TEDUGLUTIDE RECOMBINANT - Generic Drug Details
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What are the generic 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 Takeda Pharms Usa and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Teduglutide recombinant has eight patent family members in seven countries.
One supplier is listed for this compound.
Summary for TEDUGLUTIDE RECOMBINANT
International Patents: | 8 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 35 |
Patent Applications: | 767 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TEDUGLUTIDE RECOMBINANT |
DailyMed Link: | TEDUGLUTIDE RECOMBINANT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEDUGLUTIDE RECOMBINANT
Generic Entry Date for TEDUGLUTIDE RECOMBINANT*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT Dosage:
POWDER;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TEDUGLUTIDE RECOMBINANT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allegheny Singer Research Institute | Phase 3 |
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Phase 3 |
Takeda Development Center Americas, Inc. | Phase 1 |
Pharmacology for TEDUGLUTIDE RECOMBINANT
Ingredient-type | Analogs/Derivatives Glucagon-Like Peptide 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Takeda Pharms Usa | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Takeda Pharms Usa | GATTEX KIT | teduglutide recombinant | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1809318 | TRAITEMENT DE PATIENTS ATTEINTS DU SYNDROME DE L'INTESTIN COURT AVEC COLON EN CONTINUITE (TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006050244 | ⤷ Try a Trial | |
Spain | 2427150 | ⤷ Try a Trial | |
Hong Kong | 1107026 | TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY | ⤷ Try a Trial |
Denmark | 1809318 | ⤷ Try a Trial | |
Japan | 5197012 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEDUGLUTIDE RECOMBINANT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0906338 | 2013/006 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
0906338 | 92153 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE |
0906338 | 13C0013 | France | ⤷ Try a Trial | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
0906338 | C300578 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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