Diclofenac sodium; misoprostol - Generic Drug Details
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What are the generic sources for diclofenac sodium; misoprostol and what is the scope of patent protection?
Diclofenac sodium; misoprostol
is the generic ingredient in two branded drugs marketed by Pfizer, Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.Twelve suppliers are listed for this compound.
Summary for diclofenac sodium; misoprostol
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 12 |
| DailyMed Link: | diclofenac sodium; misoprostol at DailyMed |
Pharmacology for diclofenac sodium; misoprostol
| Drug Class | Nonsteroidal Anti-inflammatory Drug Prostaglandin E1 Analog |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Anatomical Therapeutic Chemical (ATC) Classes for diclofenac sodium; misoprostol
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM; MISOPROSTOL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ARTHROTEC | Delayed-release Tablets | diclofenac sodium; misoprostol | 50 mg/0.2 mg | 020607 | 1 | 2009-06-29 |
| ARTHROTEC | Delayed-release Tablets | diclofenac sodium; misoprostol | 75 mg/0.2 mg | 020607 | 1 | 2008-11-28 |
US Patents and Regulatory Information for diclofenac sodium; misoprostol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 | |||
| Exela Holdings | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 200540-002 | Mar 14, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | AB | RX | Yes | 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 diclofenac sodium; misoprostol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | ⤷ 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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