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 |
| United States Department of Defense | Phase 2 |
| Leidos Life Sciences | 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 |
| >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 |
|---|---|---|---|
| European Patent Office | 0600725 | Compositions pharmaceutiques contenant un guanidinothiazole et des antiacides (Pharmaceutical compositions containing a guanidinothiazole and antacids) | ⤷ Try a Trial |
| Germany | 2951675 | ⤷ Try a Trial | |
| Spain | 2274550 | ⤷ Try a Trial | |
| Philippines | 16099 | GUANIDINOTHIAZOLE COMPOUNDS,PROCESS FOR PREPARING THEM AND MEDICAL COMPOSITION CONTAINING THEM | ⤷ 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 |
|---|---|---|---|---|
| 0720599 | 300689 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912 |
| 2957286 | 132019000000021 | Italy | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721 |
| 2957286 | C02957286/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017 |
| 2957286 | 6/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721 |
| >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.
ISSN: 2162-2639
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