CROMOLYN SODIUM - Generic Drug Details
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What are the generic drug sources for cromolyn sodium and what is the scope of patent protection?
Cromolyn sodium
is the generic ingredient in seven branded drugs marketed by King Pharms Llc, Sanofi Aventis Us, Ucb Inc, Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Mylan Speciality Lp, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms Inc, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Hh And P, Perrigo, and Blacksmith Brands, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for cromolyn sodium. Eighteen suppliers are listed for this compound.
Summary for CROMOLYN SODIUM
US Patents: | 0 |
Tradenames: | 7 |
Applicants: | 27 |
NDAs: | 31 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 23 |
Patent Applications: | 8,076 |
What excipients (inactive ingredients) are in CROMOLYN SODIUM? | CROMOLYN SODIUM excipients list |
DailyMed Link: | CROMOLYN SODIUM at DailyMed |
Recent Clinical Trials for CROMOLYN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Texas Tech University Health Sciences Center, El Paso | Phase 3 |
Adli Karadsheh, MD, MS | Phase 3 |
MedAvante | Phase 2 |
Pharmacology for CROMOLYN SODIUM
Drug Class | Mast Cell Stabilizer |
Physiological Effect | Decreased Histamine Release |
Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM
US Patents and Regulatory Information for CROMOLYN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | OPTICROM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 018155-001 | Oct 3, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ailex Pharms Llc | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 209453-001 | Oct 16, 2017 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Virtus | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075437-001 | Apr 21, 2000 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch And Lomb | CROLOM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 074443-001 | Jan 30, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
King Pharms Llc | INTAL | cromolyn sodium | SOLUTION;INHALATION | 018596-001 | May 28, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hh And P | CROMOLYN SODIUM | cromolyn sodium | SPRAY, METERED;NASAL | 077976-001 | Sep 7, 2007 | 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 CROMOLYN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
King Pharms Llc | INTAL | cromolyn sodium | AEROSOL, METERED;INHALATION | 018887-001 | Dec 5, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ Sign Up | ⤷ Sign Up |
King Pharms Llc | INTAL | cromolyn sodium | SOLUTION;INHALATION | 018596-001 | May 28, 1982 | ⤷ Sign Up | ⤷ Sign Up |
King Pharms Llc | INTAL | cromolyn sodium | AEROSOL, METERED;INHALATION | 018887-001 | Dec 5, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OPTICROM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 018155-001 | Oct 3, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | OPTICROM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 018155-001 | Oct 3, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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