Monday, October 24, 2016

Amitiza


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


AMITIZA (lubiprostone - capsule; oral)



  • Manufacturer: SUCAMPO PHARMS

    Approval date: January 31, 2006

    Strength(s): 24MCG [RLD]


  • Manufacturer: SUCAMPO PHARMS

    Approval date: April 29, 2008

    Strength(s): 8MCG

Has a generic version of Amitiza been approved?


No. There is currently no therapeutically equivalent version of Amitiza available.


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




  • Prostaglandins E and anti ulcers containing same
    Patent 5,284,858
    Issued: February 8, 1994
    Inventor(s): Ueno; Ryuzo & Ueno; Ryuji & Kato; Ichie & Oda; Tomio
    Assignee(s): Kabushiki Kaisha Ueno Seiyaku Oyo Kenkyujo
    The novel 13, 14-dihydro-15-keto prostaglandins E of the invention have remarkable preventive effects against ulcers. Further, the novel 13,14-dihydro-15-ketoprostaglandins E of the invention have an advatage that they have none of side effects which prostaglandin E intrinsically has, or can remarakably reduce such effects of the prostaglandin E. Therefore, the novel 13, 14-dihydro-15-keto prostaglandins E of the invention are effective for animal and human use for treatment and prevention of ulcers, such as duodenal ulcer and gastric ulcer.
    Patent expiration dates:

    • July 14, 2014
      ✓ 
      Drug substance




  • Anti-constipation composition
    Patent 6,414,016
    Issued: July 2, 2002
    Inventor(s): Ryuji; Ueno
    Assignee(s): Sucampo, A.G.
    An object of the present invention is to provide an anti-constipation composition containing a halogenated-bi-cyclic compound as an active ingredient in a ratio of bi-cyclic/mono-cyclic structure of at least 1:1. The halogenated-bi-cyclic compound is represented by Formula (I): where X1 and X2 are preferably both fluorine atoms. The composition can be used to treat constipation without substantive side-effects, such as stomachache.
    Patent expiration dates:

    • September 5, 2020
      ✓ 
      Patent use: METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT


    • September 5, 2020
      ✓ 
      Patent use: METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME




  • Composition and method for stabilizing the same
    Patent 6,583,174
    Issued: June 24, 2003
    Inventor(s): Ryuji; Ueno & Tsuyoshi; Habe
    Assignee(s): Sucampo, A.G.
    Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.
    Patent expiration dates:

    • October 16, 2020
      ✓ 
      Drug product




  • Chloride channel opener
    Patent 7,064,148
    Issued: June 20, 2006
    Inventor(s): Ueno; Ryuji & Cuppoletti; John
    Assignee(s): Sucampo AG
    Disclosed is a novel use of a prostaglandin compound as a chloride channel opener. According to the instant invention, chloride channels in a mammalian subject can be opened by a prostaglandin compound to facilitate chloride ion transportation.
    Patent expiration dates:

    • August 30, 2022
      ✓ 
      Patent use: METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT


    • August 30, 2022
      ✓ 
      Patent use: METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY OPENING CHLORIDE CHANNELS (CIC)




  • Composition and method for stabilizing the same
    Patent 7,417,067
    Issued: August 26, 2008
    Inventor(s): Ueno; Ryuji & Habe; Tsuyoshi
    Assignee(s): Sucampo AG
    Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.
    Patent expiration dates:

    • October 16, 2020
      ✓ 
      Drug product




  • Method for treating abdominal discomfort
    Patent 7,795,312
    Issued: September 14, 2010
    Inventor(s): Ueno; Ryuji & Kuno; Sachiko
    Assignee(s): Sucampo AG
    A method for treating irritable bowel syndrome in a mammalian subject includes administering an effective amount of 13,14-dihydro-15-keto-16,16-difluoro-18-methyl-prostaglandin E1 or 13,14-dihydro-15-keto-16,16-difluoro-prostaglandin E1, or a salt, ether, ester or amide thereof, to the subject. A method for treating abdominal discomfort associated with irritable bowel syndrome in a mammalian subject includes administering an effective amount of 13,14-dihydro-15-keto-16,16-difluoro-18-methyl-prostaglandin E1 or 13,14-dihydro-15-keto-16,16-difluoro-prostaglandin E1, or a salt, ether, ester or amide thereof, to the subject.
    Patent expiration dates:

    • September 17, 2024
      ✓ 
      Patent use: METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME




  • Soft-gelatin capsule formulation
    Patent 8,026,393
    Issued: September 27, 2011
    Inventor(s): Hashitera; Yukiko & Hirata; Ryu & Harada; Yasuhiro & Ueno; Ryuji
    Assignee(s): Sucampo AG
    R-Tech Ueno, Ltd.
    The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.
    Patent expiration dates:

    • October 25, 2027
      ✓ 
      Drug product




  • Anti-constipation composition
    Patent 8,071,613
    Issued: December 6, 2011
    Inventor(s): Ueno; Ryuji
    Assignee(s): Sucampo AG
    An object of the present invention is to provide an anti-constipation composition containing a halogenated-bi-cyclic compound as an active ingredient in a ratio of bi-cyclic/mono-cyclic structure of at least 1:1. The halogenated-bi-cyclic compound is represented by Formula (I): where X1 and X2 are preferably both fluorine atoms. The composition can be used to treat constipation without substantive side-effects, such as stomachache.
    Patent expiration dates:

    • September 5, 2020
      ✓ 
      Patent use: METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT


    • September 5, 2020
      ✓ 
      Patent use: METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME




  • Composition and method for stabilizing the same
    Patent 8,088,934
    Issued: January 3, 2012
    Inventor(s): Ueno; Ryuji & Habe; Tsuyoshi
    Assignee(s): SUCAMPO AG
    Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.
    Patent expiration dates:

    • May 18, 2021
      ✓ 
      Drug substance




  • Composition and method for stabilizing the same
    Patent 8,097,649
    Issued: January 17, 2012
    Inventor(s): Ueno; Ryuji & Habe; Tsuyoshi
    Assignee(s): Sucampo AG
    Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.
    Patent expiration dates:

    • October 16, 2020
      ✓ 
      Drug product




  • Dosage unit comprising a prostaglandin analog for treating constipation
    Patent 8,097,653
    Issued: January 17, 2012
    Inventor(s): Ueno; Ryuji & Patchen; Myra L.
    Assignee(s): Sucampo AG
    A dosage unit for treating constipation in a human patient is described. The dosage unit of the invention comprises a halogenated prostaglandin analog and a pharmaceutically suitable excipient. The dosage unit relieves constipation without substantial side effects.
    Patent expiration dates:

    • November 14, 2022
      ✓ 
      Patent use: METHOF FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT




  • Anti-constipation composition
    Patent 8,114,890
    Issued: February 14, 2012
    Inventor(s): Ueno; Ryuji
    Assignee(s): Sucampo AG
    An object of the present invention is to provide an anti-constipation composition containing a halogenated-bi-cyclic compound as an active ingredient in ratio of bi-cyclic/mono-cyclic structure of at least 1:1. The halogenated-bi-cyclic compound is represented by Formula (I): where X1 and X2 are preferably both fluorine atoms. The composition can be used to treat constipation with out substantive side-effects, such as stomachache.
    Patent expiration dates:

    • September 5, 2020
      ✓ 
      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:
    • January 31, 2011 - NEW CHEMICAL ENTITY

    • April 28, 2011 - NEW STRENGTH

    • April 28, 2011 - USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD

See also...

  • Amitiza Consumer Information (Drugs.com)
  • Amitiza Consumer Information (Wolters Kluwer)
  • Amitiza Consumer Information (Cerner Multum)
  • Amitiza Advanced Consumer Information (Micromedex)
  • Amitiza AHFS DI Monographs (ASHP)
  • Lubiprostone Consumer Information (Wolters Kluwer)
  • Lubiprostone Consumer Information (Cerner Multum)
  • Lubiprostone Advanced Consumer Information (Micromedex)
  • Lubiprostone AHFS DI Monographs (ASHP)

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