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Generic Myrbetriq Availability

Last updated on July 7, 2021.

Myrbetriq is a brand name of mirabegron, approved by the FDA in the following formulation(s):

MYRBETRIQ (mirabegron - tablet, extended release;oral)

  • Manufacturer: APGDI
    Approval date: June 28, 2012
    Strength(s): 25MG [RLD], 50MG [RLD]

Has a generic version of Myrbetriq been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Myrbetriq. 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: Generic Drug FAQ.

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.

  • Patent 10,842,780

    Patent expiration dates:

    • September 28, 2029
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      Patent use: ADMINISTRATION OF AN EXTENDED RELEASE TABLET FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
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      Drug product
  • Patent 10842780*

    Patent expiration dates:

    • March 28, 2030
  • Amide derivatives or salts thereof
    Patent 6,346,532
    Issued: February 12, 2002
    Inventor(s): Tatsuya; Maruyama & Takayuki; Suzuki & Kenichi; Onda & Masahiko; Hayakawa & Hiroyuki; Moritomo & Tetsuya; Kimizuka & Tetsuo; Matsui
    Assignee(s): Yamanouchi Pharmaceutical Co., Ltd.

    Amide derivatives represented by general formula (I) or salts thereof wherein each symbol has the following meaning: ring B: an optionally substituted heteroaryl optionally fused with a benzene ring; X: a bond, lower alkylene or lower alkenylene optionally substituted by hydroxy or lower alkyl, carbonyl, or a group represented by —NH— (when X is lower alkylene optionally substituted by lower alkyl which may be bonded to the hydrogen atom bonded to a constituent carbon atom of ring B to form lower alkylene to thereby form a ring); A: a lower alkylene or a group represented by -(lower alkylene)—O—; R1a and R1b: the same or different and each hydrogen or lower alkyl; R2: hydrogen or halogeno; and Z: nitrogen or a group represented by ═CH—. The compounds are useful as a diabetes remedy which not only functions to both accelerate the secretion of insulin and enhance insulin sensitivity but has an antiobestic action and an antihyperlipemic action based on its selective stimulative action on a &bgr;3 receptor.

    Patent expiration dates:

    • March 27, 2022
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      Drug substance
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      Drug product
    • September 27, 2022
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      Pediatric exclusivity
  • α-form or β-form crystal of acetanilide derivative
    Patent 7,342,117
    Issued: March 11, 2008
    Inventor(s): Kawazoe; Souichirou & Sakamoto; Kenichirou & Awamura; Yuji & Maruyama; Tatsuya & Suzuki; Takayuki & Onda; Kenichi & Takasu; Toshiyuki
    Assignee(s): Astellas Pharma Inc.

    To provide novel crystals useful as an ingredient for the production of a diabetes remedy. The invention is concerned with α-form crystal and β-form crystal of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenyleth-yl)amino]ethyl]acetanilide. The α-form crystal does not exhibit hygroscopicity and has stability such that it can be used as a medicine, and is useful for mass synthesis in the industrial production. The β-form crystal does not relatively exhibit hygroscopicity and is also useful as a production intermediate of the α-form crystal.

    Patent expiration dates:

    • November 4, 2023
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      Drug substance
    • May 4, 2024
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      Pediatric exclusivity
  • α-form or β-form crystal of acetanilide derivative
    Patent 7,982,049
    Issued: July 19, 2011
    Inventor(s): Kawazoe; Souichirou & Sakamoto; Kenichirou & Awamura; Yuji & Maruyama; Tatsuya & Suzuki; Takayuki & Onda; Kenichi & Takasu; Toshiyuki
    Assignee(s): Astellas Pharma Inc.

    To provide novel crystals useful as an ingredient for the production of a diabetes remedy. The invention is concerned with α-form crystal and β-form crystal of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetanilide. The α-form crystal does not exhibit hygroscopicity and has stability such that it can be used as a medicine, and is useful for mass synthesis in the industrial production. The β-form crystal does not relatively exhibit hygroscopicity and is also useful as a production intermediate of the α-form crystal.

    Patent expiration dates:

    • November 4, 2023
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      Drug product
    • May 4, 2024
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      Pediatric exclusivity
  • Pharmaceutical composition for treating overactive bladder
    Patent 8,772,315
    Issued: July 8, 2014
    Assignee(s): Astellas Pharma Inc.

    A pharmaceutical composition comprising (R)-2-(2-aminothiazol-4-yl)-4′-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}acetanilide or a pharmaceutically acceptable salt thereof and (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof, as active ingredients, in particular for improving various symptoms accompanying overactive bladder, such as urinary urgency, pollakiuria and/or urinary incontinence.

    Patent expiration dates:

    • October 30, 2028
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      Patent use: USE IN COMBINATION WITH THE MUSCARINIC ANTAGONIST SOLIFENACIN SUCCINATE FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
    • April 30, 2029
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      Pediatric exclusivity
  • Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
    Patent 8,835,474
    Issued: September 16, 2014
    Assignee(s): Astellas Pharma Inc.

    (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide or its salt shows a potent bladder relaxation effect in “isolated rat bladder smooth muscle relaxation test”, dose-dependently lowers the contraction frequency of rhythmic bladder contractions in “rat rhythmic bladder contraction measurement test” and, moreover, prolongs the urination intervals in “urination functions measurement test on cyclophosphamide-induced overactive bladder model rat”. Owing to these effects, the above compound is useful as a remedy for overactive bladder.

    Patent expiration dates:

    • November 4, 2023
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      Patent use: FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
    • May 4, 2024
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      Pediatric exclusivity
  • Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
    Patent RE44872
    Issued: April 29, 2014
    Assignee(s): Astellas Pharma Inc.

    (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide or its salt shows a potent bladder relaxation effect in “isolated rat bladder smooth muscle relaxation test”, dose-dependently lowers the contraction frequency of rhythmic bladder contractions in “rat rhythmic bladder contraction measurement test” and, moreover, prolongs the urination intervals in “urination functions measurement test on cyclophosphamide-induced overactive bladder model rat”. Owing to these effects, the above compound is useful as a remedy for ovaractive bladder.

    Patent expiration dates:

    • November 4, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
    • May 4, 2024
      ✓ 
      Pediatric exclusivity

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:

    • April 27, 2021 - CO-ADMINISTRATION THERAPY OF MIRABEGRON WITH SOLIFENACIN SUCCINATE FOR TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
    • March 25, 2024 - TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
    • September 25, 2024 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.