OVRAL-28 Drug Patent Profile

When do Ovral-28 patents expire, and what generic alternatives are available?

Ovral-28 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in OVRAL-28 is ethinyl estradiol; norgestrel. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for OVRAL-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
DailyMed Link:	OVRAL-28 at DailyMed

US Patents and Regulatory Information for OVRAL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for OVRAL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982	3,666,858
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982	3,959,322
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982	3,850,911

International Patents for OVRAL-28

See the table below for patents covering OVRAL-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	716736
Cyprus	658	Pharmaceutical compositions
Denmark	130949
United Kingdom	1204171
United Kingdom	1204172

Supplementary Protection Certificates for OVRAL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

OVRAL-28 Market Dynamics and Financial Trajectory: Revenue Outlook, Pricing Pressure, and Exclusivity Risk

Last updated: July 30, 2026

OVRAL-28’s market dynamics and financial trajectory depend on three drivers: (1) regulatory status and launch timeline, (2) patent and exclusivity positioning versus generic and biosimilar entry pathways, and (3) commercial execution tied to payer coverage and dosing economics. No credible market, financial, or regulatory record for “OVRAL-28” is available in the provided context, and the drug cannot be mapped to a known INN, brand, active ingredient, NDA/BLA, or regulatory dossier.

What is OVRAL-28 and what market does it target?

A complete market dynamics and financial trajectory assessment requires OVRAL-28’s identity (active ingredient, dosage form, route, sponsor, and regulatory application). Without a verifiable mapping to an FDA-approved or clinically active drug, the analysis cannot support: product category sizing, payer mix assumptions, competitor set definition, or pricing benchmarks.

What active ingredient and dosage form is OVRAL-28?

No verifiable INN/brand-to-active mapping for OVRAL-28 is present in the supplied information. Without the active ingredient and formulation, drug-level pricing and market comparison are not actionable.

Is OVRAL-28 an NDA or BLA product, and which pathway?

Market and financial trajectory materially differ if OVRAL-28 is:

• an FDA-approved small molecule (NDA),
• a biologic (BLA),
• a biosimilar/comparable follow-on,
• or an unapproved investigational product.

No regulatory pathway data is available for OVRAL-28 in the provided context.

When does OVRAL-28 lose exclusivity and face generic entry risks?

Exclusivity timing is the anchor for financial trajectory. For a launch-era or mature product, revenue durability depends on:

• statutory exclusivity end date (5, 7, or 9 years depending on basis),
• pediatric exclusivity,
• patent expiration by Orange Book listings,
• and paragraph IV filing and litigation/settlement posture.

No Orange Book listings, patent numbers, filing dates, or FDA exclusivity metadata are available for OVRAL-28 in the provided context. Without them, the generic entry risk timeline cannot be produced.

What patents protect OVRAL-28 and what is their expiration schedule?

No patent estate (list of U.S. patents, expiration dates, assignees, and claims coverage) is provided for OVRAL-28.

Are there paragraph IV challenges or settlements tied to OVRAL-28?

No Paragraph IV notice events, district court filings, or settlement announcements are provided.

What is the Orange Book status of OVRAL-28?

Orange Book status (listed patents, dosage forms, and regulatory exclusivity) determines where revenue is protected and where payer contracting risk begins.

No Orange Book entry for OVRAL-28 is provided in the supplied information, so the following cannot be stated:

• whether OVRAL-28 has an Orange Book listing,
• which patents are listed and for which dosage forms,
• and whether exclusivity is still active.

How does OVRAL-28 compare with competing therapies in pricing, access, and utilization?

Market dynamics require a competitor map by:

• therapeutic class,
• line of therapy,
• administration/dosing frequency,
• efficacy and safety positioning,
• and payer authorization criteria.

No OVRAL-28 clinical or commercial attributes are available (indication, efficacy metrics, dosing schedule, or payer coverage posture). Without those, competitor comparison cannot be constructed.

What are the key payer coverage dynamics for OVRAL-28?

Coverage dynamics usually vary by:

• formulary tier placement,
• prior authorization requirements,
• step therapy,
• utilization management triggers,
• and specialty pharmacy channeling.

No payer or channel information is available for OVRAL-28 in the provided context.

What is the dosing and cost-per-course that drives revenue?

Revenue trajectory depends on:

• treatment duration,
• dose titration rules,
• wastage assumptions,
• and total annualized cost.

No dosing regimen or unit economics are available for OVRAL-28.

What formulation or method-of-use IP barriers affect OVRAL-28 generics?

Formulation and method-of-use patents can block entry even after core composition claims expire. These are typically identified through:

• Orange Book patent types (drug substance, drug product, method of use),
• and related continuation/divisional filings.

No OVRAL-28 patent coverage by category is provided, so IP barrier analysis cannot be produced.

What patent litigation affects OVRAL-28’s commercial timeline?

Patent litigation can delay generic entry and reshape settlement-driven launch calendars. Required inputs include:

• court case numbers,
• asserted patents,
• filing dates,
• injunction posture,
• and final judgment or settlement terms.

No litigation records are provided for OVRAL-28 in the supplied context.

Which companies are challenging OVRAL-28 and what is the competitive launch scenario?

Paragraph IV challengers and biosimilar developers are the primary indicators of imminent erosion in pricing and volume. Required elements are:

• ANDA sponsors,
• FDA application submission and status,
• notice letters,
• and launch readiness signals.

No challenger or application data for OVRAL-28 is provided.

What is OVRAL-28’s revenue trajectory and how exposed is it to pricing pressure?

A financial trajectory needs at least one of:

• company reported net sales,
• investor presentations,
• commercial payer data or prescription trends,
• or market research with citations.

No OVRAL-28 revenue, units, prescriptions, pricing, or financial reporting is included in the provided context. Without a verifiable sales record, an evidence-based revenue trajectory cannot be stated.

Key takeaways

• No credible drug-level identification, FDA regulatory status, Orange Book listing, patent estate, or financial record for OVRAL-28 is available in the provided context.
• Market dynamics and revenue trajectory cannot be generated without mapping OVRAL-28 to an active ingredient, regulator dossier, and documented exclusivity/patent position.

FAQs

1. What information is required to determine generic entry timing for an FDA-listed drug?
2. How do Orange Book drug product versus method-of-use patents change generic launch risk?
3. What metrics best predict pricing pressure once exclusivity ends (net price, rebates, WAC-to-net spread)?
4. How do paragraph IV litigation timelines typically affect FDA approval-to-launch gaps?
5. What differences in market dynamics occur between small-molecule NDAs and biologic BLA/Biosimilar pathways?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations (database). https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-30).