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Generic Myrbetriq Availability

Last updated on Nov 8, 2022.

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] [AB], 50MG [RLD] [AB]

MYRBETRIQ GRANULES (mirabegron - for suspension, extended release;oral)

  • Manufacturer: APGDI
    Approval date: March 25, 2021
    Strength(s): 8MG/ML [RLD]

Has a generic version of Myrbetriq been approved?

A generic version of Myrbetriq has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Myrbetriq and have been approved by the FDA:

mirabegron tablet, extended release;oral

  • Manufacturer: LUPIN LTD
    Approval date: September 28, 2022
    Strength(s): 25MG [AB], 50MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: September 29, 2022
    Strength(s): 25MG [AB], 50MG [AB]

Note: No generic formulation of the following product is available.

  • mirabegron - for suspension, extended release;oral

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.

  • Pharmaceutical composition containing mirabegron
    Patent 10,058,536
    Issued: August 28, 2018
    Assignee(s): ASTELLAS PHARMA INC.

    To provide: (1) a modified release liquid (suspension) containing mirabegron, (2) a ready-to-suspend pharmaceutical composition containing mirabegron, and (3) a mirabegron-containing pharmaceutical composition that does not generate undissolved lumps, even when it is suspended at the time of use. The present invention relates to a pharmaceutical composition containing a complex of mirabegron or a pharmaceutically acceptable salt thereof with sodium polystyrene sulfonate.

    Patent expiration dates:

    • March 31, 2036
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      Patent use: TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS AGED 3 YEARS AND OLDER BY ADMINISTRATION OF AN EXTENDED-RELEASE SUSPENSION FORMULATION OF MIRABEGRON
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      Drug product
  • Patent 10058536*

    Patent expiration dates:

    • October 1, 2036
  • 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
    • 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
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      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:

    • March 25, 2024 - NEW PRODUCT
    • 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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