Cromolyn sodium - Generic Drug Details
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What are the generic 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 |
|---|---|
| Adli Karadsheh, MD, MS | Phase 3 |
| Texas Tech University Health Sciences Center, El Paso | Phase 3 |
| APCER | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Inc | CROMOLYN SODIUM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 075615-001 | Jan 26, 2001 | DISCN | 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 | ||||
| Micro Labs Ltd India | CROMOLYN SODIUM | cromolyn sodium | CONCENTRATE;ORAL | 202745-001 | Apr 4, 2013 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | INTAL | cromolyn sodium | CAPSULE;INHALATION | 016990-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075333-001 | Apr 30, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | CROMOLYN SODIUM | cromolyn sodium | SOLUTION;INHALATION | 075271-001 | Jan 18, 2000 | AN | RX | No | Yes | ⤷ 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 |
|---|---|---|---|---|---|---|---|
| Allergan | OPTICROM | cromolyn sodium | SOLUTION/DROPS;OPHTHALMIC | 018155-001 | Oct 3, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ 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 | AEROSOL, METERED;INHALATION | 018887-001 | Dec 5, 1985 | ⤷ 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 |
| Sanofi Aventis Us | INTAL | cromolyn sodium | CAPSULE;INHALATION | 016990-001 | Approved Prior to Jan 1, 1982 | ⤷ 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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