UZEDY Drug Patent Profile

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When do Uzedy patents expire, and what generic alternatives are available?

Uzedy is a drug marketed by Teva and is included in one NDA. There are nine patents protecting this drug.

This drug has seventy-six patent family members in thirty-four countries.

The generic ingredient in UZEDY is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Uzedy

A generic version of UZEDY was approved as risperidone by APOTEX INC on September 15^th, 2008.

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Summary for UZEDY

International Patents:	76
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for UZEDY
What excipients (inactive ingredients) are in UZEDY?	UZEDY excipients list
DailyMed Link:	UZEDY at DailyMed

Drug patent expirations by year for UZEDY

Pharmacology for UZEDY

Drug Class	Atypical Antipsychotic

US Patents and Regulatory Information for UZEDY

UZEDY is protected by nine US patents and one FDA Regulatory Exclusivity.

Patents protecting UZEDY

Risperidone biodegradable implant
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Drug-containing implants and methods of use thereof
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Risperidone-containing PLA:PGA implants and methods of use thereof
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Biodegradable drug delivery compositions
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Risperidone-containing implants and methods of use thereof
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Drug-containing implants and methods of use thereof
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Drug-containing PLA implants and methods of use thereof
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Drug-containing implants and methods of use thereof
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FDA Regulatory Exclusivity protecting UZEDY

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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	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-004	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-006	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for UZEDY

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406 Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for UZEDY

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	2658525		⤷ Sign Up
Mexico	347090	COMPOSICIONES DE SUMINISTRO DE FARMACOS BIODEGRADABLES. (BIODEGRADABLE DRUG DELIVERY COMPOSITIONS.)	⤷ Sign Up
Singapore	191414	BIODEGRADABLE DRUG DELIVERY COMPOSITIONS	⤷ Sign Up
China	103637977	Drug-containing implants and methods of use thereof	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for UZEDY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium	⤷ Sign Up	PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description