Generic Natazia Availability

Natazia is a brand name of dienogest/estradiol, approved by the FDA in the following formulation(s):

NATAZIA (dienogest; estradiol valerate - tablet;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: May 6, 2010
    Strength(s): N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A [RLD]

Has a generic version of Natazia been approved?

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

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

  • Combination compound for contraception based on natural estrogen
    Patent 6,133,251
    Issued: October 17, 2000
    Inventor(s): Dittgen; Michael & Fricke; Sabine & Hoffmann; Herbert & Moore; Claudia & Oettel; Michael & Ostertag; Monika
    Assignee(s): Jenapharm GmbH & Co. KG
    The combination preparation for contraception includes a first stage of 2 to 4 first stage daily dosage portions, a second stage of two groups of second stage daily dosage portions, a third stage of 2 to 4 third stage daily dosage portions and an additional stage of 2 to 4 additional stage daily dosage portions. The first stage daily dosage portion is an effective amount of natural estrogen, the second stage daily dosage portion is an effective amount of a combination of natural estrogen and natural or synthetic gestogen, the third stage daily dosage portion is another effective amount of natural estrogen and an additional stage daily dosage portion consists of a placebo. The first group of the second stage consists of 3 to 5 daily dosage portions and the second group, 13 to 17 daily dosage portions. More of the gestogen is included in the effective amount in the second group of the second stage than in the first group. The effective amount of the natural estrogen is constant in both the first and third stages, but smaller in the third stage than in the first stage.
    Patent expiration dates:
    • October 25, 2016
      ✓ 
      Patent use: PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • October 25, 2016
      ✓ 
      Patent use: CONTRACEPTION
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • October 25, 2016
      ✓ 
      Patent use: PREVENTION OF PREGNANCY
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
  • Combination preparation for contraception based on natural estrogens
    Patent 6,884,793
    Issued: April 26, 2005
    Inventor(s): Dittgen; Michael & Fricke; Sabine & Hoffmann; Herbert & Moore; Claudia & Oettel; Michael & Ostertag; Monika
    Assignee(s): Jenapharm GmbH & Co. KG
    The combination preparation for contraception includes from 2 to 4 first stage daily dosage portions each including an effective amount of at least one natural estrogen as sole active ingredient, from 16 to 22 second stage daily dosage portions each including an effective amount of a combination of at least one natural estrogen and at least one natural or synthetic gestogen as active ingredient; from 2 to 4 third stage daily dosage portions each including an effective amount of at least one natural estrogen as sole active ingredient; and from 2 to 4 final stage daily dosage portions containing a pharmaceutically acceptable placebo. The estrogen may be estradiol, an estradiol compound that is metabolized to estradiol when taken into the body, a conjugated equine estrogen or a phytoestrogen. The natural or synthetic gestogen can be natural progesterone or a synthetic gestogens, such as medroxyprogesterone acetate.
    Patent expiration dates:
    • October 25, 2016
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
  • Multi-phase contraceptive preparation based on a natural estrogen
    Patent 8,071,577
    Issued: December 6, 2011
    Inventor(s): Endrikat; Jan & Duesterberg; Bernd
    Assignee(s): Bayer Pharma Aktiengesellschaft
    The multiphase preparation having higher contraceptive safety and reduced side effects is based on a combination of a natural oestrogen with dienogest or drospirenone. The multiphase preparation is characterized by a first phase consisting of 2 daily dose units of 3 mg of oestradiol valerate, a second phase consisting of 2 groups of daily dose units, wherein a first group is formed by 5 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least two or three times an ovulation-inhibitory dose of dienogest or drospirenone and a second group is formed by 17 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least three or four times the ovulation-inhibitory dose of dienogest or drospirenone, a third phase consisting of 2 daily dose units of 1 mg of oestradiol valerate, and a further phase consisting of 2 daily dose units of pharmaceutically acceptable placebo.
    Patent expiration dates:
    • May 13, 2026
      ✓ 
      Patent use: PREVENTION OF PREGNANCY
      ✓ 
      Drug product
  • Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same
    Patent 8,153,616
    Issued: April 10, 2012
    Inventor(s): Zeun; Susan & Boudes; Pol & Secci; Angelo & Nedrikat; Jan & Zimmermann; Holger
    Assignee(s): Bayer Pharma Aktiengesellschaft
    The multiphase combination preparation for oral therapy of dysfunctional uterine bleeding and for oral contraception contains a first phase consisting of 2 daily dosage units, each containing 3 mg of estradiol valerate or <3 mg of estradiol; a second phase consisting of a first group of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol, and a second group consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol; a third phase consisting of 2 daily dosage units, each containing 1 mg of estradiol valerate or <1 mg of estradiol; and another phase consisting of 2 daily dosage units of a pharmaceutically harmless placebos.
    Patent expiration dates:
    • January 30, 2028
      ✓ 
      Patent use: TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

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:
    • March 14, 2015 - TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

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.
Hide
(web1)