Generic Dexilant Availability

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

DEXILANT (dexlansoprazole - capsule, delayed release;oral)

  • Manufacturer: TAKEDA PHARMS
    Approval date: January 30, 2009
    Strength(s): 30MG, 60MG [RLD]

Has a generic version of Dexilant been approved?

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

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

  • 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
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      Drug product
    • June 15, 2020
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      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
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      Drug substance
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      Drug product
    • June 15, 2020
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      Patent use: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
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      Drug substance
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      Drug product
    • December 15, 2020
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      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:
    • June 15, 2020
      ✓ 
      Patent use: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 15, 2020
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 15, 2020
      ✓ 
      Patent use: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 15, 2020
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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: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
    • June 15, 2020
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
    • June 15, 2020
      ✓ 
      Patent use: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
    • December 15, 2020
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      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
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      Drug substance
    • December 15, 2020
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      Pediatric exclusivity
  • Controlled release preparation
    Patent 7,790,755
    Issued: September 7, 2010
    Inventor(s): Akiyama; Yohko & Kurasawa; Takashi & Bando; Hiroto & Nagahara; Naoki
    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:
    • August 2, 2026
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      Drug product
    • February 2, 2027
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      Pediatric exclusivity
  • Granules containing acid-unstable chemical in large amount
    Patent 8,105,626
    Issued: January 31, 2012
    Inventor(s): Shimizu; Toshihiro & Nakano; Yoshinori
    Assignee(s): Takeda Pharmaceutical Company Limited
    It is intended to provide preparations such as capsules containing an acid-unstable medicament (in particular, a benzimidazole compound having an antiulcer effect, etc.) at a high concentration which are prepared by using about 12% by weight or more (based on the total granules) of the acid-unstable chemical and blending a basic inorganic salt therewith to give granules of about 600 μm or more in the average particle size.
    Patent expiration dates:
    • September 27, 2026
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      Drug product
    • March 27, 2027
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      Pediatric exclusivity
  • Methods of treating gastrointestinal disorders independent of the intake of food
    Patent 8,173,158
    Issued: May 8, 2012
    Inventor(s): Lee; Ronald D. & Vakily; Majid & Mulford; Darcy & Wu; Jing-Tao & Atkinson; Stuart
    Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.
    The present invention relates to a method of treating a gastrointestinal disorder by administering to a patient in need of treatment thereof a pharmaceutical composition, wherein said pharmaceutical composition can be administered to the patient independent of the intake of food.
    Patent expiration dates:
    • March 17, 2030
      ✓ 
      Patent use: TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
    • March 17, 2030
      ✓ 
      Patent use: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
    • March 17, 2030
      ✓ 
      Patent use: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
    • September 17, 2030
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      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

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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