PRIMATENE MIST Drug Patent 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. Seventeen 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: | 4,576 |
| 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 |
Pharmacology for PRIMATENE MIST
| Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PRIMATENE MIST
US Patents and Regulatory Information for PRIMATENE MIST
PRIMATENE MIST is protected by one US patents.
Patents protecting PRIMATENE MIST
Stable epinephrine suspension formulation with high inhalation delivery efficiency
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Wyeth Cons | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 016126-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
