ALVAIZ Drug Patent Profile

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

Alvaiz is a drug marketed by Teva Pharms Inc and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ALVAIZ is eltrombopag choline. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag choline profile page.

DrugPatentWatch^® Generic Entry Outlook for Alvaiz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 5, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ALVAIZ

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ALVAIZ
What excipients (inactive ingredients) are in ALVAIZ?	ALVAIZ excipients list
DailyMed Link:	ALVAIZ at DailyMed

Drug patent expirations by year for ALVAIZ

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

Generic Entry Date for ALVAIZ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 216774 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.

Pharmacology for ALVAIZ

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

US Patents and Regulatory Information for ALVAIZ

ALVAIZ is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALVAIZ is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ALVAIZ

Solid state forms of eltrombopag choline
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY

Solid state forms of eltrombopag choline
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY

Solid state forms of eltrombopag choline
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-001	Nov 29, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-003	Nov 29, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-002	Nov 29, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-004	Nov 29, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ALVAIZ

When does loss-of-exclusivity occur for ALVAIZ?

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

European Patent Office

Patent: 92021
Patent: FORMES À L'ÉTAT SOLIDE D'ELTROMBOPAG CHOLINE (SOLID STATE FORMS OF ELTROMBOPAG CHOLINE)
Estimated Expiration: ⤷ Sign Up

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 ALVAIZ around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019071111		⤷ Sign Up
European Patent Office	3692021	FORMES À L'ÉTAT SOLIDE D'ELTROMBOPAG CHOLINE (SOLID STATE FORMS OF ELTROMBOPAG CHOLINE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALVAIZ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	122010000037	Germany	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
1294378	23/2010	Austria	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 20100315
1534390	PA2010007	Lithuania	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
1534390	91 3-2010	Slovakia	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description