BRYNOVIN Drug Patent Profile

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

Brynovin is a drug marketed by Azurity and is included in one NDA. There are two patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in BRYNOVIN is sitagliptin hydrochloride. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sitagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Brynovin

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BRYNOVIN

International Patents:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3
What excipients (inactive ingredients) are in BRYNOVIN?	BRYNOVIN excipients list
DailyMed Link:	BRYNOVIN at DailyMed

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

NDA:

219122

Dosage:

SOLUTION;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 BRYNOVIN

BRYNOVIN 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
Azurity	BRYNOVIN	sitagliptin hydrochloride	SOLUTION;ORAL	219122-001	Jan 16, 2025		RX	Yes	Yes			Y
Azurity	BRYNOVIN	sitagliptin hydrochloride	SOLUTION;ORAL	219122-001	Jan 16, 2025		RX	Yes	Yes			Y

International Patents for BRYNOVIN

When does loss-of-exclusivity occur for BRYNOVIN?

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

European Patent Office

Poland

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 BRYNOVIN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3811930
European Patent Office	4048230
Spain	2961549
Poland	4048230
World Intellectual Property Organization (WIPO)	2021078964

Supplementary Protection Certificates for BRYNOVIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	PA2007006	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1412357	SPC/GB07/046	United Kingdom		PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323
1412357	122007000056	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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	300287	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070323
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

Last updated: June 21, 2026

BRYNOVIN market dynamics and financial trajectory: sales drivers, pricing pressure, exclusivity risk, and forecast by segment

BRYNOVIN’s market trajectory is determined by (1) the timing of regulatory approvals and label breadth, (2) competitive displacement from therapeutic alternatives, (3) payer access and net price erosion, and (4) exclusivity and patent-risk windows that govern generic and biosimilar entry timing. Without verifiable FDA product identity, launch date, dosage form, sponsor/manufacturer, and approved indication set, the financial trajectory cannot be mapped to Orange Book exclusivity, Paragraph IV exposure, or realistic payer-driven net sales curves for BRYNOVIN.

What is BRYNOVIN’s FDA status and launch timeline that drives revenue?

Featured snippet: BRYNOVIN’s financial trajectory depends on when it first entered the FDA market (approval date, marketing start, and label scope). Those are not provided here, so sales timing cannot be anchored to an FDA milestone curve.

Which FDA pathway and label scope determine uptake curves?

Key determinants for early adoption and revenue ramp are:

• Regulatory pathway (NDA vs 505(b)(2); standard vs accelerated review)
• First approved indication(s) and later label expansions
• Trial endpoint alignment to payer restrictions (step edits, prior auth criteria)
• REMS requirements (if any) that can constrain prescriber behavior

What is the market size implied by BRYNOVIN’s approved indication(s)?

Revenue potential scales with:

• Eligible patient prevalence and incidence (diagnosis-driven vs biomarker-driven)
• Line-of-therapy positioning (first-line vs later lines)
• Comorbidity profile affecting persistence and dose intensity

How do payer access rules and net price erosion shape BRYNOVIN profitability?

Featured snippet: Net sales trajectory is driven by payer contracting outcomes, formulary tier placement, and utilization management. These variables are not specified for BRYNOVIN.

Formulary placement and utilization management

Typical mid-market effects come from:

• Placement on preferred tiers vs non-preferred tiers
• Prior authorization requirements and step edits
• Quantity limits and refill policies

Net price vs list price dynamics

Net price erosion usually accelerates after:

• Therapeutic class competition intensifies
• Biosimilar or generic alternatives emerge
• Payers expand coverage with lower-cost substitutes

What competitors displace BRYNOVIN and how does that impact market share?

Featured snippet: BRYNOVIN’s share is a function of relative efficacy, safety, convenience, and total cost versus alternatives in its therapeutic class. Competitor list and class positioning are not provided.

Competitive landscape drivers

Displacement risk typically increases with:

• Lower out-of-pocket costs for competitors
• Better formulary access for competitors
• Switching due to real-world tolerability or administration advantages
• Expanded indications that broaden addressable patient pools for rivals

How does BRYNOVIN compare on dosing frequency and administration burden?

Administration convenience affects:

• Clinic vs home administration patterns
• Persistence (treatment continuation)
• Pharmacy benefit management channel assignment

When do BRYNOVIN exclusivity barriers expire and how does that change the sales curve?

Featured snippet: Exclusivity expiration and patent expiry govern the steepness of post-peak revenue decline. Patent and exclusivity timelines for BRYNOVIN are not provided here.

What Orange Book protections likely control generic entry?

Generic entry risk typically ties to:

• Active ingredient composition-of-matter patents
• Method-of-use patents
• Formulation and dosage-form patents
• Risk period for 505(b)(2) carve-outs

How to map revenue risk to patent/payer timing

In practice, revenue decline starts before expiry due to:

• Patent litigation timelines
• Early market preparation by generics and authorized generics
• Payer anticipation and contract renegotiations

What patents protect BRYNOVIN and how strong is the estate?

Featured snippet: A strong estate shows multiple, staggered blocking patents across composition, formulation, and method-of-use. BRYNOVIN’s patent portfolio details are not included.

Portfolio structure that usually matters for blocking

The estate strength framework usually evaluates:

• Number of Orange Book-listed patents per NDA/BLA
• Staggering of expiry dates
• Litigation history and the presence of terminal disclaimers
• Breadth of claim scope relative to generic design-around pathways

Geographic coverage that impacts regional revenue

For multi-market financial planning, coverage must be assessed for:

• U.S. (Orange Book, 35 USC 271)
• Europe (SPC and national patents)
• Key emerging markets (local patentability and enforcement)

What Paragraph IV challenges exist for BRYNOVIN and when could generic launch occur?

Featured snippet: Paragraph IV filings create specific launch exposure windows tied to the 180-day exclusivity and litigation outcomes. No BRYNOVIN Paragraph IV data is provided here.

How Paragraph IV timing compresses BRYNOVIN revenue

Loss of exclusivity can drive:

• Rapid utilization shift if payer contracts favor generics
• Wholesale channel inventory adjustments
• Price convergence within the class

Authorized generics and settlement-driven timing

Settlement agreements can:

• Delay launch to a set “carve-out” date
• Provide revenue protection via agreed entry dates
• Trigger volume-based payments or supply arrangements (where disclosed)

What is the biosimilar risk profile for BRYNOVIN if it is a biologic?

Featured snippet: Biosimilar risk depends on reference product status, BLA/biologic exclusivity, and biosimilar-specific patent estates. BRYNOVIN’s product type (biologic vs small molecule) is not specified.

Which exclusivities and patent types matter for biosimilars

For biologics, the critical protections include:

• 12 years reference product exclusivity (where applicable)
• 4 to 5 years depending on first licensure and exclusivity drivers
• Intervening U.S. and foreign patents that cover:
  • Structure and purity
  • Manufacturing process
  • Formulation and device
  • Methods of use

What formulation and method-of-use patents can extend BRYNOVIN revenue beyond core expiry?

Featured snippet: Late-life extensions commonly come from formulation, dosing regimens, and method-of-use claims. BRYNOVIN’s formulation and method-of-use patent list is not provided.

Extended-release, stability, and delivery patents

Formulation patents can block:

• Equivalent release profiles
• Bioequivalence design-around formulations
• Stability-driven shelf-life competitors

Dosing regimen and population-specific use patents

Method-of-use patents can:

• Restrict generic label entry to narrower populations
• Delay switching if prescribers require guideline-concordant regimen language

Which lawsuits and settlements affect BRYNOVIN’s financial trajectory?

Featured snippet: Patent litigation outcomes determine effective exclusivity duration through settlement dates and court rulings. No litigation docket information for BRYNOVIN is provided.

Common litigation timelines that move revenue

Revenue inflection usually aligns with:

• Complaint and counterclaim filings
• Claim construction outcomes
• Final infringement/non-infringement decisions
• Settlement effective dates

What to monitor for earnings and guidance

Companies typically track:

• Status of key asserted patents
• Schedule for dispositive motions
• Settlement terms that define entry dates

What does BRYNOVIN revenue look like by channel and geography?

Featured snippet: Channel mix and geography drive margin profile through rebates, distribution economics, and payer contracting differences. BRYNOVIN’s segment reporting and market presence details are not provided here.

U.S. vs ex-U.S. revenue patterns

Ex-U.S. typically shows:

• Different patent enforcement strength
• Pricing controls and reimbursement variability
• Faster or slower generic penetration depending on local systems

Hospital, specialty pharmacy, and retail split

Channel affects:

• Reimbursement rates
• Operational costs (inventory, logistics)
• Discount and rebate structures

What financial trajectory is plausible for BRYNOVIN: ramp, peak, and decline?

Featured snippet: A credible financial trajectory requires hard inputs: approval date, indication expansion timeline, net pricing, and exclusivity/patent expiry map. None are provided.

Revenue ramp model inputs

To model ramp and peak, companies typically use:

• Uptake rate from prescriber adoption curves
• Persistence or discontinuation rates
• Dose escalation and adherence
• Coverage penetration through payers

Decline model inputs

To forecast decline, companies rely on:

• Patent expiry and litigation outcome calendar
• Expected generic/biosimilar launch sequencing
• Net price trajectory post-entry (contract-driven)

BRYNOVIN vs key alternatives: what drives differential pricing and adoption?

Featured snippet: Adoption and pricing are driven by comparative outcomes, safety/tolerability, and total cost of therapy. The relevant alternatives and BRYNOVIN’s comparative profile are not stated.

Pricing and contracting levers

Key levers include:

• Value-based contracting (outcomes-based reimbursement)
• Preferred formulary tier strategy
• Manufacturer rebates tied to net revenue protection

Clinical and real-world factors

Real-world factors include:

• Adverse event rates affecting discontinuation
• Administration burden affecting adherence and persistence
• Switching dynamics among prescribers

Key Takeaways

• BRYNOVIN’s market dynamics and financial trajectory are governed by FDA timeline, payer access, competitive displacement, and exclusivity-to-entry mechanics.
• The information required to produce an actionable sales and patent-risk timeline for BRYNOVIN is not present here, so no defensible revenue forecast, patent expiry calendar, or generic/biosimilar entry scenario can be stated.
• Any investment, licensing, or litigation planning tied to BRYNOVIN requires mapping the product to its FDA listing, Orange Book protections, and disclosed market access outcomes.

FAQs

1. How do payer step edits and prior authorization policies typically affect net sales for new specialty drugs like BRYNOVIN?
2. What is the difference between list price and net price in U.S. pharmaceutical contracting, and how does it influence BRYNOVIN margin trajectory?
3. How do Paragraph IV filings translate into expected generic launch timelines and sales erosion for branded products?
4. What patent estate elements most often extend exclusivity via formulation or method-of-use protections?
5. How does real-world persistence and discontinuation change revenue forecasting for chronic therapies such as BRYNOVIN?