QTERNMET XR Drug Patent Profile

When do Qternmet Xr patents expire, and when can generic versions of Qternmet Xr launch?

Qternmet Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and ninety-two patent family members in forty-eight countries.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six 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 Qternmet Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 12, 2031. This may change due to patent challenges or generic licensing.

There have been eighteen 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 QTERNMET XR

International Patents:	292
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QTERNMET XR
DailyMed Link:	QTERNMET XR at DailyMed

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

Constraining patent/regulatory exclusivity:

9,616,028*PED

NDA:

210874

Dosage:

TABLET, EXTENDED RELEASE;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.

US Patents and Regulatory Information for QTERNMET XR

QTERNMET XR is protected by five US patents.

This potential generic entry date is based on patent 9,616,028.

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
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	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	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y

Expired US Patents for QTERNMET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	6,414,126

International Patents for QTERNMET XR

When does loss-of-exclusivity occur for QTERNMET XR?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

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 QTERNMET XR 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
Australia	2003237886	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD

Supplementary Protection Certificates for QTERNMET XR

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
1506211	92182	Luxembourg		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES

Last updated: June 6, 2026

QTERNMET XR Market Dynamics and Financial Trajectory: Sales Mix, Pricing Pressure, Exclusivity Timeline, and Generic/Biosimilar Risk

QTERNMET XR is an extended-release formulation marketed in the US as a single-brand product. Public market-dynamics and financial-trajectory assessment depends on (i) the specific QTERNMET XR active ingredient strength(s), (ii) the FDA approval and Orange Book listing for the exact NDC(s) sold, and (iii) company-reported and payer-reported sales by fiscal quarter. Without those identifiers, an accurate, data-backed revenue and exclusivity timeline cannot be produced.

What is QTERNMET XR’s FDA status and Orange Book listing status?

Featured snippet answer: QTERNMET XR’s exclusivity, patent coverage, and generic entry risk cannot be determined without the exact FDA application reference (NDA/ANDA/BLA) and the Orange Book listings tied to the marketed NDC(s).

What is the FDA approval pathway for QTERNMET XR?

• Approval pathway (NDA vs 505(b)(2) vs supplement) determines patent eligibility for exclusivity and the likely scope of method-of-use or formulation IP.

Which Orange Book patents list for QTERNMET XR?

• The Orange Book “patent numbers” and “claim types” (drug substance, drug product, method of use) drive Paragraph IV strategies and settlement patterns.

How does QTERNMET XR’s exclusivity interact with REMS and labeling?

• REMS requirements can constrain supply and contracting dynamics, changing effective access and payer adoption.

When does QTERNMET XR lose exclusivity and patent protection?

Featured snippet answer: A reliable exclusivity and patent-expiration timeline requires the Orange Book patent family for the exact QTERNMET XR NDC(s) and the FDA reference listed drug (RLD).

What are the key exclusivity clocks for QTERNMET XR?

• New chemical entity (NCE) or 505(b)(2) exclusivities
• Pediatric exclusivity extension (if granted)
• Orphan drug exclusivity (if applicable)
• 3-year/5-year carve-outs based on approval route

What patent expiration dates matter most for revenue protection?

• Drug product/formulation patents often govern extended-release performance and bioequivalence carve-outs.
• Method-of-use patents can delay generic labeling expansions and limit substitution.

What patents protect QTERNMET XR extended-release formulations?

Featured snippet answer: Patent coverage for extended-release dosage forms is typically split between formulation, matrix technology, dissolution profile, and manufacturing processes.

What formulation patent claim types can block generics?

• Controlled-release polymers or coatings
• Bead or matrix composition and ratio ranges
• Release-rate and in vitro dissolution windows
• Bioavailability and pharmacokinetic targets

What manufacturing-process patents can create IP barriers?

• Granulation, compression, coating, and extrusion conditions
• In-process controls linked to dissolution endpoints

What generic entry risks exist for QTERNMET XR?

Featured snippet answer: Generic entry risk depends on whether QTERNMET XR has active Paragraph IV litigation or whether ANDA filers can carve around specific patent claim types.

Do any Paragraph IV challenges target QTERNMET XR patents?

• Paragraph IV waves typically coincide with patent-expiration proximity and can trigger 180-day exclusivity for the first filer.

What “at-risk” launch scenarios exist?

• Full-launch vs launch with authorized generic
• Carve-out label territories if method-of-use protection remains

How does payer policy affect substitution risk?

• Formulary switching is usually slower when the product is a preferred brand or when ER dosing reduces adherence failures.

What patent litigation affects QTERNMET XR and who is likely to challenge it?

Featured snippet answer: Litigation risk cannot be mapped without the specific patent numbers and docketed disputes linked to QTERNMET XR’s Orange Book listings.

Which companies typically challenge XR products?

• Mid-sized ANDA players pursue ER generics when formulation patents are narrow or time-to-expiration aligns with filing windows.

What settlement terms control launch timing?

• “Type of settlement” (no-180-day forfeiture vs market-share optimization)
• Launch date commitments and injunction triggers

How do QTERNMET XR’s market dynamics compare with similar extended-release drugs?

Featured snippet answer: Competitive dynamics for ER products are usually shaped by (i) adherence and dosing convenience, (ii) formulary position (tiering), and (iii) side-effect and switching tolerability.

What competitive levers typically move share in ER classes?

• Copay design and patient support programs
• Net price trajectory vs rebates
• Contracting with PBMs and integrated delivery networks

Which delivery system differences change payer behavior?

• ER vs IR dosing frequency
• Tablet vs capsule vs sprinkle formulations
• Food effects and titration complexity

What is the reimbursement and pricing trajectory for QTERNMET XR?

Featured snippet answer: A pricing and reimbursement trajectory requires NDC-level reimbursement data, PBM contract disclosures, and financial commentary from the marketer or payer-reported net pricing.

How do rebates and discounts affect net price?

• Net price is driven by formulary access, volume commitments, and utilization controls.

How do therapeutic interchange rules affect effective price?

• State and plan policies can accelerate or slow substitution, shifting realized pricing.

What are the key financial indicators and revenue drivers for QTERNMET XR?

Featured snippet answer: A financial trajectory view requires reported quarterly sales, segment reporting, and guidance that ties to net sales and gross-to-net metrics for QTERNMET XR specifically.

What drives gross-to-net for brand ER products?

• Rebates (PBM and government)
• Chargebacks
• Managed market access agreements

What matters for operating leverage?

• Manufacturing cost of goods for ER technologies
• Supply stability and returns
• R&D and lifecycle management (line extensions, reformulations)

What commercial risks compress margins first?

• Early competitor entry
• Steeper rebate pressure after formulary repositioning
• Authorized generic availability

Key exclusivity, regulatory, and launch timeline for QTERNMET XR

Featured snippet answer: A precise timeline cannot be generated without the exact Orange Book patent set for the sold QTERNMET XR NDC(s).

Timeline framework to populate once NDC-level identifiers are known

• FDA approval date (initial NDA and supplements)
• Orange Book patent expiration dates by claim type
• Exclusivity expiration (if awarded)
• Expected generic launch windows based on patent sets and litigation schedules

What “timing deltas” usually matter in practice?

• 180-day exclusivity triggers tied to first ANDA approval
• Carve-out label strategies that can still allow substitution earlier than full patent expiry

Which data sources typically quantify QTERNMET XR’s market share and revenue?

Featured snippet answer: Revenue and market share typically come from payer and market databases plus issuer financial disclosures.

Commercial sales sources

• Company quarterly and annual filings
• IQVIA/IMS prescription data (channel and geography)
• Government purchase benchmarks (if relevant)

Patent and litigation sources

• FDA Orange Book
• FDA “Drugs@FDA”
• Dockets and court filings for Paragraph IV disputes

Key takeaways

No data-backed market-dynamics or financial trajectory assessment for QTERNMET XR can be produced without NDC-level FDA and Orange Book identifiers tied to the marketed product. Once the exact approved reference product and patent listings are identified, the revenue risk model should be built around: (i) patent-expiration by claim type, (ii) Paragraph IV and settlement status, (iii) formulary positioning and net pricing pressure, and (iv) ER-specific substitution barriers.

FAQs

1. How do ER formulation patents change generic launch timing for QTERNMET XR?
2. What Orange Book claim types (drug substance, drug product, method of use) most often delay QTERNMET XR generics?
3. How do PBM rebate structures typically affect net price trajectory for QTERNMET XR after formulary shifts?
4. What are the common settlement patterns when an ANDA filer challenges an XR patent estate?
5. How should investors model QTERNMET XR revenue risk near patent expiration windows?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.