ELMIRON Drug Patent Profile
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When do Elmiron patents expire, and when can generic versions of Elmiron launch?
Elmiron is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in ELMIRON is pentosan polysulfate sodium. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pentosan polysulfate sodium profile page.
Summary for ELMIRON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ELMIRON |
| What excipients (inactive ingredients) are in ELMIRON? | ELMIRON excipients list |
| DailyMed Link: | ELMIRON at DailyMed |
Recent Clinical Trials for ELMIRON
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 |
| Cancer Research Network | Phase 2 |
Pharmacology for ELMIRON
| Drug Class | Glycosaminoglycan |
Anatomical Therapeutic Chemical (ATC) Classes for ELMIRON
US Patents and Regulatory Information for ELMIRON
| 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 ELMIRON
| 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 ELMIRON
| 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 |
