DUAVEE Drug Patent Profile

Which patents cover Duavee, and when can generic versions of Duavee launch?

Duavee is a drug marketed by Wyeth Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-two patent family members in twenty countries.

The generic ingredient in DUAVEE is bazedoxifene acetate; estrogens, conjugated. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bazedoxifene acetate; estrogens, conjugated profile page.

DrugPatentWatch^® Generic Entry Outlook for Duavee

Duavee was eligible for patent challenges on October 13, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUAVEE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	14
Drug Prices:	Drug price information for DUAVEE
What excipients (inactive ingredients) are in DUAVEE?	DUAVEE excipients list
DailyMed Link:	DUAVEE at DailyMed

See drug prices for DUAVEE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUAVEE

NDA:

022247

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DUAVEE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
VA Office of Research and Development	Phase 2
Penn State University	Phase 4
The John B. Pierce Laboratory	Phase 4

See all DUAVEE clinical trials

Pharmacology for DUAVEE

Drug Class	Estrogen Agonist/Antagonist Estrogen
Mechanism of Action	Estrogen Receptor Agonists Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for DUAVEE

DUAVEE is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y

Expired US Patents for DUAVEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013

International Patents for DUAVEE

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

Country	Patent Number	Title	Estimated Expiration
Argentina	011503	DERIVADOS DE 2-FENIL-1-[4-(2-AMINOETOXI)-BENCIL]-INDOL, UN PROCESO PARA SU PREPARACION ,COMPOSICION FARMACEUTICA QUE LOS CONTIENE Y USO DEL MISMO PARA PREPARAR COMPOSICIONES FARMACEUTICAS
Austria	206701
Australia	1892097
Australia	710149
Brazil	9701895	agentes estrogênicos e composição farmacêutica compreendendo os mesmos.

Supplementary Protection Certificates for DUAVEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	PA2009007	Lithuania		PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
0802183	CA 2009 00035	Denmark
0802183	91608	Luxembourg		91608, EXPIRES: 20220415
0802183	300416	Netherlands		300416, 20170415, EXPIRES: 20220414
0802183	PA2009007,C0802183	Lithuania		PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417

Last updated: July 22, 2026

Duavee market dynamics and financial trajectory (sales, drivers, exclusivity, and generic/biosimilar risk)

Duavee (conjugated estrogens/bazedoxifene; CEE/BAZ, 0.45 mg/20 mg tablets) is a branded, oral tissue-selective estrogen/estrogen-receptor modulator combination used for prevention of osteoporosis in postmenopausal women with uterine presence and for moderate vasomotor symptoms. Its revenue profile is shaped by: (1) the finite population eligible for long-term therapy with uterine status, (2) competition from cheaper generic estrogens, SERMs, and alternative hormonal regimens, and (3) the absence of biologics-style substitution, which keeps the threat mostly in the form of small-molecule generics and potential product-hop reformulations.

High-level financial trajectory: Duavee’s branded sales are expected to trend down as branded exclusivity ends and generic versions enter or threaten substitution. Near-term demand is more sensitive to women’s health prescribing patterns, formulary positioning, and payer utilization management than to clinical breakthroughs, because the drug class is mature.

Key business actions: Track FDA Orange Book listings for Duavee’s active ingredients and dosage strengths; map the remaining patent and exclusivity estate; monitor generic product submissions and any Paragraph IV litigation that could shift launch timing.

No specific sales figures, segment revenue history, or dated forecasts can be provided because the underlying dataset (FDA Orange Book entries for Duavee and a reliable branded sales history feed) is not included in the prompt.

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What is Duavee’s market size and demand drivers in postmenopausal women?

Duavee targets a defined intersection of needs:

• Moderate vasomotor symptoms associated with menopause (hot flashes).
• Prevention of osteoporosis in postmenopausal women at risk, including those with a uterus, where endometrial protection is a central formulation/therapy requirement.

Who is the addressable prescriber and patient base?

Demand depends on:

• Gynecology and primary care prescribing of menopausal hormone therapy (MHT).
• Persistence on long-term osteoporosis prevention regimens.
• Patient selection where uterine presence makes endometrial safety a key decision point.

What drives day-to-day prescribing?

• Payer coverage: plan formularies and prior authorization.
• Copay and utilization management: branded vs generic substitution rules at the pharmacy level.
• Switching behavior: once patients stabilize, persistence can stay higher than for short-cycle therapies, but payers can still steer.

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How do competitor hormonal therapies affect Duavee pricing power and volume?

Duavee competes in the menopausal therapy market where alternatives include:

• Generic estrogens (for vasomotor symptoms and often osteoporosis prevention depending on regimen).
• Other SERMs and estrogen combinations used for osteoporosis prevention strategies.
• Non-SERM osteoporosis agents (where prescriptions shift toward non-estrogen mechanisms).
• Different hormonal delivery routes (transdermal, local therapies) that can capture patients with tolerability preferences.

What is the competitive mechanism that matters most?

Most competitive pressure comes from coverage and price:

• If payers make generic estrogen options cheaper with fewer restrictions, Duavee’s incremental value must clear higher thresholds.
• If formularies restrict SERMs or specific combinations, Duavee faces formulary churn even when clinical fit is strong.

How does uterine status shape substitution risk?

Uterine status limits “free substitution” for estrogen-only therapies that require endometrial protection. Duavee’s combination positioning reduces the barrier to safety-appropriate prescribing. However:

• Endometrial protection can be achieved with other regimens, including progestin-based approaches, which can still be cheaper and thus used under payer pressure.

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What patents protect Duavee and how strong is the remaining patent estate?

Duavee’s protection typically spans:

• Composition-of-matter and combination claims for CEE/BAZ.
• Formulation and dosage form claims (tablet composition, dissolution, specific formulation parameters).
• Method-of-use claims tied to vasomotor symptoms and osteoporosis prevention.
• Potential manufacturing process claims.

Patent strength signals that affect business outcome:

• How many distinct families exist across the active ingredient combination.
• Whether claims are likely to be invalidated or designed around by generic manufacturers.
• Whether Orange Book lists additional patents beyond the core product claims.

No specific patent numbers, family counts, or expiry dates can be listed without the Duavee Orange Book record and the patent document set, which are not present in the prompt.

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When does Duavee lose exclusivity and what is the generic entry timeline?

Duavee’s exclusivity outcomes depend on:

• Regulatory exclusivity (new chemical entity or new combination exclusivity rules where applicable).
• Patent expiry for listed patents in the Orange Book.
• Whether generics file ANDAs with Paragraph IV certifications.

What timing events usually matter for market entry?

• Patent expiry or invalidation that removes the ability to launch without violating listed claims.
• Settlement agreements, if any, that delay or structure entry.
• FDA approval timelines following submission and review.

No specific exclusivity calendar can be produced without Duavee’s Orange Book list and corresponding patent expiry dates.

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What is the Orange Book status of Duavee and which strengths are listed?

Orange Book status is determined by:

• Listed patents tied to the specific NDA and dosage strengths.
• Whether patents are listed for the same strength (0.45 mg/20 mg) or across multiple strengths/variants.

What to extract for competitive monitoring

• Patent list count by family.
• Expiration dates by patent.
• Any pediatric exclusivity, if applicable to the NDA.
• Whether the listed patents include formulation vs method-of-use categories.

The prompt does not include the Orange Book dataset, so no field-accurate Orange Book listings can be provided.

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Which Paragraph IV challenges could threaten Duavee’s market exclusivity?

Generic threat for a branded small-molecule like Duavee usually appears via:

• ANDA filings with Paragraph IV certifications against listed Orange Book patents.
• Potential litigation in federal court that can lead to:
  • 30-month stay (if triggered),
  • injunctions,
  • or settlement-driven launch dates.

What litigation signals usually move the revenue curve

• A Paragraph IV ANDA that targets multiple listed patents.
• Court rulings sustaining a subset of patents or invalidating others.
• Settlements that impose structured delay.

No claim-level litigation status or specific Paragraph IV case details can be provided without a dataset of Duavee’s ANDA filings and court dockets.

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What formulations are protected for Duavee tablets and how does that affect generic design?

Generic entry for combination products depends on:

• Bioequivalence requirements: generic must match systemic exposure measures (AUC/Cmax) for both components.
• Formulation design-around: if formulation patents exist, generics may need alternative excipients, processing, or dissolution profiles.

What manufacturing/IP barriers usually matter

• Proprietary manufacturing parameters that control tablet uniformity and dissolution.
• Use of specific excipient systems that could be protected by formulation claims.

No Duavee formulation patent coverage can be quantified without the Orange Book patent list and corresponding patent documents.

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How does Duavee’s market performance compare with other menopause and osteoporosis branded therapies?

Duavee’s relative performance is shaped by:

• Whether competitors offer stronger payer relationships.
• Whether the market shifts to lower-cost osteoporosis agents that reduce overlap with estrogen-based prevention.
• Patient preference for routes of administration and tolerability.

Where Duavee can win

• Clear clinical fit where uterine protection is required without progestin-based regimens.
• Simpler oral regimen adherence compared with some multi-step strategies.

Where Duavee can lose

• Aggressive generic substitution of alternative hormonal options.
• Formularies that prefer low-cost osteoporosis agents outside estrogen prevention frameworks.

No comparative revenue metrics can be listed without a sales database. The prompt does not provide branded sales history for Duavee or comparator brands.

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What FDA regulatory pathway governs Duavee generics and what does it imply for timing?

Duavee is a small-molecule oral drug. Generic entry is expected via:

• ANDA with Abbreviated approval and bioequivalence.
• Potential 505(j) filings for generic substitution subject to Orange Book constraints.

Regulatory milestones that affect launch

• ANDA acceptance and review cycle.
• Patent-related litigation outcomes and stays.
• FDA labeling and bioequivalence confirmation.

No pathway-specific filing timelines can be stated without ANDA status data.

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Commercial risk: what generic launch scenarios exist for Duavee and how would they impact revenue?

Revenue impact typically scales with:

• Number of generic entrants at first launch.
• Speed of payer uptake after approval.
• Formulary replacement and switching rates.

Three common launch scenarios

1. Single first entrant: slower price erosion; residual branded sales persist on payer formularies with remaining restrictions.
2. Multiple rapid entrants: steeper price and volume decline; branded revenue falls faster.
3. Entry blocked by patent or settlement: delayed erosion; revenue stays flatter until the next launch trigger.

No scenario probabilities can be computed without patent expiry calendars, litigation outcomes, and ANDA acceptance/approval status.

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What business decisions should be made based on Duavee’s likely financial trajectory?

For R&D, licensing, and investment planning, the actionable framework is:

• Map the patent-by-patent expiry to build launch-risk bands (e.g., 0 to 12 months, 12 to 24 months, 24 to 36 months).
• Track Paragraph IV filings to identify the earliest credible market-entry dates.
• Monitor formulary movement via pharmacy benefit manager contracting and utilization trends post-approval of generics.

Specific recommendations tied to named patents, court cases, or forecast dates cannot be delivered without the Orange Book and litigation inputs.

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Key Takeaways

• Duavee’s market dynamics are driven more by payer policy, switching behavior, and the economics of competing hormone/Osteoporosis regimens than by biologic-style substitution.
• Generic risk is the dominant exclusivity threat pathway, through ANDAs and Paragraph IV challenges against Orange Book-listed patents.
• The financial trajectory is expected to follow an exclusivity-to-erosion pattern typical for branded oral hormone/SERM combination therapies, with the steepness depending on patent fragmentation, litigation outcomes, and speed of generic adoption.
• The business priority is to maintain a live map of Duavee Orange Book patents, expiry dates, and any Paragraph IV litigation that can re-time the entry curve.

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FAQs

1. What proportion of Duavee demand comes from vasomotor symptom indications versus osteoporosis prevention?
Cannot be answered from the information provided.

2. Do Duavee’s patents cover only the combination, or also tablet formulation and manufacturing processes?
Cannot be answered without the Orange Book patent list and associated patent documents.

3. What is the typical revenue erosion profile after generic entry for menopausal therapy brands?
Cannot be quantified without Duavee-specific historical sales and comparator data.

4. Are there biosimilar risks for Duavee?
No, Duavee is a small-molecule drug; substitution risk is expected through generic ANDAs, not biosimilars.

5. How does uterine status constrain generic substitution and labeling for Duavee?
Cannot be stated precisely without Duavee label details and the generic labeling constraints tied to patents and exclusivity.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (No Duavee listing content was provided in the prompt.)
2. Drugs@FDA. U.S. Food and Drug Administration. (No Duavee regulatory milestones were provided in the prompt.)

DrugChatter Q&A for DUAVEE

Goodrx duavee 30 tablets price?
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