NATAZIA Drug Patent Profile

Which patents cover Natazia, and what generic alternatives are available?

Natazia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in thirty-nine countries.

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

DrugPatentWatch^® Generic Entry Outlook for Natazia

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dienogest; estradiol valerate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NATAZIA

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	35
Drug Prices:	Drug price information for NATAZIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NATAZIA
What excipients (inactive ingredients) are in NATAZIA?	NATAZIA excipients list
DailyMed Link:	NATAZIA at DailyMed

See drug prices for NATAZIA

See drug sales revenues for NATAZIA

Paragraph IV (Patent) Challenges for NATAZIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NATAZIA	Tablets	dienogest; estradiol valerate	3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg	022252	1	2010-10-22

US Patents and Regulatory Information for NATAZIA

NATAZIA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,153,616
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,071,577		Y

Expired US Patents for NATAZIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,133,251
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	8,071,577
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,884,793

International Patents for NATAZIA

See the table below for patents covering NATAZIA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	164312
Canada	2188907	COMPOSE POUR CONTRACEPTION BASEE SUR LES OESTROGENES NATURELS (COMBINATION COMPOUND FOR CONTRACEPTION BASED ON NATURAL ESTROGEN)
China	1137691
China	1159917
Czech Republic	290741	Vícefázový prostředek pro antikoncepci (Multiphase preparation for contraception)

Supplementary Protection Certificates for NATAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	CA 2009 00016	Denmark
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	91643	Luxembourg		91643, EXPIRES: 20211022
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208

Last updated: July 26, 2026

NATAZIA (levonorgestrel and ethinyl estradiol) market dynamics and financial trajectory: sales, competition, and exclusivity risk

NATAZIA is a combined oral contraceptive (COC) in the US marketed by Xellia Pharmaceuticals. Key financial read-through: the product faces ongoing generic pressure typical for COCs, with long-run revenue shaped less by patent exclusivity and more by formulary access, wholesaler inventory cycles, and payer switching among AB-rated generics. Post-launch trajectory for NATAZIA is driven by small share dynamics and the degree to which prescribers remain on brand versus AB substitution.

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How has NATAZIA performed financially in the US market?

Answer (commercial): Public market visibility for NATAZIA is limited compared with large estrogen-progestin brands. Revenue trajectories for COCs at this scale generally follow a pattern: brand peak is followed by accelerated share loss once multiple AB-rated generics consolidate at low net prices.

Where to look for actual financials

• Xellia segment reporting: NATAZIA sales are typically embedded in broader US or specialty women’s health reporting rather than disclosed as a standalone line item.
• Third-party pharmacy datasets (IQVIA/NPIs-based): track NDC volume and net price by payer/retail channel, which is where revenue trend lines usually become visible for smaller brands.

Expected financial inflection drivers

• Wholesale fill-and-pull cycles (inventory turns at large distributors).
• Formulary and prior authorization placement (commercial and Medicaid managed care).
• Patient switching due to copay differentials and pharmacy benefit design.
• Margin compression from generic entry and increased rebates to maintain access.

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What is the competitive landscape for NATAZIA versus generic oral contraceptives?

Answer (competition): NATAZIA competes with AB-rated generic levonorgestrel/ethinyl estradiol COCs and multiple alternative COCs across payers. Competitive pressure is structural because COCs are highly substitutable and most states allow pharmacy-level substitution.

Key competitive vectors

1. Net price pressure

   • Generic COCs establish a low anchor price.
   • Brand pricing only holds if rebates and access terms neutralize the copay gap.

2. Payer preference for preferred generics

   • Formularies often position one or two generic NDCs as preferred tiers.
   • Brands like NATAZIA must win access on remaining non-preferred tiers or via restricted member criteria.

3. Channel mix

   • Mail-order and large retail chains tend to emphasize lowest-cost alternatives under PBM contracts.
   • Specialty pharmacies rarely matter for typical COCs unless a managed-care restriction applies.

Commercial risk summary

• For a COC brand, the dominant long-run revenue risk is not trial demand but rate of switching to lower-cost AB alternatives.

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What market dynamics drive demand for NATAZIA (COC category effects)?

Answer (demand): Demand for COCs in the US tracks primarily to women’s health utilization, adherence behavior, and contraceptive insurance design, not to incremental clinical differentiation.

Category-level demand factors

• Contraception utilization cycle: birth control demand is sensitive to demographics, pregnancy rates, and contraceptive counseling patterns.
• Adherence and discontinuation: COCs require daily adherence; early discontinuation drives churn and switching.
• Plan design: copay tiers and annual deductibles materially shift “brand vs generic” behavior.

NATAZIA-specific demand sensitivity

• As with other small-to-mid brands, NATAZIA volume often depends on:
  • prescriber familiarity
  • pharmacist substitution rules at the chain level
  • payer-specific step therapy or non-preferred positioning

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When does NATAZIA lose exclusivity, and how does that affect revenue?

Answer (timing): A complete exclusivity timeline cannot be reliably produced without the underlying Orange Book patent and exclusivity records for the specific NATAZIA NDA. Generic COCs typically face earlier practical erosion from paragraph IV-style filings and AB substitution even before the last listed patent, depending on Orange Book coverage and settlement outcomes.

Commercial effect to model

• Revenue often shows a two-stage decline:
  1. Pre-erosion: loss of new scripts as payers tighten preferred tiers
  2. Post-erosion: inventory and switch acceleration after generic consolidation in channel

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What is the Orange Book status of NATAZIA and which patents matter for generic entry?

Answer (legal/IP): A definitive count of listed patents and their expiration dates cannot be stated here without the specific FDA Orange Book listing tied to NATAZIA’s NDA.

How to interpret Orange Book impact for COCs

• Even when patents remain, AB-rated generics can still enter via:
  • expiration of relevant formulation/compound coverage
  • carve-outs and non-infringement positions
  • settlement that permits earlier launch under agreed terms
• In COCs, the practical barrier to generic revenue capture is often formulary control, not patent duration alone.

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Are there Paragraph IV challenges or generic launch risks for NATAZIA?

Answer (generic risk): NATAZIA likely faces AB substitution and potential ANDA entry risks common to COCs, but a precise assessment of Paragraph IV activity and launch timing requires the FDA ANDA litigation and Orange Book–linked patent list.

Commercial implications if generics launch

• Net price typically falls sharply in the first 3 to 6 quarters post-launch.
• Brand volume drop is often faster than brand manufacturers expect, especially if one or more generics secure preferred formulary placement.

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What settlements or patent litigation affect NATAZIA’s market trajectory?

Answer (litigation): Specific settlement dates and terms cannot be provided without case identifiers linked to NATAZIA’s Orange Book patents and NDA.

Commercially relevant litigation outcomes in COCs

• Settlement agreements that allow early generic launch at a defined date.
• Stipulated interim switching restrictions that delay pharmacy adoption.
• “Skinny label” or design-around that reduces patent infringement exposure.

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How is NATAZIA regulated in the US (NDA status, FDA pathway, labeling)?

Answer (regulatory): NATAZIA is an FDA-approved COC under an NDA, with post-approval manufacturing and labeling requirements. As an established contraceptive product, its regulatory profile does not usually create major incremental timing risk compared with generics and reformulations.

Regulatory factors that impact commercial performance

• Label changes driven by safety communications can require pharmacist and prescriber education.
• Variations in manufacturing compliance can temporarily affect supply and sales in discrete quarters.

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What formulation or dosing attributes of NATAZIA protect it commercially?

Answer (commercial/formulation): COCs are often differentiated through dosing schedule, hormone strengths, and tablet regimen. In practice, however, generics can usually replicate the active ingredient profile and dosing schedule, so formulation protection tends to be limited once generic pathways are available.

Commercial relevance

• If NATAZIA’s dosing schedule maps cleanly to generic equivalents, the brand’s differentiation reduces to:
  • patient tolerance and clinician familiarity
  • supply continuity
  • contracting and rebates

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How does NATAZIA compare with other COCs in market structure and pricing power?

Answer (comparative): For COC brands in the US, pricing power is limited once multiple AB options exist. Brands with the longest survivability are usually those with:

• constrained generic competition (fewer AB equivalents)
• strong payer placement
• or niche prescriber retention

NATAZIA-specific read-through

• If competing generics are plentiful, NATAZIA’s revenue trajectory is dominated by channel discounting and persistence of non-preferred access.

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What manufacturing or supply-chain risks affect NATAZIA sales?

Answer (supply): Supply stability is a material variable for contraceptives because pharmacies reorder continuously and prescriber trust degrades quickly after stockouts.

Operational risk levers

• Contract manufacturing performance
• Packaging line constraints (bottles/blisters)
• Distributor fill rates and lot-level QA release timing

A stockout can temporarily lift competitor share and create a durable switching effect even after resupply.

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Key financial model for NATAZIA trajectory (what to forecast)

Because standalone public revenue figures are not reliably extractable here, the forecasting model should be built from observable market levers:

Revenue decomposition

• Units (scripts or tablets) by channel
• Net price by payer tier after rebates
• Contracting effects (tiering, step edits, preferred status)
• Generic share displacement after new entrants

Quarterly inflection checklist

• Formulary updates at major PBMs or state Medicaid
• Chain-level preferred brand switches
• New generic NDC introductions
• Any supply disruptions (NDC shortages)

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Key Takeaways

• NATAZIA’s market dynamics follow the US COC playbook: revenue is primarily shaped by payer placement, AB substitution, rebate economics, and channel switching.
• Long-run financial trajectory is exposed to generic competition even when patents exist, because pharmacy substitution and formulary design determine net retention.
• Practical exclusivity impact must be validated against Orange Book listings tied to NATAZIA’s NDA; without that record, precise exclusivity and launch-risk timelines cannot be stated.
• Forecasting should be driven by units and net price decomposition, with close monitoring of formulary actions, PBM contracting, generic NDC entries, and supply continuity.

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FAQs

1) What is NATAZIA’s main competitive threat in the US?

Generic AB-rated levonorgestrel/ethinyl estradiol COCs that can capture preferred formulary positions and pharmacy substitution.

2) What drives NATAZIA net price changes quarter to quarter?

Rebate levels, payer contracting, tiering, and any formulary movement that shifts patient demand toward lower-cost AB alternatives.

3) Can NATAZIA lose market share without a patent expiration?

Yes. Payer tiering and PBM preference can reduce brand scripts before patent-relevant legal events, accelerating switching to generics.

4) Do COC supply issues have long-lasting sales effects?

Often. Stockouts can permanently change patient and prescriber behavior if pharmacies substitute and the plan covers the alternative.

5) What indicators best predict a brand COC revenue decline?

Generic NDC launches, formulary preference changes at PBMs, rising brand-to-generic copay differentials, and downward trends in retail and mail volume.

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References (APA)

No sources are cited because the required Orange Book, FDA label/NDA, ANDA litigation, and sales/market-access datasets for NATAZIA were not provided in the prompt.

DrugChatter Q&A for NATAZIA

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