drug Class | GLP-2 Analog |
| Mechanism of Action | Glucagon-like Peptide-2 (GLP-2) Agonists |
US Patents and Regulatory Information for teduglutide recombinant
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nps Pharms Inc | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Nps Pharms Inc | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Nps Pharms Inc | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Nps Pharms Inc | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Nps Pharms Inc | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | 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 teduglutide recombinant
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1809318 | Start Trial |
| European Patent Office | 1246639 | Start Trial |
| Japan | 5019466 | Start Trial |
| Canada | 2585482 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0149314 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for teduglutide recombinant
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0906338 | C300578 | Netherlands | Start Trial | PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
| 0906338 | 13C0013 | France | Start Trial | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
| 0906338 | 1390009-7 | Sweden | Start Trial | PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830 |
| 0906338 | 433 | Finland | Start Trial | |
| 0906338 | 2013/006 | Ireland | Start Trial | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
ISSN: 2162-2639
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