QTERN Drug Patent Profile

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

Qtern is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in QTERN is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are two drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Qtern

Qtern was eligible for patent challenges on January 8, 2018.

There have been thirty 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.

Indicators of Generic Entry

Summary for QTERN

US Patents:	6
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	11
Drug Prices:	Drug price information for QTERN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QTERN
What excipients (inactive ingredients) are in QTERN?	QTERN excipients list
DailyMed Link:	QTERN at DailyMed

See drug prices for QTERN

Paragraph IV (Patent) Challenges for QTERN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	5 mg/5 mg	209091	1	2020-07-29
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	10 mg/5 mg	209091	5	2018-01-08

US Patents and Regulatory Information for QTERN

QTERN is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y

Expired US Patents for QTERN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	6,936,590
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	6,414,126
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019	RE44186
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	8,628,799

International Patents for QTERN

When does loss-of-exclusivity occur for QTERN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Chile

Denmark

European Patent Office

Japan

Mexico

Serbia

Slovenia

Taiwan

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

See the table below for additional patents covering QTERN around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	026024	COMPUESTOS INHIBIDORES SGLT2 DE GLUCOSIDOS DE C-ARILO Y METODO, LAS COMPOSICIONES FARAMCEUTICAS QUE LOS CONTIENEN Y LOS INTERMEDIARIOS DE SINTESIS DEDICHOS COMPUESTOS
Argentina	040032	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO
Austria	295848
Austria	353334

Supplementary Protection Certificates for QTERN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C300585	Netherlands		PRODUCT NAME: DAPAGLIFLOZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	PA2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	122013000033	Germany		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012

Last updated: May 27, 2026

QTERN (dapagliflozin/metformin extended-release) market dynamics and financial trajectory

QTERN, the fixed-dose combination of dapagliflozin and metformin extended-release (XR), is a U.S.-market product inside the broader SGLT2 inhibitor and metformin class competitive set. Its financial trajectory is driven by (1) SGLT2 demand growth and share shifts among dapagliflozin, empagliflozin, and ertugliflozin ecosystems; (2) formulary placement and payer steering based on A1c and cardiorenal indications; (3) generic and label-expansion timing for metformin XR and SGLT2 molecules; and (4) managed-entry dynamics for branded SGLT2 products and combination fixed-dose tablets.

This analysis maps the commercial mechanics that typically govern U.S. revenue for a late-stage branded combination and highlights the key IP and competitive pressure points that determine whether QTERN maintains share, declines, or is absorbed into payer-favored generics and alternative brand combinations.

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What is QTERN’s commercial positioning in the SGLT2 + metformin XR class?

QTERN’s role: fixed-dose adherence-focused product that pairs an SGLT2 inhibitor (dapagliflozin) with metformin XR, targeting type 2 diabetes patients needing both glucose lowering and a simplified regimen.

Where QTERN competes

QTERN competes against:

• Other dapagliflozin-based regimens (single-ingredient dapagliflozin + metformin XR, and other combination formats if present in-market).
• Competing SGLT2 + metformin combinations (different fixed-dose pairings within the same therapeutic adjacency).
• SGLT2 branded monotherapies/combos that win formulary preference based on payer contracting.
• Metformin generics plus branded SGLT2s once metformin XR is economically favorable on formularies.

Why fixed-dose combinations matter financially

Fixed-dose products typically win when payers and providers value:

• Reduced dosing complexity, which improves persistence
• Lower total copays vs separate prescriptions
• Clinical differentiation only when supported by guideline alignment and payer messaging

In practice, QTERN’s pricing power depends less on incremental pharmacology and more on formulary access relative to competing combos and the “branded SGLT2 + generic metformin” cost equation.

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How do formulary design and payer policies shape QTERN revenue?

Core mechanism: QTERN revenue is highly sensitive to payer step therapy and preferred drug lists (PDLs) across the SGLT2 class.

Payer levers that move demand

• Class-wide step therapy that makes SGLT2 eligibility contingent on metformin history or specific A1c thresholds.
• Prior authorization for combination products, especially if the plan allows inexpensive metformin generics plus a preferred SGLT2.
• Copay design that steers patients toward preferred SGLT2 molecules and away from non-preferred combinations.
• Network contracting that sets effective net prices via rebates tied to formulary tiering.

Featured snippet answer

QTERN financial performance tends to track payer favorability for dapagliflozin-based regimens and combination access. Revenue growth or stability usually requires maintaining preferred tier status versus the branded monotherapy and combination competitors.

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When does QTERN face generic erosion or brand substitution risk?

Generic erosion risk for the combination is driven by two lanes:

1. Metformin XR economics (metformin is largely generic; fixed-dose combo value erodes when payers prefer generic metformin).
2. SGLT2 ingredient exclusivity and derivative lifecycle (dapagliflozin brand protection determines the durability of the combination’s branded premium).

What typically accelerates substitution

• Expiration or weakening of protections specific to the fixed-dose combination product.
• Payer re-tiering that increases out-of-pocket costs for the combination tablet.
• Expansion of preferred SGLT2 options through contracting that narrows the net-price gap.

Commercial timing pattern

For fixed-dose combinations like QTERN, the most damaging demand shock is usually not a single patent expiry, but the combination of:

• SGLT2 molecule loss of market protection (when applicable)
• Contracting changes that favor generics or other preferred branded alternatives
• Switching by prescribers once cost barriers rise

(Determining exact launch and loss-of-exclusivity dates requires the Orange Book and patent docket for QTERN.)

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What patents protect QTERN and how does the patent estate affect financial durability?

Key point: A combination’s financial life depends on whether its protections cover the specific dose form, fixed-dose combination claims, and any method-of-use or formulation improvements.

Patent estate drivers for combination products

• Composition-of-matter coverage for the active ingredients (often long-lived but ingredient-specific).
• Combination-specific claims tied to fixed-dose ratios and dosage regimens.
• Formulation and manufacturing claims for XR release characteristics.
• Method-of-use claims for clinical indications (if pursued as drug-device or drug-benefit claims).

Featured snippet answer

QTERN’s financial durability depends on whether it retains enforceable claims specific to the fixed-dose combination and XR formulation, or whether exclusivity weakens into ingredient-level competition where payers steer patients to generic metformin plus the preferred SGLT2.

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What is the Orange Book status of QTERN and which filings create generic entry risk?

Orange Book status governs whether generic challengers can leverage FDA-described drug product patents and listing-driven Paragraph IV strategies.

What to check for entry risk

• Orange Book patent listings for QTERN: active ingredient, formulation, and method-of-use.
• Any generic ANDA submissions referencing QTERN with Paragraph IV certifications.
• Triggering events: court outcomes, settlement dates, and regulatory approvals.

Why this matters for the revenue trajectory

Generic entry risk converts into:

• Slower demand for branded QTERN ahead of launch
• Price competition after approvals
• Additional payer switching and channel inventory dynamics

(Exact status, listed patents, and any ANDA/Paragraph IV activity must be verified in Orange Book and related litigation dockets.)

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How strong is QTERN’s competitive position versus other SGLT2 + metformin products?

Competition outcome variables:

• Net price after rebates vs branded monotherapy options
• Formulary tier and patient access
• Prescriber familiarity and switching inertia
• Indication coverage and evidence used in payer policy

Comparison framework

Factor	QTERN impact mechanism	What it determines
Formulary tier	Preferred vs non-preferred	Volume growth or decline
Net price	Rebates and contracting	Margin and competitive ability
Fixed-dose adherence value	Reduced pill burden	Persistence and adherence-linked conversion
SGLT2 preferred molecule dynamics	Payer contracting within class	Share shift among dapagliflozin/alternatives
Combination vs “generic metformin + branded SGLT2”	Total cost to plan	Whether combination stays economically rational

Featured snippet answer

QTERN’s share is most threatened when payers conclude that cost minimization favors generic metformin plus the preferred SGLT2 monotherapy, shrinking the economic advantage of fixed-dose combinations.

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What litigation and settlements affect QTERN market exclusivity?

Financial relevance: settlements and court outcomes can accelerate or delay generic launch timelines and affect pre-launch contracting behavior.

Litigation categories to map

• Patent infringement suits involving QTERN Orange Book-listed patents
• Counterclaims tied to invalidity or non-infringement
• Settlement agreements that include launch date covenants

Commercial effect

• If courts or settlements reduce enforceable patent time, expect earlier payer switching and pharmacy stocking changes.
• If patent protection holds, brand makers often defend through contracting and patient-support programs.

(Actual QTERN litigation timelines require a patent and court docket review.)

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How do FDA labeling updates for dapagliflozin/metformin combinations shift QTERN demand?

Demand is influenced by:

• Label expansion into cardiorenal risk reduction categories
• Changes in guideline adoption for earlier use
• Safety communications that affect class prescribing patterns

What label changes typically do

• Increase “eligible patient” counts, expanding the addressable market
• Improve payer confidence to cover earlier-line therapy
• Trigger sequencing rule changes (e.g., SGLT2 earlier in treatment ladders)

Featured snippet answer

For SGLT2-based combinations, FDA label updates that broaden cardiorenal utility generally lift market demand for the whole class, but the incremental benefit to QTERN depends on whether payers prefer dapagliflozin-based fixed-dose options.

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Biosimilar risk: does it apply to QTERN?

QTERN is a small-molecule combination tablet, not a biologic. Biosimilar pathways and related exclusivity constraints do not apply.

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What generic entry scenarios threaten QTERN, and how quickly does share erode?

Entry scenario depends on whether generic or AB-rated versions can be marketed as fixed-dose combinations and whether the market permits substitution at the pharmacy level.

Typical post-launch share shape

• Early period: modest substitution if prescriber authorizations or PA requirements remain
• Mid period: stronger substitution as pharmacy and payer policies normalize
• Late period: additional switching once competing options gain tiering and inventory scale

Featured snippet answer

QTERN’s most material financial threat is fixed-dose combination competition or payer switching away from combination tablets toward “generic metformin + preferred SGLT2.”

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How does manufacturing and supply constrain QTERN growth?

Fixed-dose combinations can face:

• Scale and cost-of-goods headwinds
• Batch-release constraints for XR formulation
• Contract manufacturing switching costs

In mature markets, supply issues can cause short-term volume volatility, but long-run trajectory usually tracks formulary and competitive pricing.

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Market dynamics summary for QTERN: what moves revenue week-to-week and quarter-to-quarter

Quarterly revenue drivers typically include:

• Payer formulary updates and pharmacy channel tiering
• Net-price changes tied to contracting, rebates, and performance-based agreements
• Inventory buying patterns ahead of anticipated competitive entries
• Prescriber shift dynamics between fixed-dose combinations and monotherapy + metformin

Class-level tailwinds and headwinds are driven by:

• SGLT2 category growth trends
• Safety and tolerability perceptions (class-wide)
• Cardiorenal evidence adoption
• Competitor contracting intensity

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Key Takeaways

• QTERN is a branded SGLT2 + metformin XR fixed-dose tablet whose financial trajectory is driven mainly by payer contracting, formulary placement, and the economics of “combination vs generic metformin + preferred SGLT2.”
• The biggest revenue risk is structural brand-to-generic substitution once combination-specific protections weaken or payer strategies favor less expensive regimens.
• Exact exclusivity timing, generic entry triggers, and litigation-driven launch windows must be confirmed through Orange Book listings and Paragraph IV and litigation dockets tied to QTERN.
• Label expansions that expand eligible patients can lift the whole SGLT2 market, but QTERN share gains depend on whether payers prefer dapagliflozin-based combination products.

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FAQs

1. How does QTERN’s net price depend on SGLT2 formulary contracting and rebate structures?
2. What are the most common payer reasons for prior authorization denial for fixed-dose dapagliflozin/metformin XR products?
3. Does switching from separate prescriptions to QTERN improve adherence enough to affect payer coverage decisions?
4. Which SGLT2 competitor combination regimens most directly displace fixed-dose dapagliflozin/metformin XR on PDLs?
5. What Orange Book patent types (formulation vs method-of-use) most often determine QTERN generic launch timing?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. ANDA (Abbreviated New Drug Application) and Paragraph IV certification information and related resources. U.S. Food and Drug Administration.