SALAGEN Drug Patent Profile
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When do Salagen patents expire, and what generic alternatives are available?
Salagen is a drug marketed by Concordia and is included in one NDA.
The generic ingredient in SALAGEN is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Salagen
A generic version of SALAGEN was approved as pilocarpine hydrochloride by PADAGIS US on November 16th, 2004.
Summary for SALAGEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,839 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SALAGEN |
| What excipients (inactive ingredients) are in SALAGEN? | SALAGEN excipients list |
| DailyMed Link: | SALAGEN at DailyMed |
Recent Clinical Trials for SALAGEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Pharma Europe B.V. | Phase 1 |
| Federal University of São Paulo | Phase 3 |
| Roxane Laboratories | N/A |
Pharmacology for SALAGEN
| Drug Class | Cholinergic Receptor Agonist |
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SALAGEN
US Patents and Regulatory Information for SALAGEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concordia | SALAGEN | pilocarpine hydrochloride | TABLET;ORAL | 020237-001 | Mar 22, 1994 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Concordia | SALAGEN | pilocarpine hydrochloride | TABLET;ORAL | 020237-002 | Apr 18, 2003 | AB | 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 |
