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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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