Generic Steglujan Availability
Last updated on Nov 6, 2024.
Steglujan is a brand name of ertugliflozin/sitagliptin, approved by the FDA in the following formulation(s):
STEGLUJAN (ertugliflozin; sitagliptin phosphate - tablet;oral)
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Manufacturer: MSD SUB MERCK
Approval date: December 19, 2017
Strength(s): 5MG;EQ 100MG BASE [RLD], 15MG;EQ 100MG BASE [RLD]
Has a generic version of Steglujan been approved?
No. There is currently no therapeutically equivalent version of Steglujan available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Steglujan. 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: Generic Drug FAQ.
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.
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Patent 7,326,708
Patent expiration dates:
- November 24, 2026✓✓✓
- November 24, 2026
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Patent 7326708*PED
Patent expiration dates:
- May 24, 2027✓
- May 24, 2027
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Patent 8,080,580
Patent expiration dates:
- July 13, 2030✓✓✓
- July 13, 2030
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Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent 9,308,204
Issued: April 12, 2016
Inventor(s): Mascitti Vincent
Assignee(s): Pfizer Inc.Compounds of Formula (A) and (B) are described herein and the uses thereof for the treatment of diseases, conditions and/or disorders mediated by sodium-glucose transporter inhibitors (in particular, SGLT2 inhibitors).
Patent expiration dates:
- October 21, 2030✓
- October 21, 2030
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Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent 9,439,901
Issued: September 13, 2016
Inventor(s): Mascitti Vincent
Assignee(s): Pfizer Inc.Compounds of Formula (A) and (B) are described herein and the uses thereof for the treatment of diseases, conditions and/or disorders mediated by sodium-glucose transporter inhibitors (in particular, SGLT2 inhibitors).
Patent expiration dates:
- October 21, 2030✓
- October 21, 2030
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:
- September 17, 2024 - REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
More about Steglujan (ertugliflozin / sitagliptin)
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- Drug class: antidiabetic combinations
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Glossary
Term | Definition |
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Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.