CROMOLYN SODIUM Drug Patent Profile
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Which patents cover Cromolyn Sodium, and when can generic versions of Cromolyn Sodium launch?
Cromolyn Sodium is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Apotex Inc, Sandoz, Sciegen Pharms, Actavis Mid Atlantic, Bausch, Eugia Pharma, Fera Pharms Llc, Hikma, Micro Labs, Roxane, Teva Pharms, Watson Labs, Wockhardt Bio Ag, Bausch And Lomb, Hh And P, and Perrigo. and is included in twenty-two NDAs.
The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cromolyn Sodium
A generic version of CROMOLYN SODIUM was approved as cromolyn sodium by SANDOZ on June 16th, 1999.
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Summary for CROMOLYN SODIUM
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 23 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ailex Pharms Llc | CROMOLYN SODIUM | cromolyn sodium | CONCENTRATE;ORAL | 209264-001 | Oct 16, 2017 | AA | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Wockhardt Bio Ag | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075346-001 | Oct 25, 1999 | AN | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sciegen Pharms | CROMOLYN SODIUM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 074706-001 | Apr 29, 1998 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | CROMOLYN SODIUM | cromolyn sodium | CONCENTRATE;ORAL | 202583-001 | Oct 27, 2011 | AA | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
