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Generic Prestalia Availability

Prestalia is a brand name of amlodipine/perindopril, approved by the FDA in the following formulation(s):

PRESTALIA (amlodipine besylate; perindopril arginine - tablet;oral)

  • Manufacturer: SYMPLMED PHARMS LLC
    Approval date: January 21, 2015
    Strength(s): EQ 2.5MG BASE;3.5MG, EQ 5MG BASE;7MG, EQ 10MG BASE;14MG [RLD]

Has a generic version of Prestalia been approved?

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

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

  • Salt of perindopril and pharmaceutical compositions containing it
    Patent 6,696,481
    Issued: February 24, 2004
    Inventor(s): Gérard; Damien & François; Lefoulon & Bernard; {acute over (M)}archand
    Assignee(s): Les Laboratoires Servier
    The present invention relates to a new salt of perindopril and to pharmaceutical compositions containing it, and Medicaments for treatment of hypertension and heart failure.
    Patent expiration dates:
    • April 15, 2023
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      Patent use: TREATMENT OF HYPERTENSION
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      Drug substance
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      Drug product
  • α crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
    Patent 7,846,961
    Issued: December 7, 2010
    Inventor(s): Coquerel; Gérard & Lefebvre; Loïc & Souvie; Jean-Claude & Authouart; Pascale
    Assignee(s): Les Laboratoires Servier
    α-crystalline form of the compound of formula (I): characterized by its powder X-ray diffraction diagram. Medicinal products containing the same which are useful as inhibitors of angiotensin I converting enzyme.
    Patent expiration dates:
    • October 5, 2029
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      Patent use: TREATMENT OF HYPERTENSION
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      Drug substance
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      Drug product

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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