DOPTELET Drug Patent Profile

When do Doptelet patents expire, and when can generic versions of Doptelet launch?

Doptelet is a drug marketed by Akarx Inc and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in DOPTELET is avatrombopag maleate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Doptelet

Doptelet was eligible for patent challenges on May 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DOPTELET

US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	7
Patent Applications:	133
Drug Prices:	Drug price information for DOPTELET
What excipients (inactive ingredients) are in DOPTELET?	DOPTELET excipients list
DailyMed Link:	DOPTELET at DailyMed

See drug prices for DOPTELET

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

Constraining patent/regulatory exclusivity:

TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

NDA:

210238

Dosage:

TABLET;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.

Recent Clinical Trials for DOPTELET

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

Sponsor	Phase
Sobi, Inc.	Phase 3
The First Affiliated Hospital of Soochow University	Phase 2/Phase 3
Chinese PLA General Hospital	Phase 4

See all DOPTELET clinical trials

US Patents and Regulatory Information for DOPTELET

DOPTELET is protected by one US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT.

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
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes			Y	Y
Akarx Inc	DOPTELET SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696-001	Jul 24, 2025		RX	Yes	Yes
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes

Expired US Patents for DOPTELET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018

International Patents for DOPTELET

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

Country	Patent Number	Title	Estimated Expiration
Canada	2472711	DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF)
China	1319967
China	1639157
Cyprus	1114169

Supplementary Protection Certificates for DOPTELET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	CA 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912	2019C/547	Belgium		PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
1466912	301020	Netherlands		PRODUCT NAME: AVATROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER AVATROMBOPAG-MALEAAT; REGISTRATION NO/DATE: EU/1/19/1373 20190624
1466912	LUC00137	Luxembourg		PRODUCT NAME: AVATROMBOPAG OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624

Last updated: July 22, 2026

Doptelet (avatrombopag) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

Doptelet (avatrombopag) has matured from launch into a late-cycle, niche thrombocytopenia franchise tied to chronic immune thrombocytopenia (ITP) and peri-procedural platelet management. Growth has been supported by incremental label coverage, payer uptake, and ongoing treatment switching among hematology practices, while financial performance increasingly reflects (1) immunology and hematology market share dynamics, (2) new agent diffusion in chronic ITP, and (3) the timing of oral thrombopoietin receptor agonist (TPO-RA) competitive pressure and generic/biosimilar-style risks are not the core issue because Doptelet is a small-molecule with conventional patent exclusivity mechanics.

What is Doptelet (avatrombopag) used for and where does revenue come from?

Doptelet is a TPO-RA used to increase platelet counts. Commercial utilization is concentrated in two settings that drive distinct payer behavior and switching patterns: (1) chronic ITP for durable, long-term platelet control and (2) peri-procedural platelet management where dose timing and response predict post-procedure safety.

Chronic ITP revenue driver: what product positioning wins

• Oral, once-daily administration supports outpatient hematology workflows.
• Durable platelet response reduces rescue bleeding interventions and procedure delays.
• In clinical practice, Doptelet competes most directly against other oral TPO-RAs and, indirectly, against non-TPO RA ITP approaches (splenectomy, rituximab, and newer ITP agents depending on line-of-therapy).

Peri-procedural use: what determines uptake

• Patients are enrolled through gastroenterology, dermatology, ophthalmology, and other procedural specialties that coordinate with hematology.
• Adoption depends on provider familiarity with dosing windows, platelet monitoring, and payer authorization speed.

How has Doptelet performed financially since launch and what is the trajectory?

Doptelet’s financial trajectory has followed a typical small-molecule hematology adoption curve: initial ramp, stabilization after formulary consolidation, and later-cycle growth or flattening tied to (1) label capture, (2) switching among TPO-RA users, and (3) competitive intensity from other ITP therapies.

Key market dynamics shaping the trajectory:

• TPO-RA category maturity: growth is harder once most eligible patients are already on an established oral strategy.
• Net price pressure: as payer formularies evolve, rebates and access conditions typically tighten.
• Mix effects: peri-procedural use tends to be lumpy by quarter and depends on procedure volumes and payer approvals; chronic use is steadier.

What typically changes quarterly revenue

• Growth accelerants: new formulary wins, increased persistence, and improved patient flow from specialty clinics.
• Drag factors: prior authorization delays, higher utilization of alternative agents, or discontinuations tied to response variability.

What patents protect Doptelet and how does patent life affect market durability?

Doptelet is protected by a layered small-molecule patent estate plus data exclusivity and regulatory exclusivity regimes for new indications and formulations. Patent expiration timing is a primary determinant of long-horizon revenue durability.

Which exclusivity mechanisms matter

• Regulatory exclusivity (data and marketing exclusivity) delays approval of competing products even if patents are challenged.
• Patent claims covering compound, composition, formulations, and/or therapeutic use shape the practical launch date for any generic entrant.

How exclusivity affects competitive behavior

• Where patent coverage is tight, branded-to-generic competitive risk is low in the near term, shifting competitive threats to branded or category peers rather than conventional generics.

When does Doptelet lose exclusivity and what generic entry risks exist?

Generic entry risk is constrained by the combination of the patent estate and FDA regulatory exclusivity. The dominant question for generic challengers is whether they can carve around claimed subject matter or prevail on an invalidity/non-infringement posture through Paragraph IV filings.

Paragraph IV pathway relevance

• For small molecules like avatrombopag, Paragraph IV challenges can target specific listed patents. Practical generic launch depends on litigation outcomes and potential settlement carve-outs.

What generic launch would require in practice

• An ANDA filing with an approved bioequivalence route and a successful legal posture against listed patents.
• Ability to meet formulation/manufacturing specs without infringing composition or method-of-use claims.

What formulations are protected by Doptelet patents?

Doptelet’s product is an oral dosage form. Patent coverage often includes:

• Specific chemical entities and salts/polymorphs where relevant.
• Composition claims tied to tablet formulation.
• Manufacturing method claims for tablet production.
• Potential method-of-use claims tied to dosing regimens for thrombocytopenia indications.

Because commercially meaningful exclusivity usually includes composition and method layers, formulation patents can block “workaround” launches even when compound claims are not asserted or later expire.

What is the Orange Book status of Doptelet?

Orange Book listing status determines:

• Which patents are listed for each approved NDA and dosage form.
• Which patents are eligible targets for Paragraph IV challenges.
• The practical window for “at-risk” generic launches and associated litigation probability.

How strong is the patent estate for avatrombopag versus competing TPO-RAs?

Doptelet competes inside the TPO-RA ecosystem. Patent strength is measured less by who has more patents and more by whether the listed patents are:

• Widely asserted
• Unexpired near the relevant generic entry windows
• Supported by valid claim scope that would be hard to design around

In matured franchises, the strongest estate typically delays generic substitution even if some older patents expire, because other listed patents keep the product locked in.

Which companies are competing with Doptelet for chronic ITP and peri-procedural platelet management?

Competitive intensity comes from:

• Other TPO-RAs used for ITP (oral competitors dominate switching).
• Later-line hematology pipelines depending on response needs and contraindication profiles.

How competitive positioning affects market share

• If peers achieve better payer access or patient outcomes in specific subpopulations (e.g., prior TPO-RA failures), switching can shift share quickly.
• If Doptelet maintains persistence and consistent platelet response, it can retain a stable base even when category volumes do not grow.

How does Doptelet compare with other ITP therapies on access, dosing, and payer placement?

Direct differentiation tends to be driven by:

• Dosing simplicity and administration schedule
• Platelet response durability patterns in real-world hematology practice
• Formulary status (preferred vs restricted tiers)
• Prior authorization and step edits

Where access is most sensitive

• Payers often apply tighter utilization management in chronic ITP once competitors reach preferred status.
• Peri-procedural use can face different access gates based on indication-specific coverage rules.

What patent litigation affects Doptelet and could it change market timing?

Litigation matters in two ways:

• It can delay generic approvals, pushing entry beyond “paper” expiration dates.
• Settlements can create time-limited triggers for market entry, sometimes with carve-out labeling or delayed launch until specific dates.

For an installed branded product, litigation outcomes change the commercial risk profile more than they change near-term clinical practice.

What is the FDA regulatory status of Doptelet and how does it influence revenue?

FDA status affects revenue through:

• Label scope (what patient segments are eligible for use)
• Post-marketing obligations (safety updates)
• Any restrictions tied to warnings, monitoring, or dosing requirements

Once label coverage is stable, revenue shifts primarily reflect payer access and competitive diffusion.

How does payer coverage and formulary strategy influence Doptelet’s financial trajectory?

Chronic ITP is high-need but managed carefully:

• Preferred formulary placement increases prescriptions and continuation.
• Non-preferred tiers increase rejections, appeals, and delays.
• Dose monitoring requirements can raise clinician and staff burden, which can affect adoption among less specialized sites.

Contracting and net revenue

Net sales reflect:

• Rebates and discounts tied to formulary status and volume commitments
• Patient support programs that can improve persistence but do not erase reimbursement pressure
• Commercial mix changes across geographies and prescriber settings

Revenue exposure: how much of Doptelet sales are sensitive to competitive substitution?

Sensitivity is highest where:

• Patients are relatively treatment-naïve and can switch among TPO-RAs quickly after failure or incomplete response.
• Payers tighten access on older therapies when newer TPO-RAs or differentiated agents become preferred.

It is lower where:

• Doptelet shows established persistence and stable platelet response after switching history makes changes harder.
• Patients achieve durable control and remain on the same regimen.

How does Doptelet compare with other oral TPO-RAs on market maturity and risk of price erosion?

Across mature hematology franchises:

• Category leaders typically face slower unit growth but can protect net pricing through contracting leverage and strong clinical fit.
• Price erosion accelerates when multiple oral options are equally reimbursed and physicians can switch without meaningful administrative friction.

Doptelet’s risk profile is therefore driven by access breadth and net price trajectory rather than any imminent generic substitution cliff in the near term.

What do market dynamics suggest for Doptelet over the next 3–5 years?

Near-term outlook is shaped by:

• Maintaining chronic ITP base through persistence
• Expanding procedural utilization within label-approved patterns
• Defending payer position against branded and category peers
• Planning around patent and exclusivity milestones that determine when at-risk competition becomes realistic

In matured ITP markets, growth typically comes more from share gains and payer access refinement than from new patient pool expansion.

Key Takeaways

• Doptelet’s revenue trajectory is primarily a function of chronic ITP persistence, peri-procedural use patterns, and payer formulary placement within the oral TPO-RA category.
• Patent and regulatory exclusivity determine conventional generic substitution risk; competitive pressure in practice is more often branded/category substitution than immediate generic entry.
• Financial performance should be tracked through net price dynamics (rebates and discounts), utilization management changes (prior authorization and tiering), and evidence of share movement within TPO-RA-treated ITP patients.
• The next 3–5 years likely hinge on defending formulary access and maintaining continuation rates while preparing for longer-horizon patent-expiration-driven risk.

FAQs

1. How do prior authorization and step edits impact Doptelet net sales by quarter?
2. What patient subgroups in chronic ITP are most likely to switch among oral TPO-RAs?
3. How do settlement agreements and patent carve-outs change the timeline for potential ANDA launches?
4. Does peri-procedural platelet management create seasonal or event-driven revenue swings for Doptelet?
5. Which endpoints in real-world hematology practice best correlate with Doptelet continuation rates?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Doptelet/avatrombopag). U.S. Food and Drug Administration.
2. FDA. Drug Approval Package: Doptelet (avatrombopag). U.S. Food and Drug Administration.
3. SEC. Public filings and earnings materials for Doptelet’s commercial sponsor and relevant TPO-RA competitors (annual reports, quarterly reports, investor presentations). U.S. Securities and Exchange Commission.