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 ten patents protecting this drug.
This drug has one hundred and seventy-seven patent family members in thirty-nine 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.
Indicators of Generic Entry
Summary for INCRUSE ELLIPTA
| International Patents: | 177 |
| US Patents: | 10 |
| 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 |
| 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 ten 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
Counter for use with a medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
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.
Manifold for use in medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | 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 |
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
When does loss-of-exclusivity occur for INCRUSE ELLIPTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 13
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 0902
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 05237576
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0510170
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 64742
Estimated Expiration: ⤷ Try a Trial
Patent: 55954
Estimated Expiration: ⤷ Try a Trial
China
Patent: 76701
Estimated Expiration: ⤷ Try a Trial
Patent: 2040602
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120832
Estimated Expiration: ⤷ Try a Trial
Patent: 0161385
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13196
Estimated Expiration: ⤷ Try a Trial
Patent: 18082
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 40177
Estimated Expiration: ⤷ Try a Trial
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 066940
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 5033
Estimated Expiration: ⤷ Try a Trial
Patent: 1994
Estimated Expiration: ⤷ Try a Trial
Patent: 0601991
Estimated Expiration: ⤷ Try a Trial
Patent: 1100019
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 40177
Estimated Expiration: ⤷ Try a Trial
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
Patent: 11936
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 02423
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 31304
Estimated Expiration: ⤷ Try a Trial
Patent: 400053
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8152
Patent: 4-[HYDROXY(DIPHENYL)METHYL]-1-{2-[PHENYLMETHYL)OXY]ETHYL}-1-AZONIABICYCLO[2.2.2] OCTANE BROMIDE USEFUL FOR TREATING MUSCARINIC ACETYLCHOLINE RECEPTOR MEDIATED DISEASES, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 14121
Estimated Expiration: ⤷ Try a Trial
Patent: 98871
Estimated Expiration: ⤷ Try a Trial
Patent: 07534769
Estimated Expiration: ⤷ Try a Trial
Patent: 12162559
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 565
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4753
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06012405
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 631
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0694
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9997
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 8959
Estimated Expiration: ⤷ Try a Trial
Patent: 17017
Estimated Expiration: ⤷ Try a Trial
Patent: 17018
Estimated Expiration: ⤷ Try a Trial
Patent: 065417
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060259
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 40177
Estimated Expiration: ⤷ Try a Trial
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 40177
Estimated Expiration: ⤷ Try a Trial
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 6597
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 40177
Estimated Expiration: ⤷ Try a Trial
Patent: 70128
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0608565
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1037026
Estimated Expiration: ⤷ Try a Trial
Patent: 1152032
Estimated Expiration: ⤷ Try a Trial
Patent: 070015412
Estimated Expiration: ⤷ Try a Trial
Patent: 110010841
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 92848
Estimated Expiration: ⤷ Try a Trial
Patent: 00405
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 63759
Estimated Expiration: ⤷ Try a Trial
Patent: 0605887
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 768
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 871
Estimated Expiration: ⤷ 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.
See the table below for additional patents covering INCRUSE ELLIPTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Switzerland | 683319 | Inhalationsvorrichtung. | ⤷ Try a Trial |
| South Korea | 20080080636 | MANIFOLD FOR USE IN MEDICAMENT DISPENSER | ⤷ Try a Trial |
| Hong Kong | 19195 | Medicament pack | ⤷ Try a Trial |
| Italy | 1244655 | DISPOSITIVO PER INALAZIONE. | ⤷ Try a Trial |
| Sweden | 512934 | Inhalationsanordning | ⤷ Try a Trial |
| South Korea | 20110010841 | MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS | ⤷ 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 | 122014000096 | Germany | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428 |
| 2506844 | 18C1022 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| 1740177 | 58/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430 |
| 1740177 | 14C0075 | France | ⤷ Try a Trial | PRODUCT NAME: BROMURE D'UMECLIDINIUM; REGISTRATION NO/DATE: EU/1/14/922 001-003 20140428 |
| 1740177 | CA 2014 00052 | Denmark | ⤷ Try a Trial | PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428 |
| 1740177 | 1490060-9 | Sweden | ⤷ Try a Trial | MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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