RISPERIDONE - Generic Drug Details

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What are the generic drug sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Teva, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fifty-four NDAs. There are thirty-eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has three hundred and thirty-two patent family members in forty-three countries.

There are thirty drug master file entries for risperidone. Thirty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RISPERIDONE

International Patents:	332
US Patents:	38
Tradenames:	7
Applicants:	44
NDAs:	54
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	557
Patent Applications:	6,401
Drug Prices:	Drug price trends for RISPERIDONE
Drug Sales Revenues:	Drug sales revenues for RISPERIDONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISPERIDONE
What excipients (inactive ingredients) are in RISPERIDONE?	RISPERIDONE excipients list
DailyMed Link:	RISPERIDONE at DailyMed

See drug prices for RISPERIDONE

Drug Sales Revenue Trends for RISPERIDONE

See drug sales revenues for RISPERIDONE

Recent Clinical Trials for RISPERIDONE

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

Sponsor	Phase
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
Instituto de Salud Carlos III	Phase 4
Assiut University	Phase 4

See all RISPERIDONE clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RISPERIDONE

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for RISPERIDONE

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for RISPERIDONE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RISPERIDONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for RISPERIDONE

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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
Ratiopharm	RISPERIDONE	risperidone	TABLET;ORAL	077784-001	Jun 8, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	RISPERIDONE	risperidone	SOLUTION;ORAL	076904-001	Jul 29, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Renata	RISPERIDONE	risperidone	TABLET;ORAL	078707-005	Dec 29, 2008	AB	RX	No	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

Expired US Patents for RISPERIDONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-004	Dec 23, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for RISPERIDONE

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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 RISPERIDONE

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201401346	ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ИМПЛАНТИРУЕМОЙ ФОРМЫ РИСПЕРИДОНА ИЛИ ПАЛИПЕРИДОНА	⤷ Sign Up
Japan	6216364		⤷ Sign Up
South Africa	201304687	BIODEGRADABLE DRUG DELIVERY COMPOSITIONS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RISPERIDONE

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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

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