TUDORZA PRESSAIR Drug Patent Profile
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Which patents cover Tudorza Pressair, and when can generic versions of Tudorza Pressair launch?
Tudorza Pressair is a drug marketed by Covis and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and fifty-six patent family members in forty-six countries.
The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide profile page.
DrugPatentWatch® Generic Entry Outlook for Tudorza Pressair
Tudorza Pressair was eligible for patent challenges on July 23, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 10, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
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Summary for TUDORZA PRESSAIR
International Patents: | 156 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Patent Applications: | 377 |
Drug Prices: | Drug price information for TUDORZA PRESSAIR |
What excipients (inactive ingredients) are in TUDORZA PRESSAIR? | TUDORZA PRESSAIR excipients list |
DailyMed Link: | TUDORZA PRESSAIR at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TUDORZA PRESSAIR
Generic Entry Date for TUDORZA PRESSAIR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER, METERED;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 TUDORZA PRESSAIR
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for TUDORZA PRESSAIR
TUDORZA PRESSAIR is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUDORZA PRESSAIR is ⤷ Free Trial.
This potential generic entry date is based on patent ⤷ Free 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.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free Trial | |||
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free Trial | |||
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | Y | ⤷ Free Trial | ||
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free 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 TUDORZA PRESSAIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Free Trial | ⤷ Free Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TUDORZA PRESSAIR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Covis Pharma Europe B.V. | Bretaris Genuair | aclidinium bromide | EMEA/H/C/002706 Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
Authorised | no | no | no | 2012-07-20 | |
Covis Pharma Europe B.V. | Eklira Genuair | aclidinium bromide | EMEA/H/C/002211 Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
Authorised | no | no | no | 2012-07-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TUDORZA PRESSAIR
See the table below for patents covering TUDORZA PRESSAIR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 602005023690 | ⤷ Free Trial | |
Canada | 2225396 | CARTOUCHE DE POUDRE PHARMACEUTIQUE AVEC APPAREIL DE DOSAGE INTEGRE ET INHALATEUR POUR MEDICAMENTS EN POUDRE (PHARMACEUTICAL POWDER CARTRIDGE WITH INTEGRATED METERING DEVICE AND INHALER FOR POWDERED MEDICAMENTS) | ⤷ Free Trial |
European Patent Office | 1200431 | DERIVES DE QUINUCLIDINE ET LEUR UTILISATION COMME LIGANDS DES RECEPTEURS M3 MUSCARINIQUES (QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC M3 RECEPTORS LIGANDS) | ⤷ Free Trial |
Denmark | 1616592 | ⤷ Free Trial | |
Russian Federation | 2005121162 | ⤷ Free Trial | |
Poland | 204024 | ⤷ Free Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TUDORZA PRESSAIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1200431 | 1390002-2 | Sweden | ⤷ Free Trial | PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720 |
1200431 | 2013/002 | Ireland | ⤷ Free Trial | PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720 |
1200431 | SPC/GB13/006 | United Kingdom | ⤷ Free Trial | PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720 |
1200431 | 2013C/001 | Belgium | ⤷ Free Trial | PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725 |
1200431 | PA2013001 | Lithuania | ⤷ Free Trial | PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720 |
1200431 | 1/2013 | Austria | ⤷ Free Trial | PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for TUDORZA PRESSAIR
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