GLUCAGON - Generic Drug Details
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What are the generic sources for glucagon and what is the scope of freedom to operate?
Glucagon
is the generic ingredient in six branded drugs marketed by Amphastar Pharms Inc, Lilly, Xeris, Novo Nordisk, and Fresenius Kabi Usa, and is included in seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Glucagon has one hundred and seven patent family members in forty-two countries.
There are twelve drug master file entries for glucagon. Four suppliers are listed for this compound.
Summary for GLUCAGON
International Patents: | 107 |
US Patents: | 5 |
Tradenames: | 6 |
Applicants: | 5 |
NDAs: | 7 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 823 |
Patent Applications: | 7,015 |
Drug Prices: | Drug price trends for GLUCAGON |
What excipients (inactive ingredients) are in GLUCAGON? | GLUCAGON excipients list |
DailyMed Link: | GLUCAGON at DailyMed |
Recent Clinical Trials for GLUCAGON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pichamol Jirapinyo, MD, MPH | Phase 4 |
National Center for Advancing Translational Sciences (NCATS) | Early Phase 1 |
Ain Shams University | N/A |
Pharmacology for GLUCAGON
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 | |||
Novo Nordisk | GLUCAGEN | glucagon hydrochloride | POWDER;INTRAMUSCULAR, INTRAVENOUS | 020918-001 | Jun 22, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Kabi Usa | GLUCAGON | glucagon hydrochloride | POWDER;INTRAMUSCULAR, INTRAVENOUS | 201849-001 | May 8, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Lilly | GLUCAGON | glucagon hydrochloride | INJECTABLE;INJECTION | 012122-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 HYPOPEN | glucagon | SOLUTION;SUBCUTANEOUS | 212097-004 | Sep 10, 2019 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for GLUCAGON
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amphastar Pharms Inc | BAQSIMI | glucagon | POWDER;NASAL | 210134-001 | Jul 24, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for GLUCAGON
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 GLUCAGON
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 102449080 | ⤷ Sign Up | |
Mexico | 2021011846 | SISTEMAS Y METODOS DE ADMINISTRACION DE MEDICAMENTOS. (MEDICATION DELIVERY SYSTEMS AND METHODS.) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2017220879 | ⤷ Sign Up | |
Moldova, Republic of | 3258919 | ⤷ Sign Up | |
Japan | 7094242 | ⤷ Sign Up | |
Australia | 2019438995 | Medication delivery systems and methods | ⤷ Sign Up |
Canada | 2999404 | METHODES DE PRODUCTION DE FORMULATIONS THERAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTI C POLAR SOLVENTS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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