TRELSTAR Drug Patent Profile

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

Trelstar is a drug marketed by Verity and is included in three NDAs. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trelstar

Trelstar was eligible for patent challenges on June 15, 2004.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRELSTAR

International Patents:	47
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	1,038
Drug Prices:	Drug price information for TRELSTAR
What excipients (inactive ingredients) are in TRELSTAR?	TRELSTAR excipients list
DailyMed Link:	TRELSTAR at DailyMed

See drug prices for TRELSTAR

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

Constraining patent/regulatory exclusivity:

10,166,181

NDA:

022437

Dosage:

INJECTABLE;INTRAMUSCULAR

^*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 TRELSTAR

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	PHASE2
Zenith Epigenetics	PHASE2

See all TRELSTAR clinical trials

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

This potential generic entry date is based on patent 10,166,181.

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
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Expired US Patents for TRELSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,225,205
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,134,122
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,225,205
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,192,741
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,776,885

International Patents for TRELSTAR

When does loss-of-exclusivity occur for TRELSTAR?

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

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 TRELSTAR around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	397197
Austria	397198
Austria	A154590
Austria	A223591
Australia	5910390

Last updated: July 24, 2026

Trelstar (triptorelin) market dynamics and financial trajectory: pricing, sales trend, launch competition, and exclusivity/patent watchpoints

Trelstar (triptorelin) sales have tracked the cycle of androgen deprivation therapy demand in prostate cancer and the stability of depot formulation supply, with revenue sensitivity concentrated in the US due to payer coverage and generic/biosimilar-free competitive structure for the long-acting injectables. The product’s financial trajectory is also shaped by lifecycle transitions across Trelstar formulations (notably the 3.75 mg monthly depot and 11.25 mg every-3-month depot), wholesaler purchasing patterns ahead of label and contracting changes, and the pace of any Paragraph IV or authorized generics affecting long-acting GnRH agonists.

What is Trelstar (triptorelin) and how does it make money for manufacturers?

Trelstar is a gonadotropin-releasing hormone (GnRH) agonist indicated in prostate cancer for androgen deprivation. It is marketed as long-acting depot injections that sustain systemic triptorelin exposure and reduce injection frequency versus shorter-acting GnRH agonists. Revenue is driven by:

• Patient incidence and persistence on androgen deprivation therapy
• Treatment line mix (newly treated versus progressing disease states that require continued suppression)
• Formulation mix (monthly vs every-3-month depots)
• Net price and reimbursement pressure in US outpatient and hospital-administered settings
• Contract pharmacy and major group purchasing organization dynamics

Which formulations matter most for revenue?

Depot formulations are the core economic units because they govern administration frequency, patient adherence, and payer reimbursement benchmarks.

• Trelstar 3.75 mg: typically supports monthly treatment economics
• Trelstar 11.25 mg: typically supports every-3-month economics and can improve unit economics per administration through reduced visits and administration overhead

Where does revenue sit in the supply chain?

For injectable oncology endocrine therapy, manufacturer revenue depends on:

• Wholesale acquisition cost and distributor markups
• Provider reimbursement and patient cost-sharing
• Buy-and-batch behavior around contracting windows and inventory resets

How has Trelstar’s US market evolved and what are the key demand drivers?

Demand is mostly not “brand-switchable” in the way oral small molecules are, because GnRH agonists require administration and depot handling. Switches occur via:

• Payer preference for specific long-acting injectables
• Clinical practice guidelines and physician habit formation
• Medical benefit purchasing and formulary placement
• Supply reliability and depot availability

Prostate cancer incidence and ADT adoption

The economic engine is the prevalence of prostate cancer requiring androgen deprivation. ADT volume is shaped by:

• Diagnosed incidence and staging migration
• Use of combination regimens (ADT with androgen receptor pathway inhibitors)
• Duration of therapy in metastatic versus localized settings
• Institutional protocols for sequencing and re-staging

What drives short-term fluctuations in sales?

• Quarterly purchasing variability by wholesalers and large distributors
• Payer administrative changes affecting prior authorization or preferred product status
• Inventory correction cycles after supply or contracting events
• Seasonal clinic scheduling effects on injection calendars

What competitive landscape pressures Trelstar and how does it compare with other GnRH agonists?

Trelstar competes in a broader class of androgen deprivation therapies including:

• Other long-acting GnRH agonists (monthly and every-3-month depots)
• GnRH antagonists where adopted (in certain settings due to different adverse effect profile considerations)
• Surgical castration and other endocrine options, though these are not the direct economic competitor for depot injection procurement

How does depot frequency affect competitive positioning?

Every-3-month depots often compete on reduced administration burden and improved convenience, which can translate into payer and provider preference when pricing is competitive.

Where do switching costs appear?

• Administration protocols and pharmacy workflows
• Physician familiarity with product handling
• Patient stabilization on a given depot schedule

When does Trelstar lose exclusivity in the US and what patent events matter?

A drug’s practical sales cliff depends on the interplay of:

• Orange Book listed patents (drug substance, drug product, and method patents)
• Non-patent exclusivity (if any) such as pediatric exclusivity
• Patent term adjustments and patent term extensions
• Enforcement outcomes that delay generic entry

No complete, source-citable exclusivity and Orange Book event timeline can be produced here without the specific Orange Book patent numbers and expiration dates.

What patents protect Trelstar and how many are listed for the key formulations?

Trelstar’s patent estate typically spans:

• Depot formulation composition and release characteristics
• Drug product manufacturing controls and process patents
• Method-of-use patents for indicated regimens

No complete, source-citable answer can be produced without the Orange Book listings (patent numbers, expiration dates, and application references) for each marketed strength and dosing regimen.

What generic entry risks exist for Trelstar (Paragraph IV, authorized generics, and litigation)?

For products with meaningful patent coverage in the Orange Book, the principal entry risk channels are:

• ANDA Paragraph IV certifications challenging one or more listed patents
• Settlement agreements that cap generic launch dates
• Design-around attempts that avoid formulation or method claims
• Authorized generic launches that dilute brand volume but preserve some economics for the license holder

No source-citable Paragraph IV or settlement record for Trelstar can be stated here without the case docket and Orange Book patent mapping.

What is the Orange Book status of Trelstar (and which patents are active)?

Orange Book status is the gating data for forecasting generic vulnerability:

• Listing type (drug substance, drug product, method of use)
• Listed patent expiration dates
• Remaining patent life by formulation strength
• Suitability for ANDA certifications

No source-citable Orange Book status can be produced here without the drug’s Orange Book patent list and current status lines.

How strong is the patent estate for Trelstar versus peer GnRH agonists?

Patent strength is assessed by:

• Number of active Orange Book patents per formulation
• Whether dominant patents are drug product or method claims
• Litigation history and validity outcomes
• Breadth of method-of-use claims that are hard to design around

No source-citable comparative strength analysis can be produced here without an extract of Trelstar’s active patent list and expiration profile and those of relevant comparator drugs.

What manufacturing or IP barriers could restrict generic competition?

Depot injectables face practical barriers that can complement legal barriers:

• Scale-up and sterile manufacturing controls
• Microenvironment and release kinetics replication
• Delivery system validation for long-acting depots
• Device or kit integration constraints, if any in the specific supply chain

A barrier-specific view for Trelstar requires dossier-level and patent-level mapping that is not available in the data provided here.

FDA status: what is the approval and pathway context for Trelstar?

For established depot injectable GnRH agonists, FDA approval context matters for:

• Exclusivity stacking
• Listing longevity and labeling changes
• Safety updates affecting persistence and substitution

No source-citable FDA milestones (approval dates, labeling revisions, supplements) can be produced here without the product-specific FDA approvals and labeling history.

Financial trajectory: how have Trelstar revenues moved, and what explains the trend?

A defensible financial trajectory requires:

• Manufacturer segment sales attribution to Trelstar
• Net sales changes versus unit volume
• Gross-to-net drivers (discounts, rebates, chargebacks)
• Geographic mix shifts

No source-citable revenue series can be produced here because no company financial statements, segment reporting, or sales datasets were provided or cited.

What are the key revenue sensitivities for Trelstar going forward?

Even without a numeric sales table, the main levers that move Trelstar profitability in practice are:

• Formulation mix: every-3-month depot penetration affects per-patient visit economics
• Net price: payer contracting and oncology endocrine reimbursement benchmarks
• Supply stability: depot manufacturing yields, sterile facility uptime, and logistics
• Switching and competitive entries: any challenger long-acting depot with favorable pricing
• Regimen adoption: duration and persistence on ADT influences time-on-therapy revenue

Key Takeaways

• Trelstar’s market is driven by ADT demand and persistence in prostate cancer, with revenue concentration shaped by depot formulation mix and payer contracting.
• Competitive pressure typically comes from within-class androgen deprivation injectables and, selectively, from GnRH antagonists depending on practice patterns.
• Forecasting a sales cliff requires Orange Book patent-by-patent expiration mapping and any Paragraph IV or settlement records; that data is not available in the provided information.
• Numeric financial trajectory and revenue drivers cannot be stated with hard citations without company sales disclosure or a sales dataset.

FAQs

1. How do depot dosing changes (3.75 mg vs 11.25 mg) affect Trelstar reimbursement and persistence?
2. What payer contracting patterns most influence Trelstar net price in the US?
3. Do GnRH antagonists materially reduce Trelstar share in metastatic prostate cancer, and in which lines of therapy?
4. What Orange Book patent types (drug product vs method of use) typically create the hardest-to-design-around barriers for long-acting triptorelin injectables?
5. How do wholesale buying cycles and inventory corrections typically distort quarterly Trelstar sales trends?

References

1. None.

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