GLUMETZA Drug Patent Profile

When do Glumetza patents expire, and what generic alternatives are available?

Glumetza is a drug marketed by Santarus Inc and is included in one NDA.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glumetza

A generic version of GLUMETZA was approved as metformin hydrochloride by CHARTWELL on January 24^th, 2002.

Summary for GLUMETZA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	51
Patent Applications:	38
Drug Prices:	Drug price information for GLUMETZA
Drug Sales Revenues:	Drug sales revenues for GLUMETZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLUMETZA
What excipients (inactive ingredients) are in GLUMETZA?	GLUMETZA excipients list
DailyMed Link:	GLUMETZA at DailyMed

See drug prices for GLUMETZA

See drug sales revenues for GLUMETZA

Recent Clinical Trials for GLUMETZA

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

Sponsor	Phase
Arthritis Foundation	Phase 2
Brigham and Women's Hospital	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all GLUMETZA clinical trials

Pharmacology for GLUMETZA

Drug Class

Biguanide

Paragraph IV (Patent) Challenges for GLUMETZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLUMETZA	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021748	1	2009-07-27

US Patents and Regulatory Information for GLUMETZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005		DISCN	Yes	No
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005		DISCN	Yes	No

Expired US Patents for GLUMETZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	8,323,692
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	6,340,475
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	6,635,280
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,635,280
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	7,780,987

International Patents for GLUMETZA

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

Country	Patent Number	Title	Estimated Expiration
Austria	302597
Australia	729529
Australia	8138698
Canada	2290624	FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE ARETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS)
Canada	2364845	PROLONGATION DE LA DUREE DE LIBERATION DE MEDICAMENT DANS L'ESTOMAC AU COURS DU MODE D'ALIMENTATION (EXTENDING THE DURATION OF DRUG RELEASE WITHIN THE STOMACH DURING THE FED MODE)

Supplementary Protection Certificates for GLUMETZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1412357	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408

GLUMETZA (metformin hydrochloride) market dynamics and financial trajectory: pricing pressure, share drivers, and exclusivity-to-generic risk

Last updated: June 24, 2026

Executive summary

• GLUMETZA (metformin HCl extended-release) is a branded ER metformin with a long-running U.S. presence; its financial trajectory is dominated by generic and authorized generic penetration, ER-metformin competition, and coverage-driven volume shifts rather than patent-led growth.
• The market has largely shifted to low-cost generic metformin ER and IR as formulary access expands and price competition intensifies.
• GLUMETZA’s revenue path in recent years is typically characterized by declining or plateauing branded sales (channel inventory normalization, contracting premium vs. generics, and payer step edits), with any remaining brand resilience tied to patient tolerability, prescriber familiarity, and managed-care contracting.
• For business planning, the key forward-looking risk is incremental generic erosion from additional competitors and contracting dynamics, with product-level upside constrained unless GLUMETZA regains payer share via discounting, contracting, or product differentiation.

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What is GLUMETZA (metformin HCl extended-release) and what market does it compete in?

Direct answer: GLUMETZA is metformin hydrochloride extended-release (ER) for type 2 diabetes, competing in a crowded class where generic metformin (ER and IR) sets the economic ceiling.

Therapeutic category and prescribing base

• Indication: Type 2 diabetes mellitus (adjunct to diet and exercise; also in combination regimens per labeling).
• Clinical positioning: metformin ER intended to improve tolerability and adherence relative to immediate-release schedules, and to support once-daily administration patterns.

Competitive set that matters commercially

GLUMETZA’s economic benchmark is not “all diabetes drugs,” but the metformin ER and metformin IR ecosystem, including:

• Generic metformin ER (multiple manufacturers, aggressive price competition).
• Generic metformin IR (often cheapest option; used when ER copays rise).
• Brand ER metformin competitors if any remain in specific segments (U.S. payer mix can still keep a small subset of branded ER in formulary, but premium pressure is persistent).

“Premium” economics and payer behavior

• Commercial viability for an ER metformin brand depends on:
  • Formulary tier placement (preferred vs. nonpreferred).
  • Copay design and benefit carve-in/out rules.
  • Step therapy (IR to ER switches, or metformin first-line requirements).
  • Utilization management and prior authorization triggers for higher-cost alternatives.

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How have metformin ER and GLUMETZA faced pricing pressure and generic substitution?

Direct answer: Pricing dynamics are dominated by generic substitution and payer preference for lower-cost metformin products, compressing GLUMETZA’s net price and share.

Generic substitution mechanics that drive revenue decline

• Class effect: when a drug is within a well-established generic backbone like metformin, payers can move utilization quickly.
• ER vs. IR trade: if ER copay rises, patients or prescribers revert to metformin IR; if ER is preferred, generics still undercut GLUMETZA’s price premium.
• Contracting and rebates: brands can retain share through rebates, but those rebates effectively convert into margin compression, shifting the financial trajectory from “growth” to “defend share.”

Net price compression versus unit growth

• Branded metformin ER outcomes often show:
  • unit volume deceleration as generics take share, and
  • net revenue rate erosion from discounting and payer leverage.

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What is the financial trajectory for GLUMETZA sales over time?

Direct answer: GLUMETZA’s financial trajectory in the U.S. is structurally constrained by sustained generic competition, typically producing declining branded sales and margin pressure rather than sustained growth.

What to expect in the income statement line items

Key financial movements for a branded metformin ER with entrenched generics:

• Gross-to-net spread increases over time as manufacturers respond to contracting.
• Operating margin compresses as spending shifts toward:
  • payer contracting,
  • trade spend,
  • patient support programs (PSPs) and adherence initiatives.

Forward-looking drivers for revenue

• Payer formulary stability and the “brand-to-generic mix” within ER metformin.
• Specialty pharmacy and wholesaler channel dynamics (inventory corrections can swing quarterly toplines).
• Switch rates after benefit redesign (annual formulary changes).

Note: A complete, quarter-by-quarter revenue table for GLUMETZA requires audited financial filings and/or pharmacy sales databases. Only qualitative market dynamics are provided here because no GLUMETZA-specific numeric sales data is included in the available material.

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What patents protect GLUMETZA and when do they expire?

Direct answer: GLUMETZA’s branded lifecycle is primarily governed by the history of metformin ER patenting and any remaining late-life protection such as formulations, methods of use, or manufacturing, but commercial outcomes are dominated by generic availability rather than a short remaining exclusivity window.

Patent estate categories that usually matter for ER metformin brands

• Formulation patents: ER matrix design, excipient systems, or release profiles.
• Method-of-use patents: dosing regimens or therapeutic use claims.
• Manufacturing process patents: pelletization, coating, or granulation schemes.

Exclusivity and generic entry linkage

• For GLUMETZA, the commercial question is less “is there patent protection” and more “what is still enforceable and listed for the product on FDA’s patent listing system,” because generic entry is determined by:
  • Orange Book listed patents,
  • alleged infringement scope,
  • litigation outcomes and any settlements.

This response does not list specific GLUMETZA patent numbers or expiration dates because no Orange Book record or patent list is provided in the input material.

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What is the Orange Book status of GLUMETZA?

Direct answer: GLUMETZA’s Orange Book status determines whether ANDA filers can route via Paragraph IV and whether any active listed patents remain for enforcement.

How to interpret Orange Book listings for a branded ER metformin

• Patent categories frequently include:
  • Drug substance,
  • Drug product,
  • Method-of-use,
  • and formulation/manufacturing related claims.
• The practical value for business and litigation planning is:
  • whether any patents are still listed as “unexpired,” and
  • whether there are active Hatch-Waxman triggers that block launch.

No Orange Book listing details are included in the available material, so this section is limited to interpretive guidance.

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Have Paragraph IV challenges or ANDA litigation shaped GLUMETZA market share?

Direct answer: For legacy branded metformin products, ANDA litigation is often a gating event for specific generic entries, but once multiple generics exist, the dominant factor becomes ongoing price competition rather than a single milestone.

Litigation’s typical commercial impact pattern

• Short-term market share shifts occur when:
  • a new generic launches after a settlement or court ruling,
  • an “at-risk” entrant gains quicker benefit access.
• Medium-term impact:
  • branded sales tend to fall after additional generic entrants establish multiple sourcing and stronger contracting leverage.

This response does not name specific lawsuits, court dates, or settlement agreements because no case records are provided.

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Which generics and authorized alternatives compete most directly with GLUMETZA?

Direct answer: The most direct competitors are generic metformin ER products and, depending on payer design, generic metformin IR used as a low-cost substitute.

Competitive share drivers inside “metformin ER”

• Number of generic SKUs available in the same dose strengths and package sizes.
• PBM formulary placement and copay differentials.
• Wholesale channel distribution coverage that reduces stock-outs and improves pharmacy switching.

Authorized generics and contracting leverage

• Where an authorized generic is available, it often:
  • increases payer switching,
  • compresses branded net price through price anchoring.

A ranked competitor list by manufacturer and product strength requires Orange Book and/or pharmacy claims or sales data not provided here.

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How does GLUMETZA compare with other metformin ER products in market access and economics?

Direct answer: Competitive advantage, if any, is typically limited to tolerability and payer contracting. In most markets, generics compress the economic premium.

Key differentiators that can influence prescribing

• Dosing convenience and titration approach.
• Gastrointestinal tolerability profile (patient-specific).
• Prescriber confidence and historical persistence.

Key differentiators that shape payer policy

• Prior authorization criteria and step therapy programs.
• Copay and deductible treatment.
• Contract rebate structure and whether the product is “preferred” on specific PBMs.

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How do FDA approval pathways and labeling updates affect GLUMETZA commercialization?

Direct answer: For metformin ER brands, FDA pathways affect entry timing mainly through ANDA approvals and bioequivalence; labeling updates rarely create brand-new market expansion in a mature class.

Practical FDA-driven outcomes

• Any changes to:
  • dosing instructions,
  • contraindications,
  • warnings,
  • or patient counseling materials can influence:
  • pharmacist substitution behavior,
  • adherence support,
  • and payer coverage justifications.

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What manufacturing and supply-chain issues could impact GLUMETZA revenue?

Direct answer: Supply stability is important for ER metformin brands because formulary switching can be immediate during shortages; however, most branded outcomes are still driven by price and contracting once supply is restored.

Typical risk channels

• Facility compliance and batch-release delays that can restrict distribution.
• Partner or subcontractor constraints for film/coating and modified-release manufacturing.

No GLUMETZA-specific supply disruptions are included in the input material.

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Revenue exposure scenario: what generic launch risks remain for GLUMETZA?

Direct answer: The primary generic risk is incremental erosion from additional entrants, package-size competition, and stronger PBM contracting that makes switching cheaper for patients and pharmacies.

Scenario framework (qualitative)

• Base case: continued branded volume decline or stabilization at low levels; margin pressured by contracting.
• Downside: additional generic entrants or escalated preferred formulary placement for generics drives step-edit switching.
• Upside: localized payer wins or formulary reinstatement through rebate redesign; limited if class-wide generic penetration is high.

Scenario quantification requires GLUMETZA historical sales and competitor share data not provided.

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Key takeaways

• GLUMETZA operates in a mature metformin ER market where generic and class substitution dominate financial performance.
• Market dynamics are driven by payer formularies, rebate/copy dynamics, and step therapy, not by a near-term patent-led growth arc.
• The most material business risk remains incremental generic and package-level price erosion, which typically translates into branded net price pressure and share loss.
• Revenue trajectory is best modeled as defend-share economics rather than expansion, with outcomes sensitive to PBM contracting and benefit design cycles.

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FAQs

1. Why do payers prefer generic metformin ER over branded GLUMETZA?
   Because metformin ER is a mature, therapeutically interchangeable class with robust generic supply; PBMs can reduce costs through formulary tier placement and copay design.

2. Does metformin ER get substituted to metformin IR when GLUMETZA copays rise?
   Often, yes, because IR metformin is usually the lowest-cost metformin option; substitution behavior increases when ER copays are not protected.

3. How do formulary changes typically affect GLUMETZA quarterly sales?
   They can cause discrete shifts in volume in the quarter after benefit redesign, especially around PBM open enrollment cycles and annual formulary updates.

4. What factors determine whether a new metformin ER generic launch accelerates branded decline?
   PBM preferred status, rebate competitiveness, package strength coverage, and pharmacy switching friction (availability, stock, and dispensing policies).

5. Can GLUMETZA maintain profitability despite generic competition?
   It can sometimes through contracting and margin management, but sustained profitability generally requires active rebate strategy and preferred access, which can still limit long-term upside.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book).
2. U.S. Food and Drug Administration. ANDA Bioequivalence guidance and regulatory pathway materials. (accessed via FDA guidance repository).

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