Generic Myrbetriq Availability
Last updated on Oct 9, 2024.
Myrbetriq is a brand name of mirabegron, approved by the FDA in the following formulation(s):
MYRBETRIQ (mirabegron - tablet, extended release;oral)
MYRBETRIQ GRANULES (mirabegron - for suspension, extended release;oral)
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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
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Manufacturer: ALKEM LABS LTD
Approval date: February 12, 2024
Strength(s): 25MG [AB], 50MG [AB] -
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.
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Pharmaceutical composition containing mirabegron
Patent 10,058,536
Issued: August 28, 2018
Inventor(s): Takae Seiji & Sakai Toshiro & Kasashima Yuki & Ansei Yurina & Kiyota Tsuyoshi
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✓✓
- March 31, 2036
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Pharmaceutical composition containing mirabegron
Patent 10058536*PE
Issued: August 28, 2018
Inventor(s): Takae Seiji & Sakai Toshiro & Kasashima Yuki & Ansei Yurina & Kiyota Tsuyoshi
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:
- October 1, 2036
- October 1, 2036
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Pharmaceutical composition for modified release
Patent 10,842,780
Issued: November 24, 2020
Inventor(s): Takaishi Yuuki & Takahashi Yutaka & Nishizato Takashi & Murayama Daisuke & Murayama Emiko & Nakamura Soichiro & Sako Kazuhiro
Assignee(s): ASTELLAS PHARMA INC.A pharmaceutical composition for modified release, comprising (1) (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof, (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and (3) a hydrogel-forming polymer having an average molecular weight of approximately 100,000 or more, or a viscosity of 12 mPa·s or more at a 5% aqueous solution at 25° C. is disclosed.
Patent expiration dates:
- September 28, 2029✓✓
- September 28, 2029✓✓
- September 28, 2029
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Pharmaceutical composition for modified release
Patent 10842780*PE
Issued: November 24, 2020
Inventor(s): Takaishi Yuuki & Takahashi Yutaka & Nishizato Takashi & Murayama Daisuke & Murayama Emiko & Nakamura Soichiro & Sako Kazuhiro
Assignee(s): ASTELLAS PHARMA INC.A pharmaceutical composition for modified release, comprising (1) (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof, (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and (3) a hydrogel-forming polymer having an average molecular weight of approximately 100,000 or more, or a viscosity of 12 mPa·s or more at a 5% aqueous solution at 25° C. is disclosed.
Patent expiration dates:
- March 28, 2030
- March 28, 2030
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Patent 11,707,451
Patent expiration dates:
- September 28, 2029✓
- September 28, 2029✓
- September 28, 2029
-
Patent 11707451*PE
Patent expiration dates:
- March 28, 2030
- March 28, 2030
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Patent 12,059,409
Patent expiration dates:
- September 28, 2029✓
- September 28, 2029
-
Patent 12,097,189
Patent expiration dates:
- September 28, 2029✓
- September 28, 2029✓
- September 28, 2029
-
Patent 7342117*PED
Patent expiration dates:
- May 4, 2024✓
- May 4, 2024
-
Patent 7982049*PED
Patent expiration dates:
- May 4, 2024✓
- May 4, 2024
-
Pharmaceutical composition for treating overactive bladder
Patent 8,772,315
Issued: July 8, 2014
Inventor(s): Suzuki Masanori & Ukai Masashi & Ohtake Akiyoshi
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✓
- October 30, 2028
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Pharmaceutical composition for treating overactive bladder
Patent 8772315*PED
Issued: July 8, 2014
Inventor(s): Suzuki Masanori & Ukai Masashi & Ohtake Akiyoshi
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:
- April 30, 2029✓
- April 30, 2029
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Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Patent 8835474*PED
Issued: September 16, 2014
Inventor(s): Takasu Toshiyuki & Sato Shuichi & Ukai Masashi & Maruyama Tatsuya & Shibasaki Masayuki
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:
- May 4, 2024✓
- May 4, 2024
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Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Patent RE44872*PED
Issued: April 29, 2014
Inventor(s): Takasu Toshiyuki & Sato Shuichi & Ukai Masashi & Maruyama Tatsuya & Shibasaki Masayuki
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:
- May 4, 2024✓
- May 4, 2024
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 - TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE
- March 25, 2024 - NEW PRODUCT
- September 25, 2024 - PEDIATRIC EXCLUSIVITY
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Glossary
Term | Definition |
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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
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