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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
TCM Biotech International Corporation | Phase 2/Phase 3 |
National Taiwan University Hospital | 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 | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
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