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PRIMATENE MIST Drug Profile
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Which patents cover Primatene Mist, and when can generic versions of Primatene Mist launch?
Primatene Mist is a drug marketed by Armstrong Pharms and Wyeth Cons and is included in two NDAs. There is one patent protecting this drug.
The generic ingredient in PRIMATENE MIST is epinephrine. There are twenty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Primatene Mist
A generic version of PRIMATENE MIST was approved as epinephrine by BELCHER on July 29th, 2014.
Summary for PRIMATENE MIST
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,439 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in PRIMATENE MIST? | PRIMATENE MIST excipients list |
| DailyMed Link: | PRIMATENE MIST at DailyMed |
Recent Clinical Trials for PRIMATENE MIST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amphastar Pharmaceuticals, Inc. | Phase 3 |
ATC Classes for PRIMATENE MIST
US Patents and Regulatory Information for PRIMATENE MIST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Armstrong Pharms | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 205920-001 | Nov 7, 2018 | OTC | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Armstrong Pharms | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 205920-001 | Nov 7, 2018 | OTC | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Wyeth Cons | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 016126-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
