Aclidinium bromide; formoterol fumarate - Generic Drug Details
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What are the generic sources for aclidinium bromide; formoterol fumarate and what is the scope of freedom to operate?
Aclidinium bromide; formoterol fumarate
is the generic ingredient in one branded drug marketed by Covis and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Aclidinium bromide; formoterol fumarate has one hundred and fifty-six patent family members in forty-six countries.
Two suppliers are listed for this compound.
Summary for aclidinium bromide; formoterol fumarate
| International Patents: | 156 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 16 |
| DailyMed Link: | aclidinium bromide; formoterol fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aclidinium bromide; formoterol fumarate
Generic Entry Date for aclidinium bromide; formoterol fumarate*:
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; formoterol fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| QuintilesIMS, Inc. | Phase 4 |
| Maastricht University Medical Center | Phase 4 |
| Center for Integrated Rehabilitation and Organ Failure Horn | Phase 4 |
See all aclidinium bromide; formoterol fumarate clinical trials
Pharmacology for aclidinium bromide; formoterol fumarate
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
US Patents and Regulatory Information for aclidinium bromide; formoterol fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | 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 aclidinium bromide; formoterol fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Covis | DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595-001 | Mar 29, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aclidinium bromide; formoterol fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2016130248 | 新規薬用量および製剤 (NOVEL DOSAGE AND FORMULATION) | ⤷ Try a Trial |
| Australia | 6433000 | ⤷ Try a Trial | |
| Serbia | 54241 | JEDINJENJE ZA INHALACIJU KOJE SADRŽI AKLIDINIJUM ZA LEČENJE HRONIČNE OPSTRUKTIVNE BOLESTI PLUĆA (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE) | ⤷ Try a Trial |
| Poland | 1616592 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aclidinium bromide; formoterol fumarate
| 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 | 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 | 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 | C300573 | Netherlands | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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