By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
DrugPatentWatch Database Preview
ANNOVERA Drug Profile
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When do Annovera patents expire, and what generic alternatives are available?
Annovera is a drug marketed by Therapeuticsmd Inc and is included in one NDA. There are six patents protecting this drug.
The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Annovera
Annovera will be eligible for patent challenges on August 10, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 21, 2039. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ANNOVERA
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ANNOVERA |
| What excipients (inactive ingredients) are in ANNOVERA? | ANNOVERA excipients list |
| DailyMed Link: | ANNOVERA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ANNOVERA
Generic Entry Date for ANNOVERA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
RING;VAGINAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ANNOVERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| TherapeuticsMD | Phase 1 |
Pharmacology for ANNOVERA
| Drug Class | Progestin Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for ANNOVERA
International Patents for ANNOVERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Try Before You Buy | ||
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ANNOVERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 300814 | Netherlands | Try Before You Buy | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | CA 2016 00016 | Denmark | Try Before You Buy | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1214076 | C01214076/01 | Switzerland | Try Before You Buy | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 0136011 | 2000C/027 | Belgium | Try Before You Buy | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| 1214076 | 49/2008 | Austria | Try Before You Buy | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
