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Generic Amitiza Availability

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

AMITIZA (lubiprostone - capsule;oral)

  • Manufacturer: SUCAMPO PHARMA LLC
    Approval date: January 31, 2006
    Strength(s): 24MCG [RLD]
  • Manufacturer: SUCAMPO PHARMA LLC
    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 in the United States.

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.

  • 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
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      Patent use: METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-INDUCED CONSTIPATION
    • September 5, 2020
      ✓ 
      Patent use: METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
    • September 5, 2020
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      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
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      Drug product
  • Method for treating drug-induced constipation
    Patent 6,982,283
    Issued: January 3, 2006
    Inventor(s): Ueno; Ryuji
    Assignee(s): Sucampo AG
    Provided is a method for treating drug-induced constipation comprising a step of administering an effective amount of a 15-keto-prostaglaindin compound to a subject suffering from drug-induced constipation or a subject having a strong possibility of suffering from it. According to the present invention, a strong antagonistic action against drug-induced constipation can be obtained without substantially losing the main effect of the drug.
    Patent expiration dates:
    • December 4, 2022
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      Patent use: METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
  • 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
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      Patent use: METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS
    • August 30, 2022
      ✓ 
      Patent use: METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
    • August 30, 2022
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      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
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      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
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      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
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      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 PATIENT WITH OPIOID-INDUCED CONSTIPATION
    • September 5, 2020
      ✓ 
      Patent use: METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
    • September 5, 2020
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      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
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      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
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      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
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      Patent use: METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/- 10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
    • November 14, 2022
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      Patent use: METHOD 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
  • Soft-gelatin capsule formulation
    Patent 8,338,639
    Issued: December 25, 2012
    Inventor(s): Hashitera; Yukiko & Hirata; Ryu & Harada; Yasuhiro & Ueno; Ryuji
    Assignee(s): Sucampo AG R-Tech Ueno, Ltd.
    The present invention provides a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which includes: a soft gelatin capsule shell including gelatin and sugar alcohol as a plasticizer, and a mixture including 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:
    • January 23, 2027
      ✓ 
      Drug product
  • Dosage unit comprising a prostaglandin analog for treating constipation
    Patent 8,389,542
    Issued: March 5, 2013
    Assignee(s): Sucampo AG
    A dosage unit for treating constipation in a human patient is described. The dosage unit of the invention includes a halogenated prostaglandin analog and a pharmaceutically suitable excipient. The dosage unit relieves constipation without substantial side effects. In particular, the dosage unit includes a prostaglandin (PG) analog represented by Formula (I) and/or its tautomers, and a pharmaceutically suitable excipient, wherein the dosage unit contains the PG analog in an amount of 24 μg+/−10%:
    Patent expiration dates:
    • November 14, 2022
      ✓ 
      Patent use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
      ✓ 
      Drug product
    • November 14, 2022
      ✓ 
      Patent use: USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
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      Drug product
  • Method for treating gastrointestinal disorder
    Patent 8,748,481
    Issued: June 10, 2014
    Assignee(s): Sucampo AG
    The present invention relates to a method for the long term treatment of gastrointestinal disorders in a human subject, which comprises administering an effective amount of a halogenated prostaglandin compound and/or its tautomer to the subject. The method induces substantially no electrolyte shifting during the term of the treatment. The compound used in the present invention can improve quality of life in the human subjects with gastrointestinal disorders, are similarly effective in treating male and female subjects, and also effective in a human subject aged even 65 years and older.
    Patent expiration dates:
    • September 1, 2025
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      Patent use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH IRRITABLE BOWEL SYNDROME
    • September 1, 2025
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      Patent use: METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT
  • Soft-gelatin capsule formulation
    Patent 8,779,187
    Issued: July 15, 2014
    Assignee(s): Sumcampo 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:
    • July 23, 2027
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      Drug product
    • January 23, 2027
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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:
    • April 19, 2016 - TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC, NON-CANCER PAIN

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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