promacta Drug Patent Profile

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

Promacta is a drug marketed by Novartis and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Promacta

A generic version of promacta was approved as eltrombopag olamine by ANNORA PHARMA on April 18^th, 2024.

Summary for promacta

International Patents:	135
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	31
Patent Applications:	409
Drug Prices:	Drug price information for promacta
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for promacta
What excipients (inactive ingredients) are in promacta?	promacta excipients list
DailyMed Link:	promacta at DailyMed

See drug prices for promacta

Recent Clinical Trials for promacta

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

Sponsor	Phase
University of California, San Francisco	Phase 1
Food and Drug Administration (FDA)	Phase 1
University of California, Davis	Phase 1

See all promacta clinical trials

Pharmacology for promacta

Drug Class	Thrombopoietin Receptor Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Paragraph IV (Patent) Challenges for PROMACTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROMACTA	Tablets	eltrombopag olamine	12.5 mg and 25 mg	022291	1	2014-02-04
PROMACTA	Tablets	eltrombopag olamine	50 mg and 75 mg	022291	1	2014-01-07

US Patents and Regulatory Information for promacta

promacta is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011	AB	RX	Yes	No	8,828,430*PED				Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No	8,071,129*PED				Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes	8,071,129*PED				Y

International Patents for promacta

When does loss-of-exclusivity occur for promacta?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

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 promacta around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	1295199
Australia	1295299
Australia	1369499

Supplementary Protection Certificates for promacta

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	C300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1294378	CA 2010 00017	Denmark
1294378	91681	Luxembourg		PRODUCT NAME: ELTROMBOPAG, EVENTUELLEMENT SOUS FORME D'UN SEL OU D'UN SOLVATE (Y COMPRIS SOUS FORME D'UN HYDRATE) PHARMACEUTIQUEMENT ACCEPTABLE (REVOLADE ); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001-006 - REVOLADE-ELTROMBOPAG 20100315

Last updated: July 20, 2026

PROMACTA market dynamics and financial trajectory (eltrombopag)

Executive summary: PROMACTA (eltrombopag) is an eltrombopag-based thrombopoietin receptor agonist with a long-running commercial footprint in immune thrombocytopenia (ITP) and chronic liver disease–associated thrombocytopenia (CLD-ITP). Market dynamics are shaped by (1) label breadth and switching between ITP and CLD-ITP use cases, (2) payer restrictions and prior authorization tied to response and bleeding-risk criteria, (3) competitive pressure from other thrombopoietin receptor agonists (notably avatrombopag and lusutrombopag for CLD-ITP and broader hematology positioning), and (4) the future share impact of biosimilar or generic risk is low for this small-molecule, but patent/extension and brand exclusivity drive near-to-mid term defensibility. Financial trajectory has been supported by persistent demand for refractory ITP, expanded CLD use, and uptake via specialty channels, while the growth rate has moderated as mature-market penetration increased.

---

PROMACTA sales trend: how has eltrombopag revenue evolved by indication?

Short answer: PROMACTA revenue growth has historically tracked ITP demand durability and CLD-ITP conversion, then decelerated as the brand matured and payers tightened usage criteria.

Immune thrombocytopenia (ITP) dynamics

• PROMACTA is positioned for persistent or chronic ITP, including patients who have inadequate response to corticosteroids, immunoglobulins, or other treatments.
• Commercial durability in ITP is driven by:
  • clinician reliance on predictable platelet count response cycles
  • patient persistence in chronic refractory populations
  • ongoing formulary coverage in hematology specialty plans

Chronic liver disease–associated thrombocytopenia (CLD-ITP) dynamics

• For CLD patients who require thrombocytopenia management before procedures or to reduce bleeding risk, PROMACTA is used when compatible with prescribing and monitoring protocols.
• Revenue sensitivity in CLD-ITP comes from:
  • procedure volumes (endoscopy, surgery, interventional radiology)
  • payer policy on TPO-RA selection and time windows pre-procedure
  • lab monitoring and discontinuation rules

Operational and pricing forces

• Specialty pharmacy throughput and adherence drive realized net sales.
• Rebates and discounts tighten as competitors gain traction in CLD procedure pathways, especially where payer formularies segment by clinical criteria.

---

What market forces drive PROMACTA pricing, payer coverage, and net price?

Short answer: Net price is driven by payer placement in hematology and gastro/hepatology formularies, plus prior authorization gates that tie access to baseline platelet counts and documented response.

Key payer levers

• Prior authorization requirements:
  • diagnosis confirmation (ITP vs CLD)
  • baseline platelet count thresholds
  • documentation of prior therapies for ITP
• Step therapy and criteria:
  • may require trial of corticosteroids or immunoglobulin for ITP
• Duration controls:
  • requirement to show platelet response before continued coverage

Channel and contracting

• PROMACTA is sold through specialty distributors and specialty pharmacy networks.
• Contracting targets:
  • manufacturer list price versus effective price after rebates
  • formulary tier placement with major pharmacy benefit managers

Net sales implications

• If payer policy tightens, realized net sales can fall even if prescriptions stay stable.
• If competition intensifies in CLD procedure cohorts, net price pressure is typically higher in that segment than in chronic refractory ITP.

---

How does competition in thrombocytopenia affect PROMACTA share and revenue growth?

Short answer: PROMACTA faces competitive pressure most visibly in CLD-ITP cohorts from avatrombopag and lusutrombopag and, to a lesser extent, from other TPO-RA usage preferences in ITP sequencing.

Direct comparator landscape

• Thrombopoietin receptor agonists:
  • avatrombopag (CLD indications and procedure timing positioning)
  • lusutrombopag (CLD indications and procedure timing positioning)
• ITP positioning overlap:
  • the TPO-RA class overlaps in chronic refractory patient populations
  • selection is influenced by dosing schedule preference, safety profile perceptions, payer criteria, and physician experience

Share shift mechanisms

• CLD procedure timing:
  • if payers prefer certain agents with specific pre-procedure time windows, share can reallocate quickly in that cohort
• Formulary switching:
  • hematology formularies can also shift with clinical guideline adoption and contracting

Revenue impact pattern

• Mature ITP demand tends to be steadier.
• Competitive share shifts tend to hit incremental growth first, then net price.

---

When does PROMACTA lose exclusivity and what does that mean for financial risk?

Short answer: The financial risk profile is anchored to the patent estate and any regulatory exclusivities covering eltrombopag and specific PROMACTA presentations. In practice, the near-term financial trajectory is usually driven by how much life remains in composition-of-matter and formulation or method-of-use patents listed in the Orange Book.

Exclusivity risk pathways to watch

• Generic challenge pathway:
  • Paragraph IV filings could compress future pricing if triggered.
• Settlement and authorized generics:
  • negotiated settlements can lead to staged or delayed generic entry.
• Formulation and method-of-use barriers:
  • even if a core composition-of-matter expires, downstream patents can restrict specific dosing regimens or use populations.

Commercial timing effects

• Investors and commercial planners typically model:
  • peak-to-plateau sales levels
  • downside from formulary replacement
  • margin compression from generic or authorized generic entry

(Orange Book status and specific expiration dates are required for exact timing. This analysis is constrained to market dynamics and financial trajectory without listing the full patent-by-patent exclusivity schedule.)

---

What is PROMACTA’s FDA regulatory posture and how does it affect commercialization?

Short answer: PROMACTA is an approved, branded therapy with established labeling and long-term clinical use, so commercialization is mainly driven by maintaining safety label interpretation and sustaining payer confidence.

Regulatory commercialization mechanics

• Risk management and monitoring:
  • thrombosis risk considerations and platelet monitoring drive prescribing patterns and persistence
• Label interpretation:
  • hepatology guidance and procedure workflows influence uptake in CLD-ITP
• Postmarketing evidence:
  • real-world prescribing patterns and safety surveillance can affect formulary confidence

---

How strong is the promotional and specialty channel footprint for PROMACTA?

Short answer: PROMACTA’s commercialization depends on specialty hematology distribution, patient support programs, and clinician-driven selection in refractory ITP and selected CLD pathways.

What sustains uptake

• Long-term clinician familiarity
• Established monitoring protocols and dose adjustment routines
• Patient support infrastructure that reduces adherence friction

What can constrain growth

• Payer restriction increases
• Treatment sequencing constraints in guidelines
• Competitive contracting shifts in CLD procedure cohorts

---

What generic entry risks exist for PROMACTA and how could they impact sales?

Short answer: The main financial threat is not “immediate generic substitution” but staged entry after patent challenges or settlements that unwind exclusivity. The likely pattern is:

1. initial erosion in the most contestable plan formularies
2. slower patient switching in ITP due to familiarity and management routines
3. sharper erosion in CLD procedure use if competitors are preferred under payer criteria

Modeling generic impact

• Pricing compression:
  • net sales typically fall quickly after generic availability
• Volume retention:
  • some continued prescribing can occur if patients stabilize on current therapy or if payer contracts do not immediately force switching
• Contract migration:
  • specialty pharmacies often implement preferred product substitutions based on rebate structures

---

PROMACTA vs avatrombopag vs lusutrombopag: how does competitive positioning differ?

Short answer: PROMACTA competes with other TPO-RAs primarily on indication fit and payer preference, with the sharpest differentiation in CLD-ITP procedure pathway selection.

Decision points that drive prescribing

• Procedural timing requirements
• Eligibility criteria and lab thresholds used in CLD cohorts
• Cost and payer access:
  • preferred-agent contracting in gastroenterology procedural settings
• Treatment duration:
  • clinicians prefer regimens that match procedure workflows

Net effect on financial trajectory

• In ITP, PROMACTA’s mature use base supports steadier revenue.
• In CLD-ITP, share and net price can move faster due to competitive switching and contracting.

---

What does PROMACTA’s financial trajectory imply for margin and earnings sensitivity?

Short answer: PROMACTA’s profitability is sensitive to net price, rebate intensity, and channel mix. As competition increases, margins compress first through price concessions, then through higher contracting costs.

Key margin drivers

• Net-to-gross ratio trends:
  • rebate and discount changes driven by formulary access
• Specialty distribution costs:
  • adherence and fulfillment stability
• Portfolio mix:
  • if hematology revenue allocation shifts, overall company margin impact changes

Scenario impact

• Baseline: steady ITP demand and stable net pricing.
• Downside: CLD share erosion and payer tightening.
• Stress case: competitive entry or exclusivity unwind coupled with rapid formulary substitution.

---

Key takeaways

• PROMACTA’s financial trajectory is primarily a function of chronic refractory ITP durability and CLD-ITP uptake, moderated by payer access constraints.
• Competitive pressure is most pronounced in CLD procedure cohorts from other TPO-RA agents, which can accelerate share shifts and net price erosion.
• Exclusivity unwind and any Paragraph IV or settlement-driven generic entry are the primary long-term financial risks, with the most rapid erosion expected where payer contracting forces substitution.
• Near-to-mid term performance hinges on net price maintenance through contracting and on preserving formulary placement in specialty hematology plans.

---

FAQs

1. What payer criteria most often restrict PROMACTA access in chronic ITP?
2. How do CLD procedure volumes and lab monitoring affect PROMACTA prescription seasonality?
3. Which PROMACTA competitive contracts are most likely to shift net price in gastroenterology/hepatology formularies?
4. How would a delayed generic launch vs an early launch change modeled PROMACTA revenue erosion timing?
5. What formulation or patient-support elements most influence PROMACTA persistence in long-term ITP therapy?

---

References

1. APA: No cited sources were provided in the prompt.

DrugChatter Q&A for PROMACTA

Promacta and generic status?
When is loss of exclusivity promacta?
When does promacta go generic?
Promacta revolade loss of exclusivity usa?
When will patent for promacta in new zealand end?