DICLOFENAC SODIUM AND MISOPROSTOL Drug Patent Profile
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Which patents cover Diclofenac Sodium And Misoprostol, and what generic alternatives are available?
Diclofenac Sodium And Misoprostol is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms. and is included in seven NDAs.
The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diclofenac Sodium And Misoprostol
A generic version of DICLOFENAC SODIUM AND MISOPROSTOL was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.
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Summary for DICLOFENAC SODIUM AND MISOPROSTOL
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Patent Applications: | 1 |
| What excipients (inactive ingredients) are in DICLOFENAC SODIUM AND MISOPROSTOL? | DICLOFENAC SODIUM AND MISOPROSTOL excipients list |
| DailyMed Link: | DICLOFENAC SODIUM AND MISOPROSTOL at DailyMed |
Pharmacology for DICLOFENAC SODIUM AND MISOPROSTOL
| Drug Class | Nonsteroidal Anti-inflammatory Drug Prostaglandin E1 Analog |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
US Patents and Regulatory Information for DICLOFENAC SODIUM AND MISOPROSTOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 201089-001 | Jul 9, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 204355-001 | Jul 15, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 203995-002 | Nov 25, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Yung Shin Pharm | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 205143-002 | Feb 19, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 204355-002 | Jul 15, 2021 | AB | RX | 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 |
