Wednesday, September 28, 2016

Dexilant


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.


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
      ✓ 
      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
      ✓ 
      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: MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • 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: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • December 15, 2020
      ✓ 
      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


    • June 15, 2020
      ✓ 
      Patent use: HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 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
      ✓ 
      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
      ✓ 
      Drug product


    • February 2, 2027
      ✓ 
      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:
    • January 30, 2012 - NEW PRODUCT

    • July 30, 2012 - PEDIATRIC EXCLUSIVITY

See also...

  • Dexilant Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Dexilant Consumer Information (Cerner Multum)
  • Dexilant Advanced Consumer Information (Micromedex)
  • Dexlansoprazole Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Dexlansoprazole Consumer Information (Cerner Multum)
  • Dexlansoprazole Advanced Consumer Information (Micromedex)
  • Dexlansoprazole AHFS DI Monographs (ASHP)

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