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Generic Dexilant SoluTab Availability

See also: Generic Dexilant

Dexilant SoluTab is a brand name of dexlansoprazole, approved by the FDA in the following formulation(s):

DEXILANT SOLUTAB (dexlansoprazole - tablet, orally disintegrating, delayed release;oral)

  • Manufacturer: TAKEDA PHARMS USA
    Approval date: January 26, 2016
    Strength(s): 30MG [RLD]

Has a generic version of Dexilant SoluTab been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dexilant SoluTab. 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.

  • Orally disintegrable tablets
    Patent 6,328,994
    Issued: December 11, 2001
    Inventor(s): Shimizu; Toshihiro & Morimoto; Shuji & Tabata; Tetsuro
    Assignee(s): Takeda Chemical Industries, Ltd.
    An orally disintegrable tablet, of the present invention, which comprises (i) fine granules having an average particle diameter of 400 .mu.m or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
    Patent expiration dates:
    • May 17, 2019
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      Drug product
    • November 17, 2019
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      Pediatric exclusivity
  • Benzimidazole compound crystal
    Patent 6,462,058
    Issued: October 8, 2002
    Inventor(s): Akira; Fujishima & Isao; Aoki & Keiji; Kamiyama
    Assignee(s): Takeda Chemical Industries, Ltd.
    A novel crystal of (R)-2-[[[3-methyl-4-(2, 2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole or a salt thereof of the present invention is useful for an excellent antiulcer agent.
    Patent expiration dates:
    • June 15, 2020
      ✓ 
      Patent use: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
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      Drug substance
      ✓ 
      Drug product
    • June 15, 2020
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 15, 2020
      ✓ 
      Pediatric exclusivity
  • Benzimidazole compound crystal
    Patent 6,664,276
    Issued: December 16, 2003
    Inventor(s): Akira; Fujishima & Isao; Aoki & Keiji; Kamiyama
    Assignee(s): Takeda Chemical Industries, Ltd.
    A novel crystal of (R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole or a salt thereof of the present invention is useful for an excellent antiulcer agent.
    Patent expiration dates:
    • January 30, 2023
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 30, 2023
      ✓ 
      Patent use: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 30, 2023
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      Pediatric exclusivity
  • Benzimidazole compound crystal
    Patent 6,939,971
    Issued: September 6, 2005
    Inventor(s): Fujishima; Akira & Aoki; Isao & Kamiyama; Keiji
    Assignee(s): Takeda Pharmaceutical Company, Ltd.
    A novel crystal of (R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole or a salt thereof of the present invention is useful for an excellent antiulcer agent.
    Patent expiration dates:
    • June 15, 2020
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
    • June 15, 2020
      ✓ 
      Patent use: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
    • December 15, 2020
      ✓ 
      Pediatric exclusivity
  • Process for the crystallization of (R)- or (S)-lansoprazole
    Patent 7,285,668
    Issued: October 23, 2007
    Inventor(s): Hashimoto; Hideo & Urai; Tadashi
    Assignee(s): Takeda Pharmaceutical Company Limited
    The present invention relates to a production method of a crystal of (R)-lansoprazole or (S)-lansoprazole, which includes crystallization at a temperature of about 0° C. to about 35° C. from a C1-4 alkyl acetate solution containing (R)-lansoprazole or (S)-lansoprazole at a concentration of about 0.1 g/mL to about 0.5 g/mL and the like. According to the production method of the present invention, a crystal of (R)-lansoprazole or (S)-lansoprazole superior in preservation stability can be produced efficiently on an industrial large scale.
    Patent expiration dates:
    • June 15, 2020
      ✓ 
      Drug substance
    • December 15, 2020
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      Pediatric exclusivity
  • Rapidly Disintegrable solid preparation
    Patent 7,399,485
    Issued: July 15, 2008
    Inventor(s): Shimizu; Toshihiro & Sugaya; Masae & Nakano; Yoshinori
    Assignee(s): Takeda Pharmaceutical Company Limited
    A rapidly disintegrable solid preparation which comprises (i) a pharmacologically active ingredient, (ii) a sugar and (iii) a low-substituted hydroxypropylcellulose having 5% by weight or more to less than 7% by weight of hydroxypropoxyl group. The rapidly disintegrable solid preparation has fast disintegrability, suitable strength and no roughness.
    Patent expiration dates:
    • May 26, 2018
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      Drug product
    • November 26, 2018
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      Pediatric exclusivity
  • Orally disintegrable tablets
    Patent 7,431,942
    Issued: October 7, 2008
    Inventor(s): Shimizu; Toshihiro & Morimoto; Shuji & Tabata; Tetsuro
    Assignee(s): Takeda Pharmaceutical Company Limited
    An orally disintegrable tablet of the present invention, which comprises (i) fine granules having an average particle diameter of 400 μm or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
    Patent expiration dates:
    • May 17, 2019
      ✓ 
      Drug product
    • November 17, 2019
      ✓ 
      Pediatric exclusivity
  • Orally disintegrable tablets
    Patent 7,875,292
    Issued: January 25, 2011
    Inventor(s): Shimizu; Toshihiro & Morimoto; Shuji & Tabata; Tetsuro
    Assignee(s): Takeda Pharmaceutical Company Limited
    An orally disintegrable tablet, of the present invention, which comprises (i) fine granules having an average particle diameter of 400 μm or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
    Patent expiration dates:
    • May 17, 2019
      ✓ 
      Drug product
    • November 17, 2019
      ✓ 
      Pediatric exclusivity
  • Multiple PPI dosage form
    Patent 8,461,187
    Issued: June 11, 2013
    Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.
    Herein provided are dosage forms (variously referred to as “formulations”) comprising a PPI that is released from the dosage form as a first and a second dose. Each dose of PPI is present in an amount sufficient to raise the plasma levels of the PPI to at least 100 ng/ml.
    Patent expiration dates:
    • January 17, 2026
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      Drug product
    • July 17, 2026
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      Pediatric exclusivity
  • Controlled release preparation
    Patent 8,784,885
    Issued: July 22, 2014
    Assignee(s): Takeda Pharmaceutical Company Limited
    A controlled release preparation wherein the release of active ingredient is controlled, which releases an active ingredient for an extended period of time by staying or slowly migrating in the gastrointestinal tract, is provided by means such as capsulating a tablet, granule or fine granule wherein the release of active ingredient is controlled and a gel-forming polymer. Said tablet, granule or fine granule has a release-controlled coating-layer formed on a core particle containing an active ingredient.
    Patent expiration dates:
    • October 15, 2023
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      Drug product
    • April 15, 2024
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      Pediatric exclusivity
  • Method for producing granules
    Patent 8,871,273
    Issued: October 28, 2014
    Assignee(s): Takeda Pharmaceutical Company Limited
    In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50° C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
    Patent expiration dates:
    • January 11, 2028
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      Drug product
    • July 11, 2028
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      Pediatric exclusivity
  • Method for producing granules
    Patent 9,011,926
    Issued: April 21, 2015
    Assignee(s): Takeda Pharmaceutical Company Limited
    In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50° C. or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
    Patent expiration dates:
    • February 24, 2026
      ✓ 
      Drug product
  • Benzimidazole compound crystal
    Patent 9,145,389
    Issued: September 29, 2015
    Assignee(s): Takeda Pharmaceutical Company Limited
    A novel crystal of (R)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole or a salt thereof of the present invention is useful for an excellent antiulcer agent.
    Patent expiration dates:
    • June 15, 2020
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Multiple PPI dosage form
    Patent 9,238,029
    Issued: January 19, 2016
    Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.
    Herein provided are dosage forms (variously referred to as “formulations”) comprising a PPI that is released from the dosage form as a first and a second dose. Each dose of PPI is present in an amount sufficient to raise the plasma levels of the PPI to at least 100 ng/ml.
    Patent expiration dates:
    • January 17, 2026
      ✓ 
      Drug product
  • Orally-disintegrating solid preparation
    Patent 9,241,910
    Issued: January 26, 2016
    Assignee(s): Takeda Pharmaceutical Company Limited
    The present invention provides an orally-disintegrating solid preparation such as a tablet produced by tabletting fine granules showing controlled release of a pharmaceutically active ingredient and an additive, and the like, and the orally-disintegrating solid preparation containing fine granules coated with a coating layer containing a polymer affording a casting film having an elongation at break of about 100-about 700%. With the preparation, breakage of fine granules during tabletting can be suppressed in the production of an orally-disintegrating solid preparation containing fine granules showing controlled release of a pharmaceutically active ingredient.
    Patent expiration dates:
    • March 10, 2029
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      Drug product

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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