INCRUSE ELLIPTA Drug Patent Profile
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When do Incruse Ellipta patents expire, and what generic alternatives are available?
Incruse Ellipta is a drug marketed by Glaxo Grp England and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-seven countries.
The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.
DrugPatentWatch® Generic Entry Outlook for Incruse Ellipta
Incruse Ellipta was eligible for patent challenges on December 18, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 18, 2027. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for INCRUSE ELLIPTA?
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Summary for INCRUSE ELLIPTA
International Patents: | 108 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Patent Applications: | 289 |
Drug Prices: | Drug price information for INCRUSE ELLIPTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INCRUSE ELLIPTA |
What excipients (inactive ingredients) are in INCRUSE ELLIPTA? | INCRUSE ELLIPTA excipients list |
DailyMed Link: | INCRUSE ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INCRUSE ELLIPTA
Generic Entry Date for INCRUSE ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION |
*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.
Pharmacology for INCRUSE ELLIPTA
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for INCRUSE ELLIPTA
INCRUSE ELLIPTA is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INCRUSE ELLIPTA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting INCRUSE ELLIPTA
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Expired US Patents for INCRUSE ELLIPTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for INCRUSE ELLIPTA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
GlaxoSmithKline (Ireland) Limited | Incruse Ellipta (previously Incruse) | umeclidinium bromide | EMEA/H/C/002809 Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)., |
Authorised | no | no | no | 2014-04-28 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for INCRUSE ELLIPTA
See the table below for patents covering INCRUSE ELLIPTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E028513 | ⤷ Sign Up | |
South Korea | 20110010841 | MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS | ⤷ Sign Up |
Hungary | 213221 | INHALATION DEVICE AND MEDICINE PACKET FOR DEVICE | ⤷ Sign Up |
Australia | 2005237576 | Muscarinic Acetylcholine Receptor Antagonists | ⤷ Sign Up |
South Korea | 20130102134 | MEDICAMENT DISPENSER | ⤷ Sign Up |
Canada | 2533333 | DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER) | ⤷ Sign Up |
Norway | 20065417 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INCRUSE ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1740177 | 14C0075 | France | ⤷ Sign Up | PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428 |
2506844 | 23/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: EIN PHARMAZEUTISCHES KOMBINATIONSPRODUKT, UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM, VILANTEROL ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON UND FLUTICASONFUROAT; REGISTRATION NO/DATE: EU/1/17/1236 (MITTEILUNG) 20171117 |
1740177 | CA 2014 00052 | Denmark | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428 |
2506844 | SPC/GB18/020 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117 |
1740177 | C01740177/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014 |
1740177 | SPC/GB14/055 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUM BROMIDE (ALSO REFERRED TO AS 4-(HYDROXY(DIPHENYL)METHYL)-1-(2-((PHENYLMETHYL)OXY)ETHYL)-1-AZONIABICYCLO(2.2.2)OCTANE BROMIDE); REGISTERED: UK EU/1/14/922/001 20140430; UK EU/1/14/922/002 20140430; UK EU/1/14/922/003 20140430 |
1740177 | PA2014038 | Lithuania | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |