PEPCID COMPLETE Drug Patent Profile
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When do Pepcid Complete patents expire, and when can generic versions of Pepcid Complete launch?
Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA.
The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for PEPCID COMPLETE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 35 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PEPCID COMPLETE |
| What excipients (inactive ingredients) are in PEPCID COMPLETE? | PEPCID COMPLETE excipients list |
| DailyMed Link: | PEPCID COMPLETE at DailyMed |
Recent Clinical Trials for PEPCID COMPLETE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ohio State University Comprehensive Cancer Center | Phase 2/Phase 3 |
| Leidos Life Sciences | Phase 2 |
| United States Department of Defense | Phase 2 |
Pharmacology for PEPCID COMPLETE
| Drug Class | Histamine-2 Receptor Antagonist |
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for PEPCID COMPLETE
Paragraph IV (Patent) Challenges for PEPCID COMPLETE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PEPCID COMPLETE | Chewable Tablets | calcium carbonate; famotidine; magnesium hydroxide | 800 mg/10 mg/ 165 mg (OTC) | 020958 | 1 | 2004-11-01 |
US Patents and Regulatory Information for PEPCID COMPLETE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | OTC | 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 PEPCID COMPLETE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| J And J Consumer Inc | PEPCID COMPLETE | calcium carbonate; famotidine; magnesium hydroxide | TABLET, CHEWABLE;ORAL | 020958-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PEPCID COMPLETE
See the table below for patents covering PEPCID COMPLETE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Netherlands | 180420 | ⤷ Try a Trial | |
| Portugal | 97739 | PROCESSO PARA A PREPARACAO DE UMA PASTILHA MEDICAMENTOSA MASCAVEL E PARA MASCARAR O SABOR DE MEDICAMENTOS | ⤷ Try a Trial |
| Australia | 728423 | ⤷ Try a Trial | |
| United Kingdom | 2055800 | GUANIDINOTHIAZOLES AND THEIR PREPARATION AND USE | ⤷ Try a Trial |
| Germany | 3008056 | ⤷ Try a Trial | |
| Canada | 1145345 | METHODE DE PREPARATION DE COMPOSES A BASE DE GUANIDINOTHIAZOLE (PROCESS FOR PREPARING GUANIDINOTHIAZOLE COMPOUNDS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PEPCID COMPLETE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2957286 | SPC/GB19/003 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721 |
| 2365988 | LUC00061 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 0521471 | C300125 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106 |
| 2365988 | 2018C/006 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 2957286 | 1990003-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721 |
| 0720599 | CR 2014 00050 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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