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Generic ella Availability

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

ELLA (ulipristal acetate - tablet;oral)

  • Manufacturer: LAB HRA PHARMA
    Approval date: August 13, 2010
    Strength(s): 30MG [RLD]

Has a generic version of ella been approved?

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

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

  • Method for providing emergency contraception
    Patent 8,426,392
    Issued: April 23, 2013
    Assignee(s): Laboratoire HRA-Pharma
    The invention provides a method for providing emergency contraception in a female subject, comprising providing the subject with a therapeutically effective amount of ulipristal acetate in an oral dosage form before, during or after a meal. The invention further provides a kit comprising i) an oral dosage form comprising ulipristal acetate and ii) a printed matter stating that ulipristal acetate may be taken with or without food.
    Patent expiration dates:
    • June 12, 2030
      ✓ 
      Patent use: ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
  • Ulipristal acetate tablets
    Patent 8,512,745
    Issued: August 20, 2013
    Assignee(s): Laboratoire HRA Pharma
    The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: a diluent in an amount of 60 to 95 wt %, a binding agent in an amount of 1 to 10 wt %, croscarmellose sodium in an amount of 1 to 10 wt %, and magnesium stearate in an amount of 0 to 5 wt %.
    Patent expiration dates:
    • June 2, 2030
      ✓ 
      Drug product
  • Ulipristal acetate tablets
    Patent 8,735,380
    Issued: May 27, 2014
    Assignee(s): Laboratoire HRA Pharma
    The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: at least one diluent in an amount of 50 to 98.5 wt %, at least one binding agent in an amount of 0 to 10 wt %, at least one disintegrating agent in an amount of 0.5 to 10 wt %, and at least one lubricant in an amount of 0 to 10 wt %.
    Patent expiration dates:
    • February 20, 2029
      ✓ 
      Drug product
  • Method for post coital contraception in overweight or obese female subjects using ulipristal acetate
    Patent 8,962,603
    Issued: February 24, 2015
    Assignee(s): Laboratoire HRA-Pharma
    The invention provides a method for providing post coital contraception in a female subject, comprising providing the subject with a therapeutically effective amount of ulipristal acetate, wherein the female subject is overweight or obese.
    Patent expiration dates:
    • June 12, 2030
      ✓ 
      Patent use: METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT 30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE, WHEREIN THE WOMAN IS OVERWEIGHT HAVING A BMI OF 25 TO 29.99
  • Method for on-demand contraception
    Patent 9,283,233
    Issued: March 15, 2016
    Assignee(s): LABORATOIRE HRA-PHARMA The United States of America, as represented by the Secretary, Department of Health and Human Services
    The invention relates to a method for on-demand contraception, which method comprises administering a progestogen agent or progesterone receptor modulator, such as 17a-acetoxy-11b-(4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) in a woman, within 72 hours before an intercourse or within 120 hours after the intercourse.
    Patent expiration dates:
    • April 13, 2030
      ✓ 
      Patent use: METHOD FOR CONTRACEPTION TO A WOMAN COMPRISING ADMINISTERING TO THE WOMAN 30MG OF ULIPRISTAL ACETATE MORE THAN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE

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:
    • August 13, 2015 - NEW CHEMICAL ENTITY

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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