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. Two suppliers are 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: | 2 |
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 |
Center for Integrated Rehabilitation and Organ Failure Horn | Phase 4 |
Pharmacology for aclidinium bromide
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for aclidinium bromide
Expired US Patents for aclidinium bromide
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 |
---|---|---|---|
Brazil | PI0513360 | inalador para a administração de produtos farmacêuticos em pó, e um sistema de cartucho de pó para uso com esse inalador | ⤷ Try a Trial |
Australia | 2005263486 | Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler | ⤷ Try a Trial |
Russian Federation | 2005121162 | ⤷ Try a Trial | |
Portugal | 2265257 | ⤷ Try a Trial | |
China | 1824664 | ⤷ Try a Trial | |
New Zealand | 552523 | Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler | ⤷ Try a Trial |
Poland | 1616592 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aclidinium bromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1200431 | 2013C/001 | Belgium | ⤷ Try a 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 | 421 | Finland | ⤷ Try a Trial | |
1200431 | 2013/002 | Ireland | ⤷ Try a 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 | C 2013 002 | Romania | ⤷ Try a Trial | PRODUCT NAME: SAREDE ACLIDINIU CU UN ANION ACCEPTABIL FARMACEUTIC AL UNUI ACID MONO SAU POLIVALENT, IN SPECIAL BROMURA DEACLIDINIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/778/001, RO EU/1/12/778/002, RO EU/1/12/778/003; DATE OF NATIONAL AUTHORISATION: 20120720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/778/001, EMEA EU/1/12/778/002, EMEA EU/1/12/778/003; DATE OF FIRST AUTHORISATION IN EEA: 20120720 |
1200431 | 132013902117495 | Italy | ⤷ Try a Trial | 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 | C01200431/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013 |
1200431 | 1390002-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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