Aclidinium bromide - Generic Drug Details
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What are the generic drug sources for aclidinium bromide and what is the scope of patent protection?
Aclidinium bromide
is the generic ingredient in two branded drugs marketed by Covis and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aclidinium bromide has one hundred and fifty-six patent family members in forty-six countries.
There is one drug master file entry for aclidinium bromide. One supplier is listed for this compound.
Summary for aclidinium bromide
International Patents: | 156 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 39 |
Patent Applications: | 783 |
What excipients (inactive ingredients) are in aclidinium bromide? | aclidinium bromide excipients list |
DailyMed Link: | aclidinium bromide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aclidinium bromide
Generic Entry Date for aclidinium bromide*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for aclidinium bromide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AstraZeneca | Phase 1 |
QuintilesIMS, Inc. | Phase 4 |
Maastricht University Medical Center | Phase 4 |
Pharmacology for aclidinium bromide
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for aclidinium bromide
US Patents and Regulatory Information for aclidinium bromide
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 | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | 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 | |||
Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | 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 aclidinium bromide
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 |
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 aclidinium bromide
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 aclidinium bromide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1373760 | ⤷ Sign Up | |
European Patent Office | 2265257 | ⤷ Sign Up | |
Austria | 235492 | ⤷ Sign Up | |
Montenegro | 02286 | JEDINJENJE ZA INHALACIJU KOJE SADRŽI AKLIDINIJUM ZA LEČENJE HRONIČNE OPSTRUKTIVNE BOLESTI PLUĆA (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE) | ⤷ Sign Up |
Russian Federation | 2608713 | НОВАЯ ДОЗА И ПРЕПАРАТИВНАЯ ФОРМА (NEW DOSE AND FORMULATION) | ⤷ Sign Up |
Slovakia | 432002 | Novel quinuclidine derivatives and medicinal compositions containing the same | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aclidinium bromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
1200431 | C01200431/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013 |
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 | 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 | PA2013001,C1200431 | Lithuania | ⤷ Sign Up | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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