GVOKE PFS Drug Patent Profile
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When do Gvoke Pfs patents expire, and when can generic versions of Gvoke Pfs launch?
Gvoke Pfs is a drug marketed by Xeris and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-four patent family members in fifteen countries.
The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gvoke Pfs
A generic version of GVOKE PFS was approved as glucagon by FRESENIUS KABI USA on May 8th, 2015.
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Summary for GVOKE PFS
| International Patents: | 24 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 28 |
| Drug Prices: | Drug price information for GVOKE PFS |
| What excipients (inactive ingredients) are in GVOKE PFS? | GVOKE PFS excipients list |
| DailyMed Link: | GVOKE PFS at DailyMed |
US Patents and Regulatory Information for GVOKE PFS
GVOKE PFS is protected by two US patents.
Patents protecting GVOKE PFS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEVERE HYPOGLYCEMIA
Methods for producing stable therapeutic formulations in aprotic polar solvents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEVERE HYPOGLYCEMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xeris | GVOKE PFS | glucagon | SOLUTION;SUBCUTANEOUS | 212097-001 | Sep 10, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Xeris | GVOKE PFS | glucagon | SOLUTION;SUBCUTANEOUS | 212097-002 | Sep 10, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Xeris | GVOKE PFS | glucagon | SOLUTION;SUBCUTANEOUS | 212097-001 | Sep 10, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for GVOKE PFS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Tetris Pharma B.V | Ogluo | glucagon | EMEA/H/C/005391 Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. |
Authorised | no | no | no | 2021-02-11 | |
| Eli Lilly Nederland B.V. | Baqsimi | glucagon | EMEA/H/C/003848 Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus. |
Authorised | no | no | no | 2019-12-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for GVOKE PFS
See the table below for patents covering GVOKE PFS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016201248 | ⤷ Sign Up | |
| China | 108135980 | 在非质子极性溶剂中制备稳定的胰高血糖素治疗制剂的方法 (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS) | ⤷ Sign Up |
| China | 115531523 | 在非质子极性溶剂中制备稳定的普兰林肽治疗制剂的方法 (Method for preparing stable pramlintide therapeutic formulations in aprotic polar solvents) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >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 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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