Generic Myrbetriq Availability

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, 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: 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.

  • 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:
    • October 15, 2018
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      Drug substance
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      Drug product
  • Stable pharmaceutical composition for oral use
    Patent 6,562,375
    Issued: May 13, 2003
    Inventor(s): Kazuhiro; Sako & Toyohiro; Sawada & Keiichi; Yoshihara & Tatsunobu; Yoshioka & Shunsuke; Watanabe
    Assignee(s): Yamanouchi Pharmaceuticals, Co., Ltd.
    The present invention is to provide a stable pharmaceutical composition for oral use and preparation thereof in which changes are prevented in drug release at stored even under the exposure to light by adding yellow ferric oxide and/or red ferric oxide in a matrix type sustained-release preparation containing a drug, hydrophilic base, and polyethylene oxide. The present invention is to further provide a method for preventing changes in drug release at stored under the exposure to light in a matrix type sustained-release preparation containing a drug, hydrophilic base, and polyethylene oxide. The quality assurance period of the product can be prolonged and the product value can be improved by the present invention.
    Patent expiration dates:
    • August 1, 2020
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  • Hydrogel-forming sustained-release preparation
    Patent 6,699,503
    Issued: March 2, 2004
    Inventor(s): Kazuhiro; Sako & Hiroshi; Nakashima & Toyohiro; Sawada & Akira; Okada & Muneo; Fukui
    Assignee(s): Yamanuchi Pharmaceutical Co., Ltd.
    The invention provides a hydrogen-type sustained-release preparation comprising (1) at least one drug, (2) an additive which insures a penetration of water into the core of the preparation and (3) a hydrogen-forming polymer, wherein said preparation is capable of undergoing substantially complete gelation during its stay in the upper digestive tract such as stomach and small intestine and is capable of releasing the drug in the lower digestive tract including colon. By the preparation of the invention, the drug is efficiently released and absorbed even in the colon so that a steady and sustained release effect can be achieved.
    Patent expiration dates:
    • September 10, 2013
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  • 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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  • Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
    Patent 7,750,029
    Issued: July 6, 2010
    Inventor(s): Takasu; Toshiyuki & Sato; Shuichi & Ukai; Masashi & Maruyama; Tatsuya
    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:
    • December 18, 2023
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      Patent use: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY
  • 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

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:
    • June 28, 2017 - NEW CHEMICAL ENTITY

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.
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