Natazia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 4 US drug patents filed in 2013. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2028. Details of Natazia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8153616 | Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same |
Jan, 2028
(2 years from now) | Active |
| US8071577 | Multi-phase contraceptive preparation based on a natural estrogen |
May, 2026
(11 months from now) | Active |
| US6884793 | Combination preparation for contraception based on natural estrogens |
Oct, 2016
(8 years ago) |
Expired
|
| US6133251 | Combination compound for contraception based on natural estrogen |
Oct, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Natazia's patents.
Latest Legal Activities on Natazia's Patents
Given below is the list of recent legal activities going on the following patents of Natazia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Sep, 2023 | US8153616 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2023 | US8071577 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Sep, 2019 | US8153616 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 May, 2019 | US8071577 |
| Expire Patent Critical | 19 May, 2017 | US6884793 |
| Post Issue Communication - Certificate of Correction | 05 Jun, 2013 | US8153616 |
| Mail-Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 06 May, 2013 | US8153616 |
| Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 06 May, 2013 | US8153616 |
| Petition Entered | 26 Dec, 2012 | US8153616 |
| Post Issue Communication - Certificate of Correction Denied | 12 Dec, 2012 | US8153616 |
FDA has granted several exclusivities to Natazia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Natazia, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Natazia.
Exclusivity Information
Natazia holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Natazia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 06, 2013 |
| New Indication(I-648) | Mar 14, 2015 |
Several oppositions have been filed on Natazia's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Natazia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Natazia patents.
Natazia's Oppositions Filed in EPO
Natazia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 26, 2009, by Sandoz International Gmbh. This opposition was filed on patent number EP05022324A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05730867A | Apr, 2011 | Lupin Limited | Patent maintained as amended |
| EP05730867A | Apr, 2011 | Laboratorios Léon Farma, S.A. | Patent maintained as amended |
| EP05022324A | Nov, 2009 | Sandoz International GmbH | Revoked |
US patents provide insights into the exclusivity only within the United States, but Natazia is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Natazia's family patents as well as insights into ongoing legal events on those patents.
Natazia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Natazia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Natazia Generic API suppliers:
Dienogest; Estradiol Valerate is the generic name for the brand Natazia. 1 company has already filed for the generic of Natazia. Check out the entire list of companies who have already received approval for Natazia's generic
How can I launch a generic of Natazia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Natazia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Natazia's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Natazia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg | 22 Oct, 2010 | 1 | 25 Oct, 2016 | Extinguished |
Alternative Brands for Natazia
Natazia which is used for preventing pregnancy and treating heavy menstrual bleeding in women who use oral contraceptives., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil |
| |||||||||||
| Bayer Hlthcare |
| |||||||||||
| Evofem Inc |
| |||||||||||
| Organon |
| |||||||||||
| Teva Branded Pharm |
| |||||||||||
| Wyeth Pharms Inc |
| |||||||||||
About Natazia
Natazia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for preventing pregnancy and treating heavy menstrual bleeding in women who use oral contraceptives. Natazia uses Dienogest; Estradiol Valerate as an active ingredient. Natazia was launched by Bayer Hlthcare in 2010.
Approval Date:
Natazia was approved by FDA for market use on 06 May, 2010.
Active Ingredient:
Natazia uses Dienogest; Estradiol Valerate as the active ingredient. Check out other Drugs and Companies using Dienogest; Estradiol Valerate ingredient
Treatment:
Natazia is used for preventing pregnancy and treating heavy menstrual bleeding in women who use oral contraceptives.
Dosage:
Natazia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | TABLET | Prescription | ORAL |