GASTROCROM Drug Patent Profile
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Which patents cover Gastrocrom, and what generic alternatives are available?
Gastrocrom is a drug marketed by Ucb Inc and Mylan Speciality Lp and is included in two NDAs.
The generic ingredient in GASTROCROM is cromolyn sodium. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gastrocrom
A generic version of GASTROCROM was approved as cromolyn sodium by SANDOZ on June 16th, 1999.
Summary for GASTROCROM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 98 |
| Clinical Trials: | 3 |
| Patent Applications: | 6,417 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GASTROCROM |
| What excipients (inactive ingredients) are in GASTROCROM? | GASTROCROM excipients list |
| DailyMed Link: | GASTROCROM at DailyMed |
Recent Clinical Trials for GASTROCROM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Northwestern University | Early Phase 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Early Phase 1 |
| Aradign Corportation | Phase 1 |
Pharmacology for GASTROCROM
| Drug Class | Mast Cell Stabilizer |
| Physiological Effect | Decreased Histamine Release |
US Patents and Regulatory Information for GASTROCROM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | GASTROCROM | cromolyn sodium | CAPSULE;ORAL | 019188-001 | Dec 22, 1989 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 GASTROCROM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | GASTROCROM | cromolyn sodium | CAPSULE;ORAL | 019188-001 | Dec 22, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GASTROCROM
See the table below for patents covering GASTROCROM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| France | 2493146 | MELANGE DE CROMOGLYCATE DE SODIUM AVEC UN EXCIPIENT HYDROSOLUBLE ET PROCEDE POUR SA PREPARATION POUR TRAITER LES AFFECTIONS DU TRACTUS GASTRO-INTESTINAL | ⤷ Try a Trial |
| Canada | 1166571 | COMPOSE PHARMACEUTIQUE (PHARMACEUTICAL FORMULATION) | ⤷ Try a Trial |
| France | 2365565 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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