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Last Updated: April 25, 2024

PENTOSAN POLYSULFATE SODIUM - Generic Drug Details

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What are the generic sources for pentosan polysulfate sodium and what is the scope of freedom to operate?

Pentosan polysulfate sodium is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for pentosan polysulfate sodium. One supplier is listed for this compound.

Summary for PENTOSAN POLYSULFATE SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in PENTOSAN POLYSULFATE SODIUM?	PENTOSAN POLYSULFATE SODIUM excipients list
DailyMed Link:	PENTOSAN POLYSULFATE SODIUM at DailyMed

Recent Clinical Trials for PENTOSAN POLYSULFATE SODIUM

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Sponsor	Phase
National Taiwan University Hospital	Phase 2/Phase 3
TCM Biotech International Corporation	Phase 2/Phase 3
Paradigm Biopharmaceuticals USA (INC)	Phase 3

See all PENTOSAN POLYSULFATE SODIUM clinical trials

Pharmacology for PENTOSAN POLYSULFATE SODIUM

Drug Class	Glycosaminoglycan

US Patents and Regulatory Information for PENTOSAN POLYSULFATE SODIUM

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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
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193-001	Sep 26, 1996		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 PENTOSAN POLYSULFATE SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ELMIRON	pentosan polysulfate sodium	CAPSULE;ORAL	020193-001	Sep 26, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for PENTOSAN POLYSULFATE SODIUM

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
bene-Arzneimittel GmbH	Elmiron	pentosan polysulfate sodium	EMEA/H/C/004246 Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.,	Authorised	no	no	no	2017-06-02
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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