Pentosan polysulfate sodium - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Taiwan University Hospital | Phase 2/Phase 3 |
TCM Biotech International Corporation | Phase 2/Phase 3 |
Paradigm Biopharmaceuticals USA (INC) | Phase 3 |
Pharmacology for pentosan polysulfate sodium
Drug Class | Glycosaminoglycan |
Anatomical Therapeutic Chemical (ATC) Classes for pentosan polysulfate sodium
US Patents and Regulatory Information for pentosan polysulfate sodium
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
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
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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.