Skip to Content

Generic Breo Ellipta Availability

Breo Ellipta is a brand name of fluticasone/vilanterol, approved by the FDA in the following formulation(s):

BREO ELLIPTA (fluticasone furoate; vilanterol trifenatate - powder;inhalation)

  • Manufacturer: GLAXO GRP LTD
    Approval date: May 10, 2013
    Strength(s): 0.1MG/INH;EQ 0.025MG BASE/INH [RLD]
  • Manufacturer: GLAXO GRP LTD
    Approval date: April 30, 2015
    Strength(s): 0.2MG/INH;EQ 0.025MG BASE/INH [RLD]

Has a generic version of Breo Ellipta been approved?

No. There is currently no therapeutically equivalent version of Breo Ellipta available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Breo Ellipta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Inhalation device
    Patent 5,873,360
    Issued: February 23, 1999
    Inventor(s): Davies; Michael Birsha & Hearne; David John & Rand; Paul Kenneth & Walker; Richard Ian
    Assignee(s): Glaxo Group Limited
    An inhalation device is described for use with a medicament pack in which at least one container for medicament in powder form is defined between two sheets peelably secured to one another. The device comprises means for peeling the sheets apart at an opening station to open the container; and an outlet, communicating with the opened container, through which a user can inhale medicament in powder form from the opened container.
    Patent expiration dates:
    • February 23, 2016
      ✓ 
      Drug product
  • Anti-inflammatory androstane derivatives
    Patent 6,537,983
    Issued: March 25, 2003
    Inventor(s): Keith; Biggadike & Paul Spencer; Jones & Jeremy John; Payne
    Assignee(s): SmithKline Beecham Corporation
    According to one aspect of the invention, there is provided a pharmaceutical formulation for administration by inhalation comprising a compound of formula (I), wherein R1 represents C1-6 alkyl or C1-6 haloalkyl; R2 represents —C(═O)-aryl or —C(═O)-heteroaryl; R3 represents hydrogen, methyl (which may be in either the &agr; or &bgr; configuration) or methylene; R4 and R5 are the same or different and each represents hydrogen or halogen; and {overscore (-----)} represents a single or a double bond; and salts and solvates thereof together with a long-acting &bgr;2-adrenoreceptor agonist which formulation has a therapeutically useful effect in the treatment of inflammatory disorders of the respiratory tract over a period of 24 hours or more.
    Patent expiration dates:
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug product
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug product
  • Anti-inflammatory androstane derivative
    Patent 6,759,398
    Issued: July 6, 2004
    Inventor(s): Keith; Biggadike
    Assignee(s): SmithKline Beecham Corporation
    According to one aspect of the invention, there is provided a pharmaceutical formulation for administration by inhalation comprising a compound of formula (I), or a solvate thereof, together with a long-acting &bgr;2-adrenoreceptor agonist which formulation has a therapeutically useful effect in the treatment of inflammatory disorders of the respiratory tract over a period of 24 hours or more.
    Patent expiration dates:
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug product
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug product
  • Anti-inflammatory androstane derivatives
    Patent 6,878,698
    Issued: April 12, 2005
    Inventor(s): Biggadike; Keith & Jones; Paul Spencer & Payne; Jeremy John
    Assignee(s): Glaxo Group Limited
    According to one aspect of the invention, there is provided a pharmaceutical formulation for administration by inhalation comprising a compound of formula (I), wherein R1 represents C1-6 alkyl or C1-6 haloalkyl; R2 represents —C(═O)-aryl or —C(═O)-heteroaryl; R3 represents hydrogen, methyl (which may be in either the α or β configuration) or methylene; R4 and R5 are the same or different and each represents hydrogen or halogen; and represents a single or a double bond; and salts and solvates thereof together with a long-acting β2-adrenoreceptor agonist which formulation has a therapeutically useful effect in the treatment of COPD over a period of 24 hours or more.
    Patent expiration dates:
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
  • Anti-inflammatory androstane derivative
    Patent 7,101,866
    Issued: September 5, 2006
    Inventor(s): Biggadike; Keith & Coote; Steven John & Nice; Rosalyn Kay
    Assignee(s): Glaxo Group Limited
    According to one aspect of the invention, there is provided a compound of formula (I) and solvates thereof. There are also provided compositions containing the compound, processes for preparing it, and its use in therapy.
    Patent expiration dates:
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 3, 2021
      ✓ 
      Patent use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Phenethanolamine derivatives for treatment of respiratory diseases
    Patent 7,439,393
    Issued: October 21, 2008
    Inventor(s): Box; Philip Charles & Coe; Diane Mary & Looker; Brian Edgar & Mann; Inderjit Singh & Procopiou; Panayiotis Alexandrou
    Assignee(s): Glaxo Group Limited
    The invention relates to 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol; and salts and solvates thereof, including those which are pharmaceutically acceptable, along with formulations thereof, combinations thereof, and methods for the treatment or prophylaxis of mammals by administering such compounds.
    Patent expiration dates:
    • September 11, 2022
      ✓ 
      Patent use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 11, 2022
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Anti-inflammatory androstane derivative
    Patent 7,629,335
    Issued: December 8, 2009
    Inventor(s): Biggadike; Keith & Coote; Steven John & Nice; Rosalyn Kay
    Assignee(s): Glaxo Group Limited
    According to one aspect of the invention, there is provided a compound of formula (I) and solvates thereof. There are also provided compositions containing the compound, processes for preparing it, and its use in therapy.
    Patent expiration dates:
    • August 3, 2021
      ✓ 
      Drug product
  • Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
    Patent 7,776,895
    Issued: August 17, 2010
    Inventor(s): Box; Philip Charles & Coe; Diane Mary & Looker; Brian Edgar & Mann; Inderjit Singh & Procopiou; Panayiotis Alexandrou
    Assignee(s): Glaxo Group Limited
    The invention provides inhalation devices comprising a compound which is 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol; or a salt or solvate thereof, inhalation devices comprising formulations and combinations of the compound or a salt or solvate thereof, and methods for the treatment or prophylaxis of a clinical condition in a mammal by employing the inhalation devices.
    Patent expiration dates:
    • September 11, 2022
      ✓ 
      Drug product
  • Counter for use with a medicament dispenser
    Patent 8,113,199
    Issued: February 14, 2012
    Inventor(s): Augustyn; Stephen Edward & Harvey; Stephen James
    Assignee(s): Glaxo Group Limited
    There is provided a dose counter for use with a medicament dispenser. The dose counter comprises a first count wheel arranged to rotate about a first axis of rotation, the first count wheel including a set of primary drive teeth arranged annularly thereon for drivable rotation of the first count wheel about the first axis of rotation; a second count wheel arranged to rotate about the first axis of rotation, the second count wheel including a set of secondary drive teeth arranged annularly thereon; and a kick wheel arranged to rotate about a second axis of rotation offset from the first axis of rotation, the kick wheel including a set of kick teeth arranged annularly thereon and in meshed relationship with the set of secondary drive teeth of the second count wheel such that rotary motion of the kick wheel results in rotary motion of the second count wheel. The first count wheel further includes a fixed index tooth arranged for intermittent meshing with the kick teeth of the kick wheel such that rotary motion of the kick wheel results from rotary motion of the first count wheel only when the intermittent meshing occurs.
    Patent expiration dates:
    • October 23, 2027
      ✓ 
      Drug product
  • Medicament dispenser
    Patent 8,161,968
    Issued: April 24, 2012
    Inventor(s): Augustyn; Stephen & Davies; Michael Birsha & Harvey; Stephen James & Rand; Paul Kenneth
    Assignee(s): Glaxo Group Limited
    There is provided a medicament dispenser for containing plural elongate form medicament carriers, each having multiple distinct medicament dose portions carried thereby, the dispenser having a housing of generally non-circular form, and within said housing a dispensing mechanism for dispensing the distinct medicament dose portions carried by each of said plural medicament carriers. The mechanism comprises at least one receiving station for receiving each of the plural medicament carriers; a release for releasing in combination a distinct medicament dose portion from each of the plural medicament carriers on receipt thereof by said receiving station; an outlet, positioned to be in communication with the distinct medicament dose portions releasable by said release; and at least one indexer for individually indexing the distinct medicament dose portions of each of the plural medicament carriers. The dispenser contains plural elongate form medicament carriers, each having multiple distinct dose portions carried thereby. At least one of said medicament carriers has the form of a continuous loop.
    Patent expiration dates:
    • February 5, 2028
      ✓ 
      Drug product
  • Medicament dispenser
    Patent 8,511,304
    Issued: August 20, 2013
    Assignee(s): Glaxo Group Limited
    There is provided a medicament dispenser for use with plural elongate form medicament carriers, each having multiple distinct medicament dose portions carried thereby, the dispenser having a dispensing mechanism for dispensing the distinct medicament dose portions carried by each of the plural medicament carriers. The mechanism comprises a receiving station for receiving each of the plural medicament carriers; a release for releasing a distinct medicament dose portion from each of the plural medicament carriers on receipt thereof by the receiving station; an outlet, positioned to be in communication with the distinct medicament dose portions releasable by said a release; and an indexer for individually indexing the distinct medicament dose portions of each of the plural medicament carriers.
    Patent expiration dates:
    • June 14, 2027
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug product
    • June 14, 2027
      ✓ 
      Patent use: LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSOTO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug product
  • Manifold for use in medicament dispenser
    Patent 8,534,281
    Issued: September 17, 2013
    Assignee(s): Glaxo Group Limited
    A manifold for use in a medicament dispenser device for the delivery of medicament powder from an open blister pocket of a blister pack comprises a body, the body defining a chimney having a chimney inlet and a chimney exit for directing airflow from said chimney inlet to the chimney exit; the body further defining a chamber having a chamber inlet and a chamber exit, wherein the chimney exit and the chamber inlet lie side-by-side each other such that when the open blister pocket of the blister pack is positioned adjacent thereto the airflow is directed from the chimney exit to the chamber inlet via the open blister pocket to entrain the medicament powder and enable transport thereof in the airflow from the chamber inlet to the chamber exit, and wherein one or more bleed holes are provided between the chimney and the chamber such that bleed airflow is able to be directed into the chamber to disruptively impact the airflow that transports the entrained medicament powder.
    Patent expiration dates:
    • August 10, 2029
      ✓ 
      Drug product
  • Medicament dispenser
    Patent 8,746,242
    Issued: June 10, 2014
    Assignee(s): Glaxo Group Limited
    A medicament dispenser for use with at least one medicament carrier carrying multiple distinct medicament portions, said medicament dispenser comprising (a) a dispensing mechanism actuable for dispensing the distinct medicament portions carried by the at least one medicament carrier; (b) a mouthpiece; and (c) a cover for the mouthpiece, the cover being movably mounted to the dispenser for sequential movement from a first position, in which the mouthpiece is covered, to a second position, in which the mouthpiece is at least part-uncovered, to a third position in which the mouthpiece is uncovered; wherein the cover is adapted to couple with the dispensing mechanism such that movement of the cover from the second position to the third position, but not the first position to the second position, results in actuation of the dispensing mechanism.
    Patent expiration dates:
    • October 11, 2030
      ✓ 
      Drug product
  • Medicament dispenser
    Patent 9,333,310
    Issued: May 10, 2016
    Assignee(s): Glaxo Group Limited
    A sheet driver for use in a medicament dispenser with blister pockets includes: (a) a base, extending from the base, (b) a shaft defining a rotational axis; at the base, (c) a drive surface for receipt of drive to rotate the base about the rotational axis; about the shaft, (d) a torsion spring defining first and second spring legs; mounting about the shaft and the torsion spring for rotation about the rotational axis, and (e) a hub defining a hub surface for receipt of a sheet of the medicament carrier, the hub surface being adapted to provide an initial effective winding surface which provides uniform indexing of the medicament carrier.
    Patent expiration dates:
    • October 2, 2027
      ✓ 
      Drug product
  • Phenethanolamine derivatives for treatment of respiratory diseases
    Patent RE44874
    Issued: April 29, 2014
    Assignee(s): Glaxo Group Limited
    The present invention relates to novel compounds of formula (I), to a process for their manufacture, to pharmaceutical compositions containing them, and to their use in therapy, in particular their use in the prophylaxis and treatment of respiratory diseases
    Patent expiration dates:
    • March 23, 2023
      ✓ 
      Patent use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 23, 2023
      ✓ 
      Patent use: FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 10, 2016 - NEW PRODUCT
    • April 30, 2018 - NEW PRODUCT
    • April 30, 2018 - DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
Hide