INCRUSE ELLIPTA Drug Patent Profile
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Which patents cover Incruse Ellipta, 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 seven 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
Summary for INCRUSE ELLIPTA
| International Patents: | 107 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Patent Applications: | 335 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for INCRUSE ELLIPTA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005014089 | ⤷ Try a Trial | |
| Japan | 2008509766 | ⤷ Try a Trial | |
| Norway | 338541 | ⤷ Try a Trial | |
| Japan | 4825138 | ⤷ Try a Trial | |
| Finland | 990115 | ⤷ Try a Trial | |
| Germany | 602004031119 | ⤷ Try a Trial | |
| Hong Kong | 1106169 | 藥劑分配器 (MEDICAMENT DISPENSER) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INCRUSE ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1740177 | 300694 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430 |
| 2506844 | 1890025-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
| 1740177 | C20140032 00132 | Estonia | ⤷ Try a Trial | PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014 |
| 2506844 | CA 2018 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117 |
| 1740177 | C 2014 041 | Romania | ⤷ Try a Trial | PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428 |
| 1740177 | C01740177/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014 |
| 1740177 | SPC/GB14/055 | United Kingdom | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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