Pseudoephedrine hydrochloride - Generic Drug Details
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What are the generic sources for pseudoephedrine hydrochloride and what is the scope of patent protection?
Pseudoephedrine hydrochloride
is the generic ingredient in sixteen branded drugs marketed by Sanofi Aventis Us, Glaxosmithkline, Aurobindo Pharma, L Perrigo Co, Sun Pharm Inds Ltd, Mcneil Cons, J And J Consumer Inc, Kv Pharm, Cenci, Usl Pharma, Newtron Pharms, Pvt Form, Chartwell Rx, Sandoz, Teva, Watson Labs, West Ward, Ivax Sub Teva Pharms, and Superpharm, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for pseudoephedrine hydrochloride. Thirty-two suppliers are listed for this compound.
Summary for pseudoephedrine hydrochloride
| US Patents: | 0 |
| Tradenames: | 16 |
| Applicants: | 19 |
| NDAs: | 23 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 69 |
| Patent Applications: | 2,321 |
| What excipients (inactive ingredients) are in pseudoephedrine hydrochloride? | pseudoephedrine hydrochloride excipients list |
| DailyMed Link: | pseudoephedrine hydrochloride at DailyMed |
Recent Clinical Trials for pseudoephedrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eurofarma Laboratorios S.A. | Phase 3 |
| John Muir Health | N/A |
| University of Maryland, Baltimore | Phase 4 |
Pharmacology for pseudoephedrine hydrochloride
| Drug Class | alpha-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for pseudoephedrine hydrochloride
US Patents and Regulatory Information for pseudoephedrine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cenci | ACTAHIST | pseudoephedrine hydrochloride; triprolidine hydrochloride | SYRUP;ORAL | 088344-001 | Feb 9, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Kv Pharm | TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES | pseudoephedrine hydrochloride; triprolidine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 071798-001 | Mar 16, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | SUDAFED 12 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 073585-001 | Oct 31, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | ACTIFED | pseudoephedrine hydrochloride; triprolidine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 018996-001 | Jun 17, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | SUDAFED 12 HOUR | pseudoephedrine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 017941-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | TRIPHED | pseudoephedrine hydrochloride; triprolidine hydrochloride | TABLET;ORAL | 088630-001 | May 17, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Sub Teva Pharms | TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | pseudoephedrine hydrochloride; triprolidine hydrochloride | TABLET;ORAL | 085273-001 | Dec 12, 1984 | DISCN | No | No | ⤷ 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 pseudoephedrine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | SUDAFED 24 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020021-002 | Dec 15, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| J And J Consumer Inc | SUDAFED 24 HOUR | pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020021-002 | Dec 15, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
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