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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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
*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 ⤷ 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 TUDORZA PRESSAIR
Dosage and formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Dosage and formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Quinuclidine derivatives and their use as muscarinic M3 receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Japan | 6170460 | ⤷ Sign Up | |
| Israel | 271132 | תכשיר ומינון חדשים (Novel dosage and formulation) | ⤷ Sign Up |
| Portugal | 2265257 | ⤷ Sign Up | |
| Turkey | 9701665 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TUDORZA PRESSAIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1200431 | SPC/GB13/006 | United Kingdom | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 132013902117495 | Italy | ⤷ Sign Up | PRODUCT NAME: BROMURO DI ACLIDINIO(EKLIRA GENUAIR E BRETARIS GENUAIR); AUTHORISATION NUMBER(S) AND DATE(S): BRETARIS G.: EU/1/12/781/001-002-003; EKLIRA G.:EU/1/12/778/001-002-003, 20120720 |
| 1200431 | C300573 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720 |
| >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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