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Generic Twirla Availability

Last updated on Oct 6, 2021.

Twirla is a brand name of ethinyl estradiol/levonorgestrel, approved by the FDA in the following formulation(s):

TWIRLA (ethinyl estradiol; levonorgestrel - system;transdermal)

  • Manufacturer: AGILE
    Approval date: February 14, 2020
    Strength(s): 0.03MG/24HR;0.12MG/24HR [RLD]

Has a generic version of Twirla been approved?

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

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

  • Transdermal contraceptive delivery system and process
    Patent 7,045,145
    Issued: May 16, 2006
    Inventor(s): Chien; Te-Yen
    Assignee(s): Agile Therapeutics, Inc.

    A transdermal contraceptive delivery system (TCDS) for fertility control in women is described. It comprises a backing layer, an adjoining layer of a solid absorption adhesive polymer matrix in which effective daily doses of an estrogen and a progestin are dispersed and released for transdermal absorption. Presently preferred is the use of the synthetic estrogen, ethinyl estradiol, and the synthetic progestin, levonorgestrel. Along with these two steroidal contraceptive agents, a combination of several chemical skin permeation enhancing agents, including capric acid, blended at specific weight ratios, ranging from 2:1:1:0.8 to 6:1:1:0.8, are homogeneously dispersed in the adhesive polymer matrix. The invention also provides a method of fertility control utilizing the transdermal contraceptive delivery system.

    Patent expiration dates:

    • March 14, 2021
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      Patent use: A TRANSDERMAL METHOD OF CONTRACEPTION
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      Drug product
  • Skin permeation enhancement composition for transdermal hormone delivery system
    Patent 7,384,650
    Issued: June 10, 2008
    Inventor(s): Chien; Te-Yen
    Assignee(s): Agile Therapeutics, Inc.

    A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

    Patent expiration dates:

    • March 14, 2021
      ✓ 
      Drug product
  • Transdermal hormone delivery system: compositions and methods
    Patent 8,221,784
    Issued: July 17, 2012
    Inventor(s): Chien; Te-Yen
    Assignee(s): Agile Therapeutics, Inc.

    A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

    Patent expiration dates:

    • March 14, 2021
      ✓ 
      Drug product
  • Transdermal hormone delivery system: compositions and methods
    Patent 8,221,785
    Issued: July 17, 2012
    Inventor(s): Chien; Te-Yen
    Assignee(s): Agile Therapeutics, Inc.

    A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

    Patent expiration dates:

    • March 14, 2021
      ✓ 
      Drug product
  • Dermal delivery device with reduced loss of its volatile components
    Patent 8,246,978
    Issued: August 21, 2012
    Inventor(s): Kydonieus; Agis & Conway; Robert G. & Rossi; Thomas M.
    Assignee(s): Agile Therapeutics, Inc.

    This invention relates to a transdermal drug delivery device that comprises an active ingredient (AI) layer, having a skin contacting surface and a non-skin contacting surface and comprising a volatile component, a release liner impermeable to the volatile component adjacent the skin contacting surface of the AI layer having a perimeter that extends beyond the perimeter of the AI layer in all directions, and an overlay comprising a pressure sensitive adhesive (PSA) that does not absorb the volatile component adjacent the non-skin contacting surface of the AI layer having a perimeter of which extends beyond the perimeter of the AI layer in all directions, wherein the release liner and the PSA of the overlay are in contact with and adhered to each other around the perimeter of the AI layer to form a seal that reduces or prevents volatile component loss.

    Patent expiration dates:

    • August 26, 2028
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      Drug product
  • Dermal delivery device with in situ seal
    Patent 8,747,888
    Issued: June 10, 2014
    Assignee(s): Agile Therapeutics, Inc.

    This invention relates to a transdermal drug delivery device that comprises an active ingredient (AI) layer, having a skin contacting surface and a non-skin contacting surface and comprising a volatile component, a release liner impermeable to the volatile component adjacent the skin contacting surface of the AI layer having a perimeter that extends beyond the perimeter of the AI layer in all directions, and an overlay comprising a pressure sensitive adhesive (PSA) that does not absorb the volatile component adjacent the non-skin contacting surface of the Al layer having a perimeter of which extends beyond the perimeter of the AI layer in all directions, wherein the release liner and the PSA of the overlay are in contact with and adhered to each other around the perimeter of the AI layer to form a seal that reduces or prevents volatile component loss.

    Patent expiration dates:

    • July 10, 2028
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      Drug product
  • Dermal delivery device
    Patent 9,050,348
    Issued: June 9, 2015
    Assignee(s): Agile Therapeutics, Inc.

    A transdermal drug delivery device is disclosed. Over an extended wear period, the device causes cumulative moderate irritation plus significant irritation of less than 5% and/or achieves a meaningful degree of detachment over a seven day period of less than 20%.

    Patent expiration dates:

    • July 10, 2028
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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:

    • February 14, 2023 - NEW PRODUCT

Glossary

Term Definition
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.