DEGARELIX ACETATE - Generic Drug Details

What are the generic drug sources for degarelix acetate and what is the scope of freedom to operate?

Degarelix acetate is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Degarelix acetate has one hundred and eight patent family members in twenty-four countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for DEGARELIX ACETATE

International Patents:	108
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	36
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEGARELIX ACETATE
DailyMed Link:	DEGARELIX ACETATE at DailyMed

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

Dosage:

POWDER;SUBCUTANEOUS

^*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 DEGARELIX ACETATE

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

Sponsor	Phase
Fudan University	Phase 2
Alliance for Clinical Trials in Oncology	Phase 3
Myovant Sciences GmbH	Phase 1

See all DEGARELIX ACETATE clinical trials

Generic filers with tentative approvals for DEGARELIX ACETATE

Applicant	Application No.	Strength	Dosage Form
		80MG	NJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for DEGARELIX ACETATE

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for DEGARELIX ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRMAGON	Powder for Injection	degarelix acetate	80 mg/vial and 120 mg/vial	022201	1	2019-12-20

US Patents and Regulatory Information for DEGARELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes

Expired US Patents for DEGARELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008

International Patents for DEGARELIX ACETATE

Country	Patent Number	Title	Estimated Expiration
Australia	2009213748
Australia	2009213751
Brazil	PI0908127
Brazil	PI0908129
Canada	2714444
Canada	2714445

Supplementary Protection Certificates for DEGARELIX ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	122009000033	Germany		PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217
1003774	PA2009005	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	SPC/GB09/028	United Kingdom		PRODUCT NAME: DEGARELIX OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT SUCH AS THE ACETATE; REGISTERED: UK EU/1/08/504/001 20090217; UK EU/1/08/504/002 20090217
1003774	09C0028	France		PRODUCT NAME: DEGARELIX, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/504/001 DU 20090217; REGISTRATION NO/DATE AT EEC: EU/1/08/504/001 DU 20090217
1003774	PA2009005,C1003774	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	91585	Luxembourg		PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217

Degarelix Acetate (Firmagon) Market Dynamics and Financial Trajectory (US and EU)

Last updated: June 22, 2026

Degarelix acetate (marketed as Firmagon) is a GnRH receptor antagonist used for advanced hormone-sensitive and metastatic prostate cancer. The commercial trajectory has been shaped by (1) class-level competition from GnRH agonists and (2) displacement pressure from competing branded and long-acting formulations, with later entry of generics in some geographies. In the US, Firmagon’s sales have been pressured by competitive launches in androgen deprivation therapy (ADT) and by formulary migration toward longer-interval depot products. In multiple markets, the patent and exclusivity profile has supported eventual generic entry, contributing to margin erosion and revenue decline over time.

How has Firmagon (degarelix acetate) performed financially since launch?

Firmagon’s financial trajectory is consistent with a branded ADT asset entering a mature segment: peak brand revenues followed by steady erosion as (a) longer-interval depot GnRH agonists and (b) other GnRH antagonist/ADT competitors captured share. The sales curve typically declines first through formulary shifts and later through generic competition where filings succeed.

US commercial trajectory: what drives revenue decline

Key market drivers for US degarelix acetate sales decline:

• Treatment pattern shift to longer dosing intervals: Providers and payers favor products with less injection frequency, which reduces patient burden and clinic administration time.
• Competitive ADT landscape: Long-acting depot products have moved to dominant placement on formularies, pressuring Firmagon’s share.
• Generic entry risk and utilization changes: Once generic availability appears, payer incentives and acquisition behavior accelerate share loss and price compression.

EU commercial trajectory: what drives price and volume pressure

EU dynamics also trend toward branded-to-generic conversion:

• National formularies and tendering: Public procurement and contracting structures can accelerate price reductions after generic entry.
• Switching after LOE events: When patent/exclusivity barriers fall, prescribers often switch quickly within classes.

What market dynamics determine degarelix acetate share in ADT?

Degarelix acetate competes in ADT, with practical differentiation driven by dosing design, onset dynamics, and clinical positioning rather than a fundamentally different mechanism.

Clinical and operational factors that shape uptake

• Injection logistics: Degarelix is administered by subcutaneous injection, with an initial dose followed by monthly dosing. Clinic workflows and patient preference influence utilization.
• Payer behavior: ADT reimbursement frequently uses step therapy, prior authorization, and formulary tiering that can disadvantage shorter-interval or higher-cost options once comparable alternatives are available.
• Institutional prescribing patterns: Large oncology practices tend to standardize therapy by protocol. Protocol standardization can lock in competitors for years until a strong economic or guideline shift occurs.

When does Firmagon lose exclusivity, and what generic entry risks exist?

Degarelix acetate’s exclusivity timeline determines the shape of revenue decline and the pace of generic displacement. The critical inflection points for branded ADT products are the expiration of the last core composition and method patents plus any supplementary exclusivity (jurisdiction specific), which then governs when ANDA and biosimilar-style equivalents (if applicable) can enter.

Orange Book status and Paragraph IV risk profile

In the US, the generic entry risk is typically realized through ANDA filings referencing Firmagon and challenging one or more listed patents (Paragraph IV). When the last listed patent expires and any relevant exclusivity ends, authorized generics and subsequent ANDAs can launch.

How patent expiration timing affects revenue curve

A common pattern for assets like degarelix acetate:

• Pre-expiry: Revenue decline is driven by competitive switching and tender pressure even before generic launch.
• Launch window: Accelerated revenue drop after generic entry due to price competition and payer switching.
• Post-launch: Further erosion as multiple generics and rebates compress net price.

How many patents cover degarelix acetate, and how strong is the patent estate?

Firmagon’s patent estate in core jurisdictions typically spans:

• Composition of matter (degarelix acetate and related structures)
• Formulations (stability, salts, concentration ranges, manufacturing parameters)
• Method-of-use (prostate cancer indications and dosing regimens)

For revenue protection, the strength is measured by whether late-expiring formulation and method-of-use patents remain enforceable at the time composition claims expire. Patent estates that fragment across jurisdictions often allow partial barrier removal in one market even if others remain protected.

What formulations are protected for degarelix acetate?

Degarelix’s marketed product form is an injectable depot-style formulation for subcutaneous administration. Patent coverage in this class usually includes:

• Stabilized formulations (buffer systems, pH, excipients that maintain solubility and particle behavior)
• Dose and concentration specifications that support consistent release and tolerability
• Manufacturing methods tied to particle formation and shelf-life

Why formulation patents matter commercially

Formulation patents can delay generic approvals even after active ingredient patents expire if generics must demonstrate design-around capability or submit narrower certifications.

What patent litigation affects Firmagon (degarelix acetate) and generics?

For mature injectable oncology brands, the most commercially relevant litigation typically involves:

• Patent infringement actions tied to ANDA certifications
• Settlement agreements that set launch dates or restrict design-around attempts
• Court outcomes that determine which patents remain enforceable and which are invalidated

Litigation impacts the financial trajectory by shifting the expected generic launch timing and by influencing payer confidence in near-term availability.

What settlements and licensing deals can change the financial trajectory?

In the US, branded-to-generic settlements often convert uncertainty into dated expectations. The economic impact is typically:

• Delayed generic entry increases branded revenues versus a full court-loss outcome.
• Earlier-than-expected settlements can cap late-stage revenue if a generic launches sooner with a broadened label.

Settlement structure can also affect whether generics launch at full strength, with shared exclusivity-like constraints in certain periods, or through authorized generic arrangements.

What is the regulatory and FDA status of degarelix acetate?

Degarelix acetate is an approved injectable product for prostate cancer management under the FDA. Competitive landscape and financial results are shaped by:

• Label scope and any changes to indications over time
• Postmarketing commitments and manufacturing authorizations
• Switching incentives created by alternative approved ADT products with longer intervals

Regulatory pathway implications for competitors

• Generic pathway: ANDAs for formulation and bioequivalence submissions can launch upon patent and exclusivity clearance.
• Competitive branded products: New depot formulations do not require patent expiry for approval but can dominate access through clinical guideline adoption and payer placement.

How does degarelix acetate compare with competing ADT drugs in market dynamics?

Degarelix’s market performance is best understood relative to alternatives. The key comparison dimensions are:

• Dosing interval and administration burden
• Payer and guideline preference
• Net pricing and rebate structures
• Competitive pipeline timing

Comparison framework: what matters to payers

• Monthly dosing vs longer-interval depots: Longer interval dosing often improves patient and clinic throughput.
• Net cost after rebates: Brand-to-brand competition often determines net price stability.
• Formulary tier placement: Tier position can drive volume more than clinical differentiation.

Which companies are the main competitors to Firmagon (degarelix acetate)?

Competitors typically include:

• Branded and generic ADT drugs across GnRH agonists and other ADT agents
• Depot formulations that compete for the same patient lines
• Regional generic suppliers that become relevant once patents allow ANDA launches

The competitive impact depends on whether alternatives are positioned as preferred or non-preferred and on whether they are widely stocked by distributors.

What generic entry scenarios exist for degarelix acetate?

Commercial scenarios for generic entry often follow one of three patterns:

Scenario 1: Single entrant with limited supply

• Slower share loss due to supply constraints
• Brand revenues decline but at a moderated rate

Scenario 2: Multiple entrants drive net price compression

• Rapid revenue drop driven by payer switching and rebate pressure
• Brand profitability compresses and channel inventory clears faster

Scenario 3: Authorized generic or early settlement

• Brand revenue declines earlier in the exclusivity window than investors expect
• Upside for the brand is limited to the remaining unchallenged patents

Revenue exposure: how much profit is typically at risk in LOE-to-generic transition?

In oncology injectables with mature competition, the profit exposure concentrates in:

• Net sales erosion due to price compression
• Higher contracting pressure after generics appear
• Margin volatility from rebate changes and inventory adjustments

The magnitude depends on how quickly formularies switch and how many entrants appear. Multiple entrant environments generally reduce the post-LOE revenue more sharply.

Key Takeaways

• Degarelix acetate’s financial trajectory reflects a typical branded ADT pattern: peak sales followed by steady decline driven by longer-interval competitive products and later generic displacement in markets where patent and exclusivity barriers fall.
• The revenue curve shape is determined less by mechanism than by payer behavior, dosing logistics, and the timing of patent and exclusivity expiry followed by ANDA launch outcomes.
• Litigation, settlement, and patent fragmentation across jurisdictions are the main levers that shift the timing of generic competition and therefore the slope of branded revenue decline.

FAQs

1. Do degarelix acetate patents cover only the active ingredient, or are formulation and dosing patents also key?
2. How do Paragraph IV ANDA challenges typically affect Firmagon’s launch timing for generic competitors?
3. What formulary and tender mechanisms in Europe accelerate switching after degarelix acetate exclusivity ends?
4. Which ADT competitors most influence degarelix acetate share based on dosing interval and payer placement?
5. What are the common settlement structures in ADT generics that change expected branded revenue before patent expiry?

References

(No sources were provided in the prompt, so no citations can be listed without introducing uncited claims.)