AGRYLIN Drug Patent Profile

Which patents cover Agrylin, and what generic alternatives are available?

Agrylin is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in AGRYLIN is anagrelide hydrochloride. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Agrylin

A generic version of AGRYLIN was approved as anagrelide hydrochloride by CIPLA on April 18^th, 2005.

Summary for AGRYLIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	3
Patent Applications:	36
Drug Prices:	Drug price information for AGRYLIN
What excipients (inactive ingredients) are in AGRYLIN?	AGRYLIN excipients list
DailyMed Link:	AGRYLIN at DailyMed

See drug prices for AGRYLIN

Recent Clinical Trials for AGRYLIN

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

Sponsor	Phase
Shire	Phase 3
Mylan Pharmaceuticals	Phase 1

See all AGRYLIN clinical trials

Pharmacology for AGRYLIN

Drug Class	Platelet-reducing Agent
Mechanism of Action	Phosphodiesterase 3 Inhibitors
Physiological Effect	Decreased Platelet Production

US Patents and Regulatory Information for AGRYLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	AGRYLIN	anagrelide hydrochloride	CAPSULE;ORAL	020333-001	Mar 14, 1997	AB	RX	No	No
Takeda Pharms Usa	AGRYLIN	anagrelide hydrochloride	CAPSULE;ORAL	020333-002	Mar 14, 1997		DISCN	Yes	No

Agrylin Market Dynamics, Revenue Trajectory, Patent Status, and Generic Competition

Last updated: September 25, 2026

Agrylin is the U.S. brand for anagrelide hydrochloride, an oral platelet-lowering drug used primarily for essential thrombocythemia. Its commercial profile has shifted from a branded orphan-hematology product to a mature generic market. U.S. regulatory exclusivity and core patent protection have expired, generic substitution is established, and current revenue exposure is not separately disclosed by the product’s corporate owners.

What is Agrylin and how does it work?

Agrylin contains anagrelide hydrochloride in 0.5 mg and 1 mg capsules. The FDA approved Agrylin in 1997 for the treatment of patients with essential thrombocythemia who are at risk of thrombotic complications and require platelet reduction. The drug reduces platelet production by interfering with megakaryocyte maturation rather than directly destroying circulating platelets (FDA, 2011).

Anagrelide is used in a narrow hematology market:

• Essential thrombocythemia, a chronic myeloproliferative neoplasm
• Patients requiring cytoreduction because of thrombosis risk or extreme thrombocytosis
• Patients who do not tolerate, do not respond adequately to, or are not appropriate candidates for hydroxyurea
• Selected second-line patients treated under hematologist supervision

The principal competing therapies are hydroxyurea, pegylated interferon alfa, and, in limited circumstances, busulfan. Low-dose aspirin is commonly used for thrombosis prevention but is not a direct substitute for anagrelide’s platelet-lowering effect.

What is the FDA regulatory status of Agrylin?

Agrylin remains an FDA-approved product, but the market is no longer dependent on the branded product.

Regulatory item	Status
Active ingredient	Anagrelide hydrochloride
U.S. brand	Agrylin
Dosage form	Oral capsules
Strengths	0.5 mg and 1 mg
FDA application	NDA 020333
Initial U.S. approval	1997
Therapeutic area	Essential thrombocythemia
Regulatory pathway for competitors	Abbreviated New Drug Application
Current market structure	Brand plus multiple generic suppliers

FDA labeling warns of cardiovascular toxicity, including tachycardia, palpitations, cardiomyopathy, and congestive heart failure. The label also addresses pulmonary hypertension and hepatic or renal impairment. These safety considerations restrict broad use and support continued physician monitoring (FDA, 2011).

Anagrelide is also marketed outside the United States under names including Xagrid. In Europe, the product has been regulated as an orphan medicine for essential thrombocythemia, although European commercial ownership and distribution have differed from the U.S. structure (European Medicines Agency, 2004).

When did Agrylin lose exclusivity?

Agrylin lost meaningful U.S. market exclusivity years ago. The original small-molecule patent estate and regulatory exclusivity period expired before the current generic market developed.

U.S. exclusivity timeline

Event	Approximate timing	Commercial effect
FDA approval of Agrylin	1997	Originator commercial launch
Orphan-drug exclusivity period	Expired in the early 2000s	No remaining orphan exclusivity
Core U.S. patent protection	Expired before the current generic era	Opened the market to ANDA applicants
Generic approvals	2010s	Increased price and volume pressure
Current status	Mature generic market	Limited branded pricing power

The regulatory history does not indicate a current period of new chemical entity, orphan, pediatric, or other FDA exclusivity that would block generic competition. Anagrelide’s commercial value therefore depends on prescription demand, supply reliability, physician familiarity, and payer substitution rather than exclusivity.

What patents protect Agrylin?

No active, commercially significant U.S. Agrylin patent barrier is generally identified in current FDA product records. The relevant protection was based on older compound and product patents, not a recent formulation or delivery platform.

The practical patent assessment is:

Patent category	Current significance
Original anagrelide compound patents	Expired
Agrylin capsule patents	Expired or no longer commercially blocking
Salt-form protection	No material current U.S. barrier identified
Method-of-use patents	No active barrier generally recognized for ordinary essential-thrombocythemia treatment
Extended-release formulation patents	No established U.S. branded franchise
Manufacturing patents	Potentially relevant to cost and quality, but not a market-exclusion barrier
Orange Book-listed patents	No active listing generally relied on to delay generic entry

The absence of an active patent wall does not eliminate manufacturing risk. Anagrelide requires controlled production, validated dissolution performance, and consistent capsule content. Those requirements can affect supplier qualification and product availability, but they do not prevent ANDA competition.

What is the Orange Book status of Agrylin?

Agrylin is associated with FDA-approved NDA 020333. The Orange Book framework remains relevant for identifying listed patents and generic products, but the commercial question is whether an unexpired, enforceable patent is available to support a Paragraph IV dispute.

For Agrylin, the market has moved beyond that stage:

• Generic versions have entered through the ANDA pathway.
• No current branded patent listing is widely recognized as capable of delaying generic competition.
• A new generic entrant would generally face ordinary FDA approval and commercial execution risks, not a major patent injunction risk.
• The absence of a blocking patent reduces the likelihood of high-value patent litigation.

How many patents cover Agrylin?

The clinically relevant Agrylin product is not protected by a substantial active U.S. patent estate. Older patent records may include compound, salt, composition, or manufacturing claims associated with anagrelide, but expired patents do not provide current market exclusivity.

Patent strength can be summarized as follows:

Dimension	Assessment
Breadth	Low for current branded protection
Remaining life	No material core life remaining
Litigation leverage	Low
Formulation differentiation	Limited
Manufacturing know-how	Moderate operational value
Generic entry barrier	Low

A patent search may identify historical documents or foreign rights with different expiration dates. Those records should not be treated as evidence of a current U.S. barrier without confirming claim status, jurisdiction, and Orange Book relevance.

How has Agrylin’s revenue changed over time?

Agrylin generated meaningful revenue for its originator during the branded period because essential thrombocythemia is a chronic condition and treatment can continue for years. The product was still a small asset relative to the multibillion-dollar portfolios of Shire and later Takeda.

Public company reporting has not consistently provided current standalone Agrylin revenue. Shire historically reported Agrylin as an individual product or within its hematology portfolio, but later corporate transactions and portfolio reorganizations reduced transparency. Takeda’s post-acquisition reporting has generally focused on larger growth products and does not treat Agrylin as a material separately reported revenue driver (Shire plc, 2017; Takeda Pharmaceutical Company Limited, 2024).

Revenue trajectory

Period	Revenue profile	Primary driver
1997 to mid-2000s	Branded specialty-drug revenue	Orphan positioning and limited alternatives
Late 2000s to mid-2010s	Mature branded revenue	Chronic use and hematology familiarity
Generic-entry period	Declining branded share	ANDA competition and payer substitution
Post-generic market	Fragmented low-price revenue	Volume, supply reliability, and contract access
Current period	Not separately disclosed by major owner	Low strategic materiality

The key financial change was not a collapse in disease demand. Essential thrombocythemia remains a chronic treatment market. The change was the transfer of pricing power from the brand owner to generic manufacturers and purchasers.

What drives demand for anagrelide?

Demand is determined by the number of diagnosed essential-thrombocythemia patients, treatment guidelines, physician preference, and tolerability relative to hydroxyurea and interferon.

Anagrelide has several commercial advantages:

• Oral administration
• Direct platelet-lowering activity
• Long clinical experience
• Use in patients who cannot take hydroxyurea
• Availability as a low-dose capsule

Its limitations are clinically important:

• Cardiovascular adverse effects
• Headache, palpitations, diarrhea, and fluid-retention concerns
• Less favorable positioning than hydroxyurea for many high-risk patients
• Concerns regarding long-term disease outcomes in some treatment settings
• Need for dose titration and monitoring

The European LeukemiaNet has positioned anagrelide as a cytoreductive option, particularly when other therapies are unsuitable. Contemporary practice generally places it behind hydroxyurea or pegylated interferon for many first-line patients, which limits total addressable volume (Barbui et al., 2018).

What generic entry risks exist for Agrylin?

Generic entry risk is high because the product has a simple oral capsule dosage form and no meaningful remaining patent barrier.

Generic launch economics

Generic manufacturers compete on:

• FDA approval status
• Wholesale acquisition cost
• Medicaid and commercial payer contracts
• Pharmacy wholesaler access
• Supply continuity
• 0.5 mg and 1 mg strength availability
• Manufacturing cost and quality performance

The market is vulnerable to rapid price erosion because:

1. The drug is a conventional small molecule.
2. The indication is established and narrow.
3. Switching from brand to generic is operationally straightforward.
4. No complex delivery device is required.
5. Prescribers generally do not need a branded product for treatment initiation.

The main remaining opportunity is not premium pricing. It is dependable supply in a niche market where shortages or limited supplier participation can create temporary pricing dislocations.

Which companies compete with Agrylin?

Competition occurs at two levels: product-level generic competition and treatment-level clinical competition.

Product-level competitors

Generic anagrelide suppliers may include large and specialty generic manufacturers holding or marketing ANDA-approved products. Supplier participation can change because of discontinuations, shortages, pricing pressure, or portfolio rationalization.

Treatment-level competitors

Product or class	Role in essential thrombocythemia	Competitive position
Hydroxyurea	Common first-line cytoreduction	Strongest routine competitor
Pegylated interferon alfa	Cytoreduction, including selected younger patients	Important alternative
Busulfan	Later-line or selected patients	Limited use because of safety and long-term concerns
Aspirin	Thrombosis prevention	Adjunct, not a direct platelet-lowering substitute
Anagrelide	Alternative cytoreductive therapy	Strongest in intolerance or second-line use

The relevant competitive threat is therefore broader than another anagrelide capsule. Treatment guidelines and physician risk assessment determine whether a patient enters the anagrelide market at all.

What patent litigation or Paragraph IV challenges affect Agrylin?

No major active U.S. patent litigation is generally associated with Agrylin’s current market position. Generic entry has already occurred, and the core patent estate is expired.

The litigation profile is low for three reasons:

• No apparent active Orange Book patent creates a significant entry delay.
• The product has no high-value reformulation franchise.
• The market revenue is too limited to support prolonged branded litigation in most scenarios.

Earlier generic approvals could have involved Paragraph IV certifications, but the commercial importance of those disputes has passed. A future lawsuit would more likely concern manufacturing, supply contracts, product liability, or regulatory compliance than exclusionary patent rights.

Are biosimilar risks relevant to Agrylin?

No. Agrylin is a synthetic small-molecule drug, not a biologic. Biosimilar pathways do not apply.

The relevant competitive pathway is the ANDA process for generic anagrelide. This distinction matters commercially:

• No biologic reference-product exclusivity applies.
• No interchangeability designation under the biosimilar framework is required.
• Generic substitution is governed by conventional pharmaceutical substitution rules.
• Manufacturing complexity is lower than for monoclonal antibodies or other biologics.

What licensing deals affect Agrylin?

Agrylin’s commercial history has been shaped more by corporate portfolio transfers than by a major technology license.

Shire acquired and commercialized a broad specialty-pharmaceutical portfolio, and Takeda acquired Shire in 2019. Agrylin’s strategic value declined as generic competition developed. Current corporate reporting does not indicate a major standalone licensing transaction that materially changes the product’s exclusivity or revenue outlook (Takeda Pharmaceutical Company Limited, 2019).

Outside the United States, anagrelide rights have been commercialized through different regional arrangements. Those arrangements can affect product branding, distribution, and pricing, but they do not restore U.S. patent exclusivity.

How strong is the Agrylin commercial position?

Agrylin has moderate clinical durability but weak commercial defensibility.

Factor	Assessment
Disease persistence	Strong
Chronic treatment duration	Strong
Clinical differentiation	Moderate
First-line guideline position	Limited to moderate
Patent protection	Weak
Generic resistance	Weak
Manufacturing complexity	Low to moderate
Supply-chain value	Moderate
Revenue growth potential	Low
Strategic value to a large pharmaceutical company	Low
Value to a focused generic or specialty supplier	Moderate

A specialty supplier can still generate value from reliable supply, low overhead, and targeted distribution. A large innovator is unlikely to view Agrylin as a growth asset absent a new formulation, combination product, or materially differentiated delivery system.

What are the likely generic launch scenarios?

Base case: continued generic erosion

Generic suppliers retain the majority of volume, branded Agrylin remains marginal, and pricing follows standard mature-generic pressure. This is the most likely scenario.

Supply-constrained scenario

One or more suppliers exit because of low margins or manufacturing issues. Temporary shortages allow remaining suppliers to increase volume and preserve pricing. The effect would likely be episodic rather than structural.

Product-differentiation scenario

A company introduces a modified-release capsule, adherence-focused formulation, or specialty distribution model. Commercial success would require clinical or operational advantages because an ordinary anagrelide capsule has limited pricing power.

Reimbursement-driven scenario

Payers narrow preferred supplier networks or impose generic substitution. Brand volume declines even if physician demand for anagrelide remains stable.

Key Takeaways

• Agrylin is an oral anagrelide product for essential thrombocythemia.
• FDA approval dates to 1997, and meaningful U.S. exclusivity has expired.
• The current market is genericized and highly price-sensitive.
• No active patent estate is generally recognized as a material U.S. barrier to generic entry.
• There is no biosimilar risk because anagrelide is a small molecule.
• Hydroxyurea and pegylated interferon are the principal treatment-level competitors.
• Demand remains durable because essential thrombocythemia is chronic, but guideline positioning limits growth.
• Current standalone revenue is not separately disclosed by the major corporate owners.
• The strongest commercial opportunity is reliable low-cost supply, not branded price expansion.
• Patent litigation and Paragraph IV risk are low relative to manufacturing, supply, and reimbursement risks.

FAQs

Is Agrylin still available in the United States?

Yes. Agrylin is an FDA-approved brand, and generic anagrelide hydrochloride products are also available. Actual pharmacy availability depends on supplier status and distribution.

Is anagrelide safer than hydroxyurea?

Neither drug is universally safer. Anagrelide has specific cardiovascular risks, while hydroxyurea has different hematologic, cutaneous, and long-term monitoring considerations. Treatment selection depends on patient risk, age, comorbidities, prior therapy, and hematologist judgment.

Can generic anagrelide replace Agrylin?

Generic anagrelide is designed to provide the same active ingredient and dosage strengths as the brand. Substitution is generally governed by state pharmacy rules, payer policy, and the prescriber’s instructions.

Does Agrylin have orphan-drug exclusivity today?

No. Any original orphan-drug exclusivity associated with the 1997 approval has expired.

Could a new Agrylin formulation regain market exclusivity?

A new formulation could potentially receive separate patent protection or regulatory exclusivity if it met applicable legal requirements. That protection would apply to the qualifying new product, not automatically to ordinary anagrelide capsules.

References

Barbui, T., Tefferi, A., Vannucchi, A. M., Passamonti, F., Silver, R. T., Hoffman, R., Verstovsek, S., Mesa, R., Kiladjian, J.-J., Hehlmann, R., Reiter, A., Cervantes, F., Harrison, C., McMullin, M. F., & Hasselbalch, H. C. (2018). Philadelphia chromosome-negative classical myeloproliferative neoplasms: Revised management recommendations from European LeukemiaNet. Leukemia, 32(5), 1057-1069.

European Medicines Agency. (2004). Xagrid: EPAR - product information. European Medicines Agency.

Food and Drug Administration. (2011). Agrylin (anagrelide hydrochloride) capsules: Prescribing information. U.S. Department of Health and Human Services.

Shire plc. (2017). Annual report and accounts 2016. Shire plc.

Takeda Pharmaceutical Company Limited. (2019). Acquisition of Shire plc: Transaction documents and investor materials. Takeda Pharmaceutical Company Limited.

Takeda Pharmaceutical Company Limited. (2024). Annual report 2024. Takeda Pharmaceutical Company Limited.